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American
National
Standard
ANSI/AAMI
PREVIEW COPY :2013/
ST77
This is a preview edition of an AAMI guidance document and is
(R)2018
intended to allow potential purchasers to evaluate the content
of the document before making a purchasing decision.
For a complete copy of this AAMI document, contact AAMI at
Containment devices for
+1-877-249-8226 or visit www.aami.org.
reusable medical device
sterilization
Advancing Safety in Health Technology

Objectives and uses of AAMI standards and

recommended practices
It is most important that the objectives and potential uses of an Each AAMI standard or recommended practice reflects the
AAMI product standard or recommended practice are clearly collective expertise of a committee of health care professionals and
understood. The objectives of AAMI's technical development industrial representatives, whose work has been reviewed
program derive from AAMI's overall mission: the advancement of nationally (and sometimes internationally). As such, the consensus
medical instrumentation. Essential to such advancement are (1) a recommendations embodied in a standard or recommended practice
continued increase in the safe and effective application of current are intended to respond to clinical needs and, ultimately, to help
technologies to patient care, and (2) the encouragement of new ensure patient safety. A standard or recommended practice is
technologies. It is AAMI's view that standards and recommended limited, however, in the sense that it responds generally to
practices can contribute significantly to the advancement of perceived risks and conditions that may not always be relevant to
medical instrumentation, provided that they are drafted with specific situations. A standard or recommended practice is an
attention to these objectives and provided that arbitrary and important reference in responsible decision-making, but it should
restrictive uses are avoided. never replace responsible decision-making.
A voluntary standard for a medical device recommends to the Despite periodic review and revision (at least once every five
manufacturer the information that should be provided with or on years), a standard or recommended practice is necessarily a static
the product, basic safety and performance criteria that should be document applied to a dynamic technology. Therefore, a standards
considered in qualifying the device for clinical use, and the user must carefully review the reasons why the document was
measurement techniques that can be used to determine whether the initially developed and the specific rationale for each of its
device conforms with the safety and performance criteria and/or to provisions. This review will reveal whether the document remains
compare the performance characteristics of different products. relevant to the specific needs of the user.
Some standards emphasize the information that should be provided Particular care should be taken in applying a product standard
with the device, including performance characteristics, instructions to existing devices and equipment, and in applying a recommended
for use, warnings and precautions, and other data considered practice to current procedures and practices. While observed or
important in ensuring the safe and effective use of the device in the potential risks with existing equipment typically form the basis for
clinical environment. Recommending the disclosure of the safety and performance criteria defined in a standard,
performance characteristics often necessitates the development of professional judgment must be used in applying these criteria to
specialized test methods to facilitate uniformity in reporting; existing equipment. No single source of information will serve to
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reaching consensus on these tests can represent a considerable part identify a particular product as "unsafe". A voluntary standard can
of committee work. When a drafting committee determines that be used as one resource, but the ultimate decision as to product
clinical concerns warrant the establishment of minimum safety and safety and efficacy must take into account the specifics of its
performance criteria, referee tests must be provided and the reasons utilization and, of course, cost-benefit considerations. Similarly, a
This is a preview edition of an AAMI
for establishing the criteria must be documented in the rationale.
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A recommended practice provides guidelines for the use, care, purchasers
specificto evaluate
needs theofcontent
and resources the individual institution or firm.
and/or processing of a medical of the document before making a purchasing decision. each AAMI standard and
device or system. A recommended Again, the rationale accompanying
practice does not address device performance per se, but rather recommended practice is an excellent guide to the reasoning and
procedures and practices that will help ensure that a device is used data underlying its provision.
safely and effectively andFor a complete
that its copy
performance will of this AAMI document,
be maintained. In summary,contact
a standardAAMI at
or recommended practice is truly
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Although a device standard is primarily directed to the or visit www.aami.org.
useful only when it is used in conjunction with other sources of
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Similarly, even though a recommended practice is usually oriented
towards healthcare professionals, it may be useful to the INTERPRETATIONS OF AAMI STANDARDS
manufacturer in better understanding the environment in which a AND RECOMMENDED PRACTICES
medical device will be used. Also, some recommended practices,
while not addressing device performance criteria, provide Requests for interpretations of AAMI standards and recommended
guidelines to industrial personnel on such subjects as sterilization practices must be made in writing, to the AAMI Vice President,
processing, methods of collecting data to establish safety and Standards Policy and Programs. An official interpretation must be
efficacy, human engineering, and other processing or evaluation approved by letter ballot of the originating committee and
techniques; such guidelines may be useful to health care subsequently reviewed and approved by the AAMI Standards
professionals in understanding industrial practices. Board. The interpretation will become official and representation of
In determining whether an AAMI standard or recommended the Association only upon exhaustion of any appeals and upon
practice is relevant to the specific needs of a potential user of the publication of notice of interpretation in the "Standards Monitor"
document, several important concepts must be recognized: section of the AAMI News. The Association for the Advancement
All AAMI standards and recommended practices are voluntary of Medical Instrumentation disclaims responsibility for any
(unless, of course, they are adopted by government regulatory or characterization or explanation of a standard or recommended
procurement authorities). The application of a standard or practice which has not been developed and communicated in
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professional judgment of the user of the document. appropriate notice, as an official interpretation in the AAMI News.
American National Standard ANSI/AAMI ST77:2013/(R)2018

(Revision of ANSI/AAMI ST77:2006)
Containment devices for

reusable medical device sterilization
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Developed by
AAMI
Approved 1 February 2013 and reaffirmed 6 September 2018 by

American National Standards Institute Inc.
Abstract: This standard covers minimum labeling and performance requirements for rigid sterilization
container systems and for instrument organizers.
Keywords: containment devices, reusable rigid sterilization containers, instrument organizers.

AAMI Standard
This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those
substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect
preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or
using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic
review, and users are cautioned to obtain the latest editions.
CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that
action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of publication.
Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the
AAMI website at www.aami.org.
All AAMI standards, recommended practices, technical information reports, and other types of technical documents
developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the
user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies
or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and
regulations.
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Published by
AAMI
4301 N. Fairfax Dr., Suite 301
Arlington, VA 22203-1633
www.aami.org
© 2013 by the Association for the Advancement of Medical Instrumentation
All Rights Reserved
Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this
document without the prior written permission of the Association for the Advancement of Medical Instrumentation is
strictly prohibited by law. It is illegal under federal law (17 U.S.C. § 101, et seq.) to make copies of all or any part of
this document (whether internally or externally) without the prior written permission of the Association for the
Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and
damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the
reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633.
Phone: +1-703-525-4890; Fax: +1-703-525-1067.
Printed in the United States of America
ISBN 978-1-57020-485-2
Contents
Page
Glossary of equivalent standards .................................................................................................................................. iv

Committee representation .............................................................................................................................................. v
Foreword ...................................................................................................................................................................... viii
Introduction .................................................................................................................................................................... 1
1 Scope...................................................................................................................................................................... 1
1.1 General ............................................................................................................................................................ 1
1.2 Inclusions ......................................................................................................................................................... 2
1.3 Exclusions........................................................................................................................................................ 2
2 Normative references .............................................................................................................................................. 3

3 Definitions and abbreviations .................................................................................................................................. 4
4 Requirements.......................................................................................................................................................... 7
4.1 General ............................................................................................................................................................ 7
4.2 Materials of construction .................................................................................................................................. 7
4.2.1 Durability ........................................................................................................................................... 7
4.2.2 Compatibility with the sterilization process ........................................................................................ 7
4.2.3 Corrosion resistance.......................................................................................................................... 7
4.2.4 Biocompatibility.................................................................................................................................. 7
4.3 Design.............................................................................................................................................................. 7
4.3.1 General .............................................................................................................................................. 7
4.3.2 Decontamination................................................................................................................................ 8
4.3.3 Perforations ....................................................................................................................................... 8
4.3.4 Stacking ............................................................................................................................................. 8
4.3.5 Maximum weight................................................................................................................................ 9
4.3.6
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Additional requirements for reusable rigid sterilization containers ..................................................... 9
4.4 Performance .................................................................................................................................................. 11
4.4.1 Sterilization ...................................................................................................................................... 11
4.4.2 This is a (ifpreview
Drying applicable)edition of an AAMI guidance document and is
........................................................................................................................ 12
4.4.3 Sterilant residual removal (if applicable) .......................................................................................... 13
4.4.4 intended to allow.......................................................................................................................
Sterility maintenance potential purchasers to evaluate the content 13
4.5 Labeling requirements ................................................................................................................................... 14
4.5.1 Device markings .............................................................................................................................. 14
4.5.2 Instructions for use (IFU) ................................................................................................................. 14
5 Tests ..................................................................................................................................................................... 16
5.1 General .......................................................................................................................................................... 16
5.2 Biocompatibility .............................................................................................................................................. 16
5.3 Gaskets and filters ......................................................................................................................................... 16
5.4 Valves ............................................................................................................................................................ 16
5.5 Handles.......................................................................................................................................................... 16
5.6 Sterilization .................................................................................................................................................... 16
5.7 Drying (if applicable) ...................................................................................................................................... 18
5.8 Sterilant residual removal (if applicable) ........................................................................................................ 18
5.9 Sterility ........................................................................................................................................................... 18
5.9.1 Sterility maintenance ....................................................................................................................... 18
Annexes
A Medical Device Integration With Rigid Sterilization Container Systems ................................................................ 19

Bibliography ................................................................................................................................................................. 23
Tables
1 Biological indicators for various sterilization processes ........................................................................................ 17
A.1 Critical assessment comparison tool..................................................................................................................... 20
Glossary of equivalent standards
International Standards adopted in the United States may include normative references to other International
Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI).
Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of
equivalency to the International Standard.
www.aami.org/standards/glossary.pdf
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iv © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

Committee representation
Association for the Advancement of Medical Instrumentation

Reusable Sterilization Container Working Group
This standard was developed by the AAMI Reusable Sterilization Container Working Group under the auspices of the
AAMI Sterilization Standards Committee. Approval of the standard does not necessarily mean that all working group
members voted for its approval. At the time this standard was published, the AAMI Reusable Sterilization
Container Working Group had the following members:
Co-Chairs: Damien Berg, Medical Center of the Rockies
Joan M. Spear, B Braun of America Inc.
Members: Navin Agarwal, Medline Industries Inc.
Edward Arscott, Johnson & Johnson
Damien Berg, Medical Center of the Rockies
Angela H. Brightwell, Medtronic Inc. WHQ Campus
Renee Camp, Moog Medical Devices
Nancy Chobin, RN CSPDM, St Barnabas Healthcare System
Susan Christensen, CareFusion
Linda Clement, CRCST, Steris Corporation
Linda Condon, Johns Hopkins Hospital
Ramona Conner, RN MSN CNOR, Association of periOperative Registered Nurses
Jacqueline Daley, Sinai Hospital of Baltimore
April J. Doering, St Jude Medical Inc.
Mary Ann Drosnock, MS, Olympus America Inc.
Betty D. Edge, Northshore University Hospital
Steven J. Elliott, NAMSA
Sue Ellen Erickson, MS CNOR, Newark Beth Israel Medical Center
Rosanna Fardo, RN BSN CIC CHSP, Department of Veterans Affairs
Susan Flynn, 3M Healthcare
Marcia Ann Frieze, Case Medical Inc.
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Shelley Green, WuXi AppTec Inc.
Charles Oren Hancock, RAC, H&W Technology LLC
Sybil Hickes, Materials Management Microsystems
This is a A.
Charles preview
Hughes, SPS edition
Medical of anCorp
Supply AAMI guidance document and is
Geetha C. Jayan, PhD, FDA/CDRH
intended to allow potential purchasers
David W. Johnson, Kimberly-Clark Corporation to evaluate the content
Susan G. Klacik, CCSMC FCS ACE, IAHCSMM
Colleen Patricia Landers, RN, Landers Consulting
Mary Kneece Lane, BS MHA CSPDS CSPDM, Sarasota Memorial Hospital
For a complete
Helene Leblond, TSO3 copy
Inc. of this AAMI document, contact AAMI at
+1-877-249-8226
Teckla A. Maresca, or visit
LPN CSPDM, St Clare's Healthwww.aami.org.
System
Dennis Moore, CRCST FCS, Fletcher Allen Health Care
Thomas K. Moore
Karen Nauss, CRCST, Mount Auburn Hospital
Gerry A. O'Dell, MS, Gerry O'Dell Consulting
Rodney D. Parker, Stryker Instruments Division
Anthony Powell, Getinge USA
Rose E. Seavey, RN MBA CNOR CRCST, Seavey Healthcare Consulting, LLC
Frank Sizemore, Wake Forest University - Baptist Medical Center
Linda Slone, RN BSPA CNOR
Joan M. Spear, B Braun of America Inc.
Betty Strickland, Pryce Consultants
Karen Swanson, Connecticut Childrens Medical Center
R. Brent Sweet, Zimmer Inc.
Raymond Taurasi, MBA CRCST CHL FCS AC, Healthmark Ind Co Inc.
Nora E. Wikander, RN,CSPDM, St Josephs Wayne Hospital
Martha Young, Association for Professionals in Infection Control and Epidemiology
Alternates: Terence A. Alwin, Medline Industries Inc.
Ralph J. Basile, MBA, Healthmark Ind Co Inc.
Sylvie Dufresne, PhD, TSO3 Inc.
Steven Elliott, FDA/CDRH
© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 v

Gordon M. Ely, WuXi AppTec Inc.

Jeff Felgar, Zimmer Inc.
Naomi Gamm, St Jude Medical Inc.
Rachel Hill, CareFusion
Natalie Lind, IAHCSMM
Tania Lupu, Case Medical Inc.
Michael Neilson, Nelson Laboratories Inc.
Edward Nuber, B Braun of America Inc.
Richard T. O'Donnell, Steris Corporation
Patrick Polito, Moog Medical Devices
Janet M. Prust, 3M Healthcare
Shaundrea L. Rechsteiner, NAMSA
Mandy Ryan, Stryker Instruments Division
Barb Smith, Getinge USA
Gary J. Socola, SPS Medical Supply Corp
Jonathan A. Wilder, PhD, H&W Technology LLC
Su-Syin S. Wu, PhD, Johnson & Johnson
NOTE--Participation by federal agency representatives in the development of this document does not constitute
endorsement by the federal government or any of its agencies.
AAMI Sterilization Standards Committee

Co-Chairs: Victoria M. Hitchins, PhD, FDA/CDRH
Michael H. Scholla, Dupont Protection Technologies
Members: Trabue D. Bryans, WuXi AppTec Inc.
Peter A. Burke, PhD, Steris Corporation
Nancy Chobin, RN CSPDM, St Barnabas Healthcare System (Independent Expert)
Charles Cogdill, Boston Scientific Corporation
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Ramona Conner, RN MSN CNOR, Association of periOperative Registered Nurses
Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology
Kimbrell Darnell, CR Bard
Dave Dion, Cardinal Health (MP&S)
This is Foster,
Lisa a preview edition
Sterigenics of an AAMI guidance document and is
International
intended to
Joel R. Gorski,allow potential
PhD, NAMSA purchasers to evaluate the content
Deborah A. Havlik, Hospira Worldwide Inc.
of the
Victoria document
M. Hitchins, before making a purchasing decision.
PhD, FDA/CDRH
Lois Atkinson Jones, MS, (Independent Expert)
For a complete
Susan copyFCS
G. Klacik, CCSMC of this
ACE, AAMI
IAHCSMM document, contact AAMI at
Byron J. Lambert, PhD, Abbott Laboratories
+1-877-249-8226 or visit
Colleen Patricia Landers, RN, Canadian Standards www.aami.org.
Association
Lisa N. Macdonald, Becton Dickinson & Company
Jeff Martin, Alcon Laboratories Inc.
Patrick J. McCormick, PhD, Bausch & Lomb Inc.
Rainer Newman, Johnson & Johnson
Janet M. Prust, 3M Healthcare
Nancy Rakiewicz, Moog Medical Devices
Michael H. Scholla, Dupont Protection Technologies
Mark Seybold, Baxter Healthcare Corporation
Andrew Sharavara, PhD, Propper Manufacturing Co Inc.
Mark N. Smith, Getinge USA
William N. Thompson, Covidien
Martell Kress Winters, BS SM, Nelson Laboratories Inc.
William E. Young, (Independent Expert)
Alternates: Lloyd Brown, Covidien
Glenn W. Calvert, Becton Dickinson & Company
Steven J. Elliott, WuXi AppTec Inc.
Thomas J. Frazar, Johnson & Johnson
Kathy Hoffman, Sterigenics International
Jim Kaiser, Bausch & Lomb Inc.
Natalie Lind, IAHCSMM
vi © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

Reynaldo Lopez, Cardinal Health (MP&S)

Ralph Makinen, Boston Scientific Corporation
Mary S. Mayo, CR Bard
David Ford McGoldrick, BS, Abbott Laboratories
Jim Neher, NAMSA
Jerry R. Nelson, PhD, Nelson Laboratories Inc.
Karen Polkinghorne, Dupont Protection Technologies
Wallace E. Puckett, PhD, Steris Corporation
Mike Sadowski, Baxter Healthcare Corporation
Jason Voisinet, Moog Medical Devices
Craig A. Wallace, 3M Healthcare
Valerie Welter, Hospira Worldwide Inc.
NOTE--Participation by federal agency representatives in the development of this document does not constitute
endorsement by the federal government or any of its agencies.
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© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 vii
Foreword
This standard was developed by the AAMI Reusable Sterilization Container Working Group under the auspices of the
AAMI Sterilization Standards Committee. The objective of this standard is to provide minimum labeling, safety,
performance, and testing requirements to help ensure a reasonable level of safety and efficacy in rigid sterilization
containers and instrument organizers, which are referred to in this standard as containment devices for reusable
medical device sterilization.
This standard is the second edition of Containment devices for reusable medical device sterilization, which was first
published as an American National Standard in 2006 as ANSI/AAMI ST77:2006. In comparison to the first edition,
this new edition includes an informative annex on integrating medical devices with rigid sterilization container
systems.
Compliance with this standard is voluntary. The existence of the standard does not preclude anyone from
manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard.
As used within the context of this document, “shall” indicates requirements strictly to be followed in order to conform
to the standard; “should” indicates that among several possibilities one is recommended as particularly suitable,
without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or
that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is
used to indicate that a course of action is permissible within the limits of the standard; and “can” is used as a
statement of possibility and capability. “Must” is used only to describe “unavoidable” situations, including those
mandated by government regulation.
This standard should be considered flexible and dynamic. As technology advances and as new data are brought
forward, the standard will be reviewed and, if necessary, revised. Suggestions for improving this standard are invited.
Comments and suggested revisions should be sent to Technical Programs, AAMI, 4301 N. Fairfax Drive, Suite 301,
Arlington, VA 22203-1633.
NOTE—This foreword does not contain provisions of the American National Standard Containment devices for reusable
medical device sterilization (ANSI/AAMI ST77:2013), but it does provide important information about the development
and intended use of the document.
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viii © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013
American National Standard ANSI/AAMI ST77:2013/(R)2018
Containment devices for reusable medical device

sterilization
Introduction
Containment devices for reusable medical device sterilization comprise a number of different types of systems,
including reusable rigid sterilization containers and instrument organizers. Containment devices are intended to serve
as packaging for instruments and other medical devices before, during, and after sterilization of the instruments and
devices. Furthermore, such systems can be designed as an aid to the efficiency of the surgical procedure. Instrument
organizers with lid and base serve to secure and organize instrument sets and other medical devices within a sealed
reusable rigid sterilization container or within a legally marketed sterilization wrap. Reusable rigid sterilization
containers require a barrier system (e.g., filters or valves) to maintain the integrity of the package. Reusable rigid
sterilization containers and instrument organizers vary in their design, the mechanics of operation, and the materials
of construction.
1
Although AAMI has published recommended practices (ANSI/AAMI ST79 and ANSI/AAMI ST41 ) that contain
guidance for users of reusable rigid sterilization container systems, ANSI/AAMI ST79 and ANSI/AAMI ST41 are not
device standards. These recommended practices do outline in a broad format the information that the manufacturer
should supply the user to demonstrate that a reusable rigid sterilization container system has been qualified in
commonly available hospital cycles. However, they do not establish performance requirements for reusable rigid
sterilization container systems or other containment devices such as instrument organizers. Therefore, a design and
performance standard for containment devices, ANSI/AAMI ST77, was developed to provide manufacturer
requirements. These requirements entail labeling, sterilization effectiveness (e.g., sterilant penetration, air removal),
sterilant compatibility, sterility maintenance (barrier properties), compatibility with the intended use (e.g., containment
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for sterilization of endoscopes, implants, and other devices), maximum size, maximum load, and validation of
performance (including accessories) in specific sterilization cycles.
There are two primary categories of containment devices: (a) self-contained reusable rigid sterilization containers that
This
require a barrier is a(e.g.,
system preview
filters oredition of (b)
valves), and ancontainment
AAMI guidance devices thatdocument and iswrap or pouch
require a sterilization
to maintain sterile integrity once the containment device and its contents are sterilized. Containment device and
packaging manufacturers bear the ultimate responsibility for validating that their products are compatible with a
specified sterilizationof the document
method. beforebear
Health care personnel making a purchasing
the ultimate decision.
responsibility for using the containment device
or packaging material in the recommended sterilization method and for performing tests to ensure that items to be
packaged can be For a complete
sterilized copysterilizers
by the specific of thisandAAMI document,
sterilization contact
methods used AAMI
within the healthatcare facility.
1 Scope +1-877-249-8226 or visit www.aami.org.
1.1 General
This standard applies to containment devices intended for use in sterilizing reusable medical devices in health care
facilities.
NOTE—For purposes of this standard, “health care facilities” means hospitals, nursing homes, extended-care facilities, free-
standing surgical centers, clinics, and medical and dental offices. For convenience, the term “hospital” is sometimes used in this
recommended practice; in all instances, this term should be taken to encompass all other health care facilities.
1
Guidance for the use of reusable rigid sterilization container systems was originally provided in ANSI/AAMI ST33, Guidelines for
the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health
care facilities. The provisions of this document pertaining to sterilization container systems intended for use in steam sterilization
were updated and incorporated into ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health
care facilities. The provisions of ANSI/AAMI ST33 pertaining to sterilization container systems intended for use in ethylene oxide
sterilization were updated and incorporated into the latest edition of ANSI/AAMI ST41, Ethylene oxide sterilization in health care
facilities: Safety and effectiveness.
© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 1

1.2 Inclusions
This standard covers the design, performance, and labeling criteria for reusable rigid sterilization containers and
instrument organizers intended for use in health care facilities for the purpose of containing reusable medical devices
for sterilization. Definitions of terms, normative references, and informative annexes are also included, as well as the
rationale and relevant test methods for the provisions of the standard.
1.3 Exclusions
This standard does not cover the selection and use of containment devices by health care personnel.
NOTE—Guidelines for the selection and use of reusable rigid sterilization container systems in health care facilities are provided in
ANSI/AAMI ST79 and ANSI/AAMI ST41.
This standard does not describe the use (including re-use) of packaging materials and systems to contain a
contaminated medical device during transportation of the item to the site of reprocessing or disposal.
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2 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not
apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of
applying the most recent editions of the normative documents indicated below. For undated references, the latest
edition of the normative document referred to applies. AAMI maintains a register of currently valid AAMI technical
documents.
2.1 Association for the Advancement of Medical Instrumentation. Sterilization of health care products—
Biological indicators—Part 1: General requirements. ANSI/AAMI/ISO 11138-1:2006/(R)2010. Arlington (VA): AAMI,
2010. American National Standard.
2.2 Association for the Advancement of Medical Instrumentation. Sterilization of health care products—Chemical
indicators—Part 1: General requirements. ANSI/AAMI/ISO 11140-1:2005/(R)2010. Arlington (VA): AAMI, 2010.
American National Standard.
2.3 Association for the Advancement of Medical Instrumentation. Sterilization of medical devices—Information to
be provided by the manufacturer for the processing of resterilizable medical devices. ANSI/AAMI ST81:2004/(R)
2010. Arlington (VA): AAMI, 2010. American National Standard.
2.4 Association for the Advancement of Medical Instrumentation. Biological evaluation of medical devices—Part
1: Evaluation and testing within a risk management process. ANSI/AAMI/ISO 10993-1:2009. Arlington (VA): AAMI,
2009. American National Standard.
2.5 Association for the Advancement of Medical Instrumentation. Biological evaluation of medical devices—Part
7: Ethylene oxide sterilization residuals. ANSI/AAMI/ISO 10993-7:2008/(R)2012. Arlington (VA): AAMI, 2008.
2.6 United States Pharmacopeial Convention. The United States Pharmacopeia and National Formulary.
(Current edition.) Rockville (MD): United States Pharmacopeial Convention Inc. Sterility tests.
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3 Definitions and abbreviations
For the purpose of this standard, the following definitions apply.
3.1 aseptic presentation: Maintaining the sterility of the contents as a sterilized package is opened and the
contents are removed.
3.2 biological indicator (BI): Test system containing viable microorganisms providing a defined resistance to
the specified sterilization process. (See ANSI/AAMI/ISO 11138-1.)
NOTE 1—According to FDA, "a biological sterilization process indicator is a device intended for use by a health care provider to
accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists
of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a
protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of
sterilization." [21 CFR 880.2800(a)(1)]
NOTE 2—Biological indicators are intended to demonstrate whether or not the conditions were adequate to achieve sterilization. A
negative BI does not prove that all items in the load are sterile or that they were not all exposed to adequate sterilization conditions.
NOTE 3—See ANSI/AAMI/ISO 14161 for information on the selection, use, and interpretation of biological indicators.
3.3 chemical indicator (CI): Devices used to monitor the presence or attainment of one or more of the
parameters required for a satisfactory sterilization process, or used in specific tests of sterilization equipment. (See
ANSI/AAMI/ISO 11140-1)
3.4 container, reusable rigid sterilization: Sterilization containment device designed to hold medical devices
for sterilization, storage, transportation, and aseptic presentation of contents.
NOTE—The system generally consists of a bottom or base with carrying handles and a lid that is secured to the base by means of a
latching mechanism. A basket or tray to hold instruments or other items to be sterilized is placed inside. A filter or valve system is
incorporated into the lid and/or base to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as
a barrier to microorganisms during storage, handling, and transport.
3.5 containment device: Reusable rigid sterilization container, instrument organizer, and any reusable
accessories intended for use in health care facilities for the purpose of containing reusable medical devices for
sterilization.
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NOTE—Although containment devices are primarily intended to contain reusable medical devices for sterilization, they may also
contain nonsterile devices intended for one-time use after sterilization.
3.6 This isPeriod

cool-down: a preview edition
of time after of an AAMI
steam sterilization duringguidance document
which containment devices and is to cool on
are allowed
intended
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sterilizer potential
handling.purchasers to evaluate the content
NOTE—The time allowed of for
the document
cool-down before
should take making
into account a purchasing
the sterilizer decision.
being used, the design of the device being sterilized,
the temperature and humidity of the ambient environment, and the type of containment device and/or wrap used, or the user should
For
be instructed that the aload
complete copyfollowing
may be released of thisdirect,
temperature has reached ambient (room) temperature.
AAMI document,
non-contact contact
measurement AAMI atshowing that the
of its temperature

3.7 cycle: Defined sequence of operational steps designed to achieve sterilization and carried out in a sealed
chamber.
3.8 cycle, ethylene oxide: Type of gaseous chemical sterilization cycle in which the four process variables are
ethylene oxide (EO) gas concentration, exposure time, temperature, and relative humidity.
3.9 cycle, hydrogen peroxide gas with plasma: Type of gaseous chemical sterilization cycle in which the four
process variables are hydrogen peroxide concentration, time, temperature, and gas plasma power level.
3.10 cycle, hydrogen peroxide gas without plasma: Type of gaseous chemical sterilization cycle in which the
three process variables are hydrogen peroxide concentration, time, and temperature.
3.11 cycle, ozone sterilization: Type of gaseous chemical sterilization cycle in which the four process variables
are ozone dose injected, humidity, exposure time, and temperature.
3.12 cycle, steam sterilization, dynamic-air-removal type: One of two types of sterilization cycles in which air
is removed from the chamber and the load by means of a series of pressure and vacuum excursions (prevacuum
cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush
pressure-pulse [SFPP] cycle).

NOTE 1—In prevacuum steam sterilizers, the dynamic-air-removal cycle depends upon one or more pressure and vacuum
excursions at the beginning of the cycle to remove air. This method of operation results in shorter cycle times for packaged items
because of the rapid removal of air from the chamber and the load by the vacuum system and because of the usually higher
operating temperatures (132 °C to 135 °C [270 °F to 275 °F]). This type of cycle generally provides for shorter exposure times and
accelerated drying of fabric loads by pulling a further vacuum at the end of the sterilizing cycle.
Note 2—In steam-flush pressure-pulse steam sterilizers, the dynamic-air-removal cycle depends upon a repeated sequence
consisting of a steam flush and a pressure pulse to remove air from the sterilizing chamber and processed materials. As is the case
with prevacuum sterilizers, the dynamic-air-removal cycle of a steam-flush pressure-pulse sterilizer rapidly removes air from the
sterilizing chamber and wrapped items. Air removal is achieved with the sterilizing chamber pressure at above atmospheric pressure
(no vacuum is required to remove air for sterilization). Typical operating temperatures are 132 °C to 135 °C (270 °F to 275 °F).
3.13 cycle, steam sterilization, gravity-displacement type: Type of sterilization cycle in which incoming steam
displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber.
NOTE—Typical operating temperatures are 121 °C to 123 °C (250 °F to 254 °F) and 132 °C to 135 °C (270 °F to 275 °F).
3.14 D value: Time or dose required to achieve inactivation of 90% of a population of a test microorganism under
stated conditions.
3.15 drying time: Time required to dry steam-sterilized items inside the sterilizer.
3.16 exposure time: Period for which the process parameters are maintained within their specified tolerances.
3.17 filter, container: Device secured to the rigid sterilization container system lid and/or bottom that serves to
allow passage of air and sterilants yet provides a microbial barrier.
NOTE—The filter media could be reusable, disposable, or permanently affixed to the container.
3.18 filter retention system, container: Mechanism that secures filters in place.
NOTE—The filter retention system could be a retention plate or a retaining ring. It is disengaged to release used filters for disposal
and reengaged to secure new filters.
3.19 gasket, container: Pliable strip that serves as a seal between the lid and the base of a reusable rigid
sterilization container to prevent entry of contaminants.
3.20
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immediate-use steam sterilization: Process designed for the cleaning, steam sterilization, and delivery of
patient care items for immediate use. Previously known as flash sterilization. See also ANSI/AAMI ST79.
3.21 instructions
This is for use (IFU): Written
a preview edition of an AAMI
instructions providedguidance
by the devicedocument
manufacturerand is users on the
to direct
care, maintenance, reprocessing, and use of a device.
3.22 insert case or tray: Reusable case or tray that is placed inside a reusable rigid sterilization container, that
is fixed or not fixed in place, and that serves to group or protect instruments and components.
3.23 For aorganizer:

instrument complete copy of
Reusable this
metal or AAMI document,
plastic containment contact
device, AAMIincluding
sometimes at a rack or
cassette, that organizes and protects instruments and components in specified locations within the device, and that is
usually packaged with an approved material.
3.24 latching mechanism, container: Mechanical device that secures the lid of a reusable rigid sterilization
container system to the bottom of the container.
3.25 load: Similar items requiring the same sterilization parameters that are sterilized together.
NOTE—The load configuration should ensure adequate air removal, penetration of the sterilant into each containment device, and
sterilant evacuation.
3.26 polyolefin: Family of polymers made from olefin monomers and including polypropylene, polyethylene, and
polyisoprene.
3.27 reusable accessory: Optional component not essential in itself but that aids in the organization and
protection of instruments within a sterilization container system. Such items include, but are not limited to, insert
cases, instrument organizers, cassettes, brackets, posts, partitions, instrument mats, racks, and stringers.
3.28 stacked: Sterilization containers placed directly on top of one another, without separation between them.
3.29 steam quality: Steam characteristic reflecting the dryness fraction (weight of dry steam present in a mixture
of dry saturated steam and entrained water), the level of noncondensable gas (air or other gas that will not condense

under the conditions of temperature and pressure used during the sterilization process), and the degree of superheat.
See also ANSI/AAMI ST79.
3.30 sterile barrier system: Minimum packaging configuration that maintains sterility of the package contents
until aseptic presentation at the point of use.
3.31 sterility assurance level (SAL): Probability of a single viable microorganism occurring on an item after
sterilization.
NOTE 1—SAL is normally expressed as 10-n.
NOTE 2—An SAL of 10-6 means that there is less than or equal to one chance in a million that a single viable microorganism is
present on a sterilized item. It is generally accepted that an SAL of 10-6 is appropriate for items intended to come into contact with
compromised tissue (that is, tissue that has lost the integrity of the natural body barriers).
3.32 sterilizer: Apparatus used to sterilize medical devices, equipment, and supplies by direct exposure to the
sterilizing agent.
3.33 sterilizer, ethylene oxide: Sterilizer that utilizes EO under defined conditions of gas concentration,
temperature, time, and percent relative humidity.
3.34 sterilizer, hydrogen peroxide gas with plasma: Sterilizer that uses a multiphase sterilization process
combining exposure to hydrogen peroxide and to gas plasma to effect sterilization.
3.35 sterilizer, hydrogen peroxide gas without plasma: Sterilizer that uses vaporized hydrogen peroxide as
the sterilizing agent.
3.36 sterilizer, ozone: Sterilizer that uses ozone as the sterilizing agent.
3.37 sterilizer, steam: Sterilizer that uses saturated steam under pressure as the sterilizing agent.
3.38 tamper-evident closure system: Seal or disposable “lock” that is generally secured on the container
latching mechanism and that indicates whether the container has been opened.
NOTE—A tamper-evident device is designed so that it cannot be resealed after opening. It is intended to indicate that the container
has not been opened intentionally or accidentally and therefore exposed to potential contamination before use.
3.39 PREVIEW COPY

tray: Basket, with or without a lid, that has perforated sides or bottom, that holds instruments, and that is
either enclosed in sterilization wrap or a pouch or placed inside a container for sterilization.
3.40 user This is a preview

verification: edition
Documented of anperformed
procedures, AAMI guidance documentforand
in the user environment, is recording,
obtaining,
intended
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3.41 validation:of the document

Documented procedurebefore making
for obtaining, a purchasing
recording and interpretingdecision.
the results required to establish
that a process will consistently yield product complying with predetermined specifications.
3.42
valve, container: Mechanical device that opens during sterilization to allow air evacuation and sterilant
+1-877-249-8226
penetration and closes after sterilization or visit www.aami.org.
to prevent contamination.
3.43 volume-to-vent (V-to-V) ratio: Ratio (V-to-V) of the interior container volume to the surface perforation
area.

4 Requirements
4.1 General
The containment device shall permit safe and effective execution of the specific sterilization methods and cycles for
which it is designed and recommended. These cycles shall include the sterilization cycles commonly available in
health care facilities. Its use shall not cause damage to items contained within or limit the efficacy of the sterilization
process in sterilizing those items. The performance of the containment device as it relates to sterilization, drying,
sterilant residual removal, and sterility maintenance shall be tested and documented. The containment device shall
be appropriately labeled and be accompanied by manufacturer's written instructions for use (IFU).
The manufacturer shall provide summary documentation, upon request of the user, of the methodology and results of
the performance testing of the containment system.
4.2 Materials of construction
4.2.1 Durability
The materials used to construct containment devices and, if applicable, reusable accessories recommended for the
cleaning and sterilization method shall not deteriorate (crack, flake, peel, fracture, become brittle, or deform) within
the manufacturer’s recommended useful life at the maximum sterilization conditions recommended by the
manufacturer. The manufacturer shall determine if processing in accordance with the provided written IFU can lead to
a degree of degradation that will limit the useful life of the containment device; in this case, the manufacturer shall
provide a recommended inspection protocol that will enable the user to identify the end of the containment device’s
ability to fulfill its intended use.
Rationale: Containment devices can be manufactured from a variety of materials, including metal, plastic, and
composite materials; those constructed from a mixture of these materials (e.g., metals, plastics, and/or composites)
are referred to as “hybrid.” These materials should be durable and appropriate for the cleaning and sterilization
method recommended because containment devices are intended for multiple uses and multiple reprocessing.
4.2.2 Compatibility with the sterilization process
The materials of construction shall not inhibit or interfere with the sterilization and drying process for which the
containment device is recommended.
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Rationale: Some materials are not compatible with certain sterilization processes.
4.2.3 Corrosion resistance

Metal materialsintended to allow
used to construct potential
containment purchasers
devices tocorrosion-resistant
shall either be evaluate the content
or be treated to improve
their corrosion resistance.
Rationale: Many metals rust, pit, discolor, or corrode when repeatedly exposed to detergents, sterilizing agents, and
For a complete
condensation, especially copy of this
at elevated temperatures andAAMI document,
in the presence contact
of chemical agents.AAMI at
4.2.4 Biocompatibility +1-877-249-8226 or visit www.aami.org.
Following exposure to the recommended sterilization process, materials used to construct containment devices shall
not adversely affect the biocompatibility of devices processed within the containment device, as defined by the
appropriate standards of the ISO 10993 series and using the worst-case sterilization load configuration within the
containment device and the worst-case processing parameters.
Rationale: The materials of construction of containment devices do not contact a patient’s body directly. However,
these materials could potentially, through migration, flaking, or leaching, indirectly transfer toxic chemicals or particles
to devices being sterilized.
4.3 Design
4.3.1 General
The configuration of the containment device shall accommodate the proper arrangement of the medical devices to be
processed for inspection, sterilization, sterilant removal, and storage. Containment devices intended to be used with
sterile barrier systems shall be designed to be compatible with those systems.
Rationale: The main purposes of a containment device are to organize, permit sterilization of and sterilant removal
from, protect, and safely store the instrumentation within. Appropriate arrangement of medical devices provides
assurance that they will be exposed to the sterilant.

Another purpose of some containment devices is to maintain the sterility of the contents after sterilization until
delivery to and aseptic presentation at the point of use. With respect to containment devices using sterilization wrap,
for example, sharp edges or points of puncture, such as feet or corners, can potentially cause a breach of this sterile
barrier system.
4.3.2 Decontamination
Containment devices shall allow for decontamination of the containment device itself and its reusable accessories by
means of either a manual or automated method. If reusable accessories are intended by the manufacturer to allow for
decontamination of specific instrumentation within the accessory, then the accessory shall be validated for this
purpose, and appropriate written IFU shall be provided to the user.
Manufacturers of containment devices that are not treated or minimally treated for corrosion resistance should state
in their labeling and IFU in detail how to properly clean and decontaminate such devices using a manual or
automated method after each use.
Rationale: Decontamination of the containment device and its reusable accessories is essential for sterilization. Most
containment devices and reusable accessories are not designed to allow decontamination of their contents in situ.
However, if the containment device or reusable accessory is intended and labeled for this purpose, validation is
essential to ensuring that instrumentation can be adequately decontaminated in this manner.
4.3.3 Perforations
The perforations in the containment device shall permit the sterilant to enter into and be removed from the
containment device. The size and number of perforations shall be sufficient to support the sterilization and drying
processes for which the containment device is labeled.
Rationale: The size and number of perforations can affect the efficiency of air removal, sterilant penetration and
evacuation, and drying in the containment device.
4.3.4 Stacking
4.3.4.1 Internal stacking
Internal stacking refers to two or more layers within a containment device.
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If instrument organizers are to be stacked within a containment device, the following factors shall be addressed for
each sterilization method for which stacking is recommended:
a) ease This is a of
of removal preview edition
stacked items within of an AAMIdevice;
a containment guidance document and is
b)
the maximum density of contents within the containment device to allow for proper sterilization and drying;
c) adequate perforations to allow for sterilant penetration, sterilant evacuation, drying, and, if applicable,
aeration;
d) +1-877-249-8226
the stability of the stacked or and
items during transport visit www.aami.org.
handling;
e) a dry outcome (see 4.4.2.1);
f) achievement of sterilization throughout the layers of stacked instrument organizers and the recommended
accessories (e.g., mats, holders) within the containment device. If any of the accessories are not compatible
with a specific sterilization method, the incompatibility should be indicated in the written IFU.
4.3.4.2 External stacking
External stacking refers to rigid sterilization container systems stacked one on top of another during the sterilization
process, transportation, or storage.
If rigid sterilization container systems are to be stacked during the sterilization process, the following factors shall be
addressed for each sterilization method for which stacking is recommended:
a) The sterilant can adequately penetrate each of the stacked rigid sterilization container systems and any
reusable accessories of the rigid sterilization container systems and achieve sterilization of the enclosed
medical devices.
b) Air should not be trapped within the rigid sterilization container systems during the sterilization process, and
condensation should not be present inside or outside of the rigid sterilization container systems after the
sterilization process.

NOTE—If air becomes trapped within a rigid sterilization container system, the sterilant cannot reach all areas. This issue
might not apply to medical devices sterilized by dry heat, provided that it can be validated that sterilization occurs in areas
where air could be trapped.
c) The stacked devices are stable and will not shift during the sterilization process.
d) The stacked rigid sterilization container systems can be removed from the sterilizer without compromising
the sterile barrier of either the rigid sterilization container systems being removed or the rigid sterilization
container system(s) adjacent to the device being removed.
If rigid container systems are intended to be stacked during storage or transport, the stability of the stacked
configuration shall be ensured.
4.3.5 Maximum weight
The combined weight of the containment device, the instruments, and any accessories or wrappers shall not exceed
25 pounds when the containment device load is configured according to the manufacturer’s written IFU.
Rationale: When containment devices, including their contents and any accessories or wrappers, are too heavy,
sterilization and/or drying may be compromised in commonly available hospital sterilization cycles (according to
ANSI/AAMI ST79, drying time is typically 20 to 30 minutes; see also AAMI TIR12 and ANSI/AAMI ST58). Additionally,
there may be ergonomic issues associated with heavy containment devices. A maximum weight limit of 25 pounds
was chosen for several reasons. From an ergonomic standpoint, calculations from the NIOSH equation on manual
lifting (Waters et al., 1994) yield recommended weight limits intended to protect workers from injuries due to lifting.
This weight limit is similar to other weight standards in other countries.
The limit of 25 pounds was chosen as the recommended maximum weight for containment devices because of the
aforementioned sterilization and drying considerations and because containment devices and their contents must be
handled extensively and repeatedly by personnel when cleaning and preparing them for sterilization, loading them
into the sterilizer, unloading them from the sterilizer, and storing and distributing them. It should be noted that the
25 pound weight limit assumes that the user follows the manufacturer’s written IFU with respect to contents and
accessories.
4.3.6 Additional requirements for reusable rigid sterilization containers
4.3.6.1 Gaskets
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The interface between the lid and base of a reusable rigid sterilization container shall be sealed using a closure
gasket. The closure interface formed by the gasket shall provide a microbial barrier. The gasket shall be accessible
and cleanable.ThisSignsisofawear
preview edition
or damage of anshall
to the gasket AAMI guidance
be readily document
detectable. and is
The manufacturer shall specify the
intended
useful life of the gasket. to allow potential purchasers to evaluate the content
of thethe
In accordance with 4.5.2(h), document before
manufacturer making
shall provide a purchasing
a routine decision.
maintenance and inspection schedule to ensure
that barrier properties remain intact.
Rationale: The gasket interface should provide a microbial barrier in order to prevent recontamination of the
+1-877-249-8226
containment device contents once they are sterilized. Aor visitmaintenance
routine www.aami.org.
and inspection schedule is necessary to
ensure that the microbial barrier remains intact. Signs of wear or damage to the gasket should be readily detectable
so that the user can ensure that it remains functional as a microbial barrier.
4.3.6.2 Filters
The filters of reusable rigid sterilization containers shall completely cover the sterilization port(s). The means by which
the filter is held in place shall provide a tight uniform seal.
Filters shall be protected to prevent tears and potential damage. The filters and filter retention mechanisms shall
provide a microbial barrier. Compatibility of the filter with the specified sterilization modality shall be demonstrated.
For reusable filters, the manufacturer shall specify the filter’s useful life, which has been documented in reuse testing.
In accordance with 4.5.2(h), the manufacturer shall provide a routine maintenance schedule and inspection criteria to
ensure that barrier properties remain intact, along with decontamination and handling instructions (e.g., whether it is
necessary to remove the reusable filter material from the sealed containment device for cleaning). The manufacturer
shall specify in the written IFU the frequency with which the reusable filter should be cleaned (e.g., after each use),
the cleaning process, the type of detergent, the compatibility of cleaning agents, and a method of tracking the number
of uses.
Rationale: The filters and filter retention mechanisms should provide a microbial barrier in order to prevent
recontamination of the containment device contents once they are sterilized.

4.3.6.3 Valves (if applicable)
Valves shall open to allow for sterilization and close properly to provide a microbial barrier to their defined limits of
reuse.
Mechanical valves shall be readily cleanable. Signs of wear or damage to valves shall be readily detectable. The
manufacturer shall specify the valve's useful life, which has been validated in reuse testing. The manufacturer shall
specify the instructions for access for cleaning.
Rationale: Valves should provide a microbial barrier throughout their useful life in order to prevent recontamination of
the containment device contents once they are sterilized. Damage to valves should be detectable so that the user
can ensure that the valves remain functional as a microbial barrier.
4.3.6.4 Handles
Each reusable rigid sterilization container shall be provided with adequate carrying handles. These handles shall
a) be positioned to provide and maintain the stability of the containment device under the worst-case center-of-
gravity loading conditions recommended by the manufacturer;
b) be designed to carry a minimum of four times the maximum recommended weight of the fully loaded
container system (as specified in 4.3.5) without deforming, cracking, or exhibiting other evidence of damage;
c) have no sharp edges; and
d) permit opening of the container and removal of the sterile contents without compromising aseptic
presentation of the contents.
Rationale: It is important for the handles of reusable rigid sterilization containers to be designed to allow effective
transportation and storage and safe handling by users. The ergonomic design of reusable rigid sterilization container
systems helps ensure that users can handle them without injury. The safety factor specified in subparagraph b) is
consistent with the requirements of UL 61010A-1 and CSA C22.2 No. 601.1-M90.
4.3.6.5 Lid-base compatibility
Lids and bases of reusable rigid sterilization containers shall be designed so that lids of the same model and size are
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interchangeable throughout the useful life.
Rationale: It is important for the lids and bases of the same model and size of reusable rigid sterilization containers to
be compatibleThis is amixing
so that preview edition of
of components will an
notAAMI guidance
affect the integrity ofdocument anddevice
the containment is and thus
compromise sterility maintenance.
4.3.6.6 Latching mechanisms
Latching mechanisms shall secure the lid so that it cannot be displaced when locked and shall draw down the gasket
For
for a secure seal. a complete
In addition, latchingcopy of this
mechanisms AAMI document, contact AAMI at
shall
a) +1-877-249-8226
be cleanable and accessible; or visit www.aami.org.
b) be capable of being checked for signs of proper function and for signs of wear or damage;
c) have no sharp edges;
d) be capable of holding the seal; and
e) permit opening of the reusable rigid sterilization container without compromising aseptic presentation of the
sterile contents.
Rationale: Latching mechanisms ensure a secure gasket seal as part of the microbial barrier.
4.3.6.7 Tamper-evident system
The tamper-evident closure system shall provide a clear indication that the reusable rigid sterilization container has
been opened and the microbial barrier compromised.
If a chemical indicator (CI) is provided, it shall comply with ANSI/AAMI/ISO 11140-1.

NOTE—Tamper-evident closures and sterilization indicators might not be the same device.

Rationale: Tamper-evident closures provide the user with visual verification that the container has not been opened
after sterilization until the time of use.
4.4 Performance
4.4.1 Sterilization
4.4.1.1 General Requirements
The containment device shall be specified for use with one or more of the sterilization processes and cycles
commonly available in health care facilities, including immediate-use steam sterilization (see AAMI TIR12,
ANSI/AAMI ST79, ANSI/AAMI ST41, and ANSI/AAMI ST58). Exposure time and/or drying time may be extended if
shown to be necessary in validation studies (see also 4.5.2) and there are compatible FDA-cleared BI(s), CI(s), and
packaging material(s).
Specific recommendations shall be made, in the manufacturer’s written IFU (see 4.5.2), regarding the type,
placement, internal stacking (if applicable), loading of items in the containment device (including instruments to be
sterilized and reusable accessories), and, if required, the appropriate cool down period after load removal and when
the containment device can be "touched" for each different sterilization process. If weight, size, or other limitations of
items affect sterilization efficacy within the containment device, the limitations shall be clearly stated. If the number or
orientation of containment devices within the sterilization chamber affect sterilization efficacy, the limitations shall be
clearly stated.
NOTE—The burn threshold for 10 minutes of contact time has been quantified at 48 °C (118 °F) (CENELEC 2007).
The manufacturer shall demonstrate that the contents of the containment device can be processed to a sterility
-6
assurance level (SAL) of 10 under the conditions of intended use.
NOTE—The manufacturer may claim equivalence if the item is equally or less challenging than a previously validated item.
Rationale: Containment devices should be validated for sterilization efficacy (sterilant penetration and, if applicable,
air removal). All efforts should be made to use sterilization cycles commonly available in health care facilities because
a) health care facilities generally do not have the ability to independently validate sterilization parameters;
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b) sterilizers in some health care facilities do not allow the operator to change the sterilization parameters;
c) BIs commercially available to health care facilities are FDA-cleared and designed to monitor commonly
available hospital sterilization cycles; and
d) manufacturers of sterile barrier system material typically test their products in commonly available
intended
sterilization cycles;to allow
if the potential
manufacturer’s purchasers
written IFU calls forto evaluate
increasing the content
the exposure time or drying time of
of material
the cycle, this the document before
could deteriorate making
and lose a purchasing
its barrier properties. decision.
If not properly designed for their intended use, containment devices could inhibit sterilant penetration and/or air
Forprevent
removal and thus a complete copy of this
adequate sterilization AAMI
of their document,
contents, contact
especially in the case of AAMI at with lumens or
instruments
other complexities of design. +1-877-249-8226 or visit www.aami.org.
4.4.1.2 Reconfiguration and combining of cases and sets
Any reconfiguration or combining of cases needs to be assessed based on existing claims, product family, weight,
materials of construction, and load distribution. Where the reconfiguration is equal to or less challenging than the
existing claims, verification is recommended before the product can be placed into service. Where the reconfiguration
exceeds the existing claims, validation testing is recommended before the reconfigured or combined product is put
into service.
4.4.1.3 Documentation
Summary documentation of the test methodology and results shall include information verifying that the sterilization
efficacy of the containment device has been validated for each method of sterilization for which the containment
device is labeled. At least the following information shall be collected by the manufacturer and made available to the
user upon request:
a) the manufacturers, model numbers, and parameters (e.g., pressures, temperatures, number of pulses, time
intervals) of the sterilizers used in testing. In prevacuum steam sterilizers, the dynamic-air-removal cycle
depends upon one or more pressure and vacuum excursions at the beginning of the cycle to remove air.
This method of operation results in shorter cycle times for packaged items because of the rapid removal of
air from the chamber and the load by the vacuum system and because of the usually higher operating

temperatures (132 °C to 135 °C [270 °F to 275 °F]). This type of cycle generally provides for shorter
exposure times and accelerated drying of fabric loads by pulling a further vacuum at the end of the sterilizing
cycle. Since air removal is dependent upon the number and evacuation depth of the pulses, container
manufacturers should specify, in detail, the prevacuum cycle conditions under which their products were
validated;
b) if applicable, the types, sizes, and placement of filters or valve assemblies in the containment device;
c) the weight, density, and distribution of the contents of the containment device (e.g., the separation of the
contents into layered baskets or other accessories);
d) the type, placement, and rationale for the use of any inner wrapping, reusable accessories (e.g., mats,
holders), or absorbent materials included in the contents that could affect sterilization and, if applicable,
drying or EO aeration;
e) the types, number, placement sites, and performance characteristics (e.g., D value) of the BIs and, if
applicable, CIs used for validation of cycle processing;
f) the methodology used for retrieving and culturing BIs and the results;
g) if applicable, the method(s) used to inoculate devices with liquid spore suspensions, the types of devices
used for inoculation, and the recovery methods and controls used;
h) if a sterile barrier system is necessary, the type and size used in the validation;
i) if applicable, the results of chemical monitoring;
j) the sterilizer load configuration;
k) if applicable, load preheating time prior to cycle start (if the load was preheated during testing and if
preheating is recommended to diminish the formation of condensate during the sterilization cycle);
l) if applicable, the methodology used to obtain sterilization process variable profiles of the containment device
and its contents during the sterilization cycle (e.g., use and placement of thermocouples inside the
containment device);
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m) any other factors that influence the sterilization time required for each type of sterilization cycle for which the
containment device is recommended.
4.4.2 This
Drying is a preview
(if applicable) edition of an AAMI guidance document and is
4.4.2.1 intended to allow
*HQHUDORequirements potential purchasers to evaluate the content
The design of containment devices intended for use in steam sterilization shall provide for adequate drying of
contents in commonly available hospital sterilization cycles. After load removal, a cool down time period, if required,
For afor
should be determined complete copydevice.
the containment of this AAMI document, contact AAMI at
Rationale: For a terminal sterilization process, there should be no visible condensed moisture present in or on a
containment device following any sterilization process because of the potential for recontamination. Condensed
moisture may create a pathway for microorganisms to enter the containment device and recontaminate the
instruments inside.
Summary documentation of the test methodology and results shall include at least the following information:
a) if applicable, the vacuum rate and depth achieved during the drying phase of the cycle;
b) the minimum time for the drying phase;
c) the factors that can influence the drying time of the containment device and its contents, such as the
following:
• the materials of construction of the containment device;
• the total mass and distribution of the contents of the containment device;
• the type of wrapping material (material, thickness, and porosity), if applicable;

• the number of containment devices in the load;
• the temperature of the containment device and the contents at the beginning of each test;
• the steam quality;
• the environmental conditions (temperature, relative humidity, air exchange rate) of the cool-down area;
• the duration of cool-down between the time the containment device was removed from the sterilizer and
the time it was opened to determine the dryness of the contents and inner container surfaces;
• the use of any inner wrapping, absorbent materials, or protective devices (e.g., silicone mats) within the
contents;
• the number and configuration of internally stacked instrument organizers;
• reliable, repeatable sterilizer performance;
d) the methodology used to test and validate the conditions necessary to ensure consistent and effective drying
of the containment device and its contents.
4.4.3 Sterilant residual removal (if applicable)

4.4.3.1 *HQHUDORequirements
Containment devices shall provide for adequate removal of sterilant residuals from sterilized contents after
sterilization according to the recommended conditions. Process conditions (time, temperature, and number of air
exchanges/hour) for effective aeration of the containment device and its contents shall be determined, documented,
and provided in the labeling. The analytical results of all sterilant residual tests conducted on the containment device
and its components shall be documented, including post-sterilization residual levels (which are tested along with an
unsterilized control sample). Residual levels of EO in medical devices sterilized in the containment device shall
comply with ANSI/AAMI/ISO 10993-7.
Rationale: The materials used to construct containment devices can retain or accumulate residuals of the sterilant
and/or byproducts or decomposition products of the sterilant. If not adequately removed by aeration, such residuals
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could be harmful to health care personnel and/or patients. Health care facilities rely on the manufacturer to
demonstrate that EO residuals are reduced to a safe level following EO sterilization. It is important that the
manufacturer establish during the design qualification stage that the materials of construction do not retain excessive
levels of sterilant residuals.
The materials used to construct containment devices can strongly influence the efficiency of, and the time necessary
for, the aeration of an EO-sterilized load. It is important to assess such materials after repeated sterilizations because
of the possibility of of the document
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residualsmaking
over timeaand
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adverse impact on aeration of
sterilized medical devices.
a) residue levels, after repeated cycles, for components and materials of construction;
b) aeration time requirements.
4.4.4 Sterility maintenance
4.4.4.1 *HQHUDORequirements
The sterile barrier system of the containment device shall maintain sterility until the containment device is opened and
the sterile contents are aseptically presented. For that reason, there cannot be any sharp areas on the containment
device that can puncture the sterile barrier(s).
Rationale: Sterility maintenance is generally regarded as event-related rather than time-related. Once sterilized and
removed from the sterilizer, the contents of a containment device must remain sterile until they are used. Handling,
transport, and storage could cause a breach of sterility and render the contents unusable. For reusable rigid
sterilization containers, the filters or valves and gaskets provide this assurance. For other containment devices, the
sterilization wrap, pack, or pouch provide this assurance.

a) the design characteristics of the containment device that limit microbial migration and penetration of
contaminants to the contents (e.g., filters or valves, gaskets, sterilization wrap);
b) the test method employed and the results; and
c) the sterile barrier system(s) used to demonstrate sterility maintenance.
4.5 Labeling requirements
4.5.1 Device markings
Each containment device shall be labeled with
a) the name of the manufacturer or distributor; and
b) the manufacturer’s model designation.

NOTE—A means of traceability (the serial number, lot number, or date of manufacture) should be considered.
If they can be separated, all major independent components (e.g., base and lid) shall be so labeled.
4.5.2 Instructions for use (IFU)
The manufacturer’s written IFU shall comply with ANSI/AAMI ST81 and shall contain at least the following
information:
a) the name and address of the manufacturer;

b) the manufacturer’s model or product family designation;
c) instructions for the safe and effective use of the containment device, including
• safety precautions to be taken during routine use;
• PREVIEW COPY
the methods of sterilization (e.g., steam, hydrogen peroxide, ethylene oxide, ozone) and types of cycles,
including cycle parameters (e.g., steam; dynamic-air-removal; sterilization time, temperature, and dry
time) for which the containment device is designed and recommended; any necessary changes to
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distribution of the containment device and its contents;
• the type of filters or wraps that should be used with the containment device;
• the accessories intended for use in the designated sterilization method or cycle and a list of any
accessories found during validation to be incompatible with the associated sterilization method or cycle;
• if applicable (EO sterilization), the recommended aeration parameters (time, temperature, and number
of air exchanges per hour) necessary to reduce sterilant residuals to a safe level;
NOTE—The containment device manufacturer should instruct the user that if the aeration requirements for a device
being sterilized inside the containment device exceed the aeration requirements for the containment device, the
device manufacturer’s aeration recommendations should be followed.
• instructions on whether the rigid sterilization containers can be stacked and, if so, any constraints (e.g.,
a limitation on the height to which the containment devices may be stacked);
• the most challenging area of the rigid sterilization containers for the placement of internal CIs and BIs
for routine monitoring and product testing;
• the reuse limit of reusable rigid sterilization container valves and filters;

d) instructions for disassembly, cleaning, and reassembly of the containment device, including recommended
cleaning agents and cleaning methods;
e) decontamination methods or chemicals that could be harmful to the containment device;
f) if applicable, instructions for a method of labeling the containment device;
g) information on the general categories of medical devices that the manufacturer has tested in the validation
of the containment device;
h) instructions for inspection and routine maintenance, including
• a schedule for implementing inspection and routine maintenance procedures;
• a caution that these procedures should be carried out by trained personnel;
• specific directions concerning the maintenance of critical components; and
• a recommended inspection protocol that will enable the user to identify the end of the containment
device’s useful life;
i) information regarding authorized service companies in the event that the containment device requires
service or repair.
Rationale: The requirements listed above are intended to help ensure that users of containment devices will be given
sufficient information by the manufacturer to enable them to use these products safely and effectively.
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5 Tests
5.1 General
This section provides test methods and procedures for the critical requirements defined below. The requirements for
compatibility with the sterilization process (4.2.2), perforations (4.3.3), and stacking (4.3.4) shall be determined by the
test methods specified in 5.6 (Sterilization). Unless otherwise specified below, compliance with all other requirements
of Section 4 may be verified by inspection.
NOTE—Other tests may be used if equivalence to the referenced test methods can be demonstrated.
Test apparatus and instruments. Test apparatus and instruments should be calibrated in accordance with the federal
Quality System Regulation (21 CFR 820.72). The quality assurance program establishing the frequency and method
of calibration should be documented.
5.2 Biocompatibility
The choice of test shall take into account the general principles described in ANSI/AAMI/ISO 10993-1 (e.g., the
chemical and physical nature of the material, the toxicological activity of the chemicals forming the final product).
NOTE—Annex B of ANSI/AAMI/ISO 10993-1 provides a bibliography of international standards and guidelines for biological
response testing and USP biological reactivity in vitro test methods.
5.3 Gaskets and filters
Compliance shall be demonstrated by sterilization validation and sterility maintenance testing. For reusable filters,
compliance shall be demonstrated by sterilization validation and sterility maintenance testing at the end of the defined
useful life of the filter.
5.4 Valves
Compliance with the requirement that mechanical valves have a defined limit of reuse shall be verified by sterilization
efficacy testing and sterility maintenance testing at the end of the defined useful life of the valve.
5.5 Handles
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Compliance with the requirements of 4.3.6.4 shall be verified by inspection and by the following test.
A single handle or grip shall be subjected to a force corresponding to four times the maximum design load weight of
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force shall ofuniformly
be applied an AAMI over aguidance
70 millimeterdocument and
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at the
handle or grip, without clamping. The force shall be increased steadily so that the test value is attained after 10
intended
seconds and maintained for to allow potential purchasers to evaluate the content
1 minute.
If more than one handle or grip is fitted, the force shall be distributed between the handles or grips in the same
proportion as in normal use. If the containment device is fitted with more than one handle or grip but is designed so
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The handles or grips shall not break loose from the containment device, and there shall be no permanent distortion,
cracking, or other evidence of failure.
5.6 Sterilization
Sterilization efficacy tests shall be conducted with all methods and cycle parameters for which the containment device
is recommended. These methods and cycle parameters shall be equivalent to those commonly available in health
care facilities (see AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST41, and ANSI/AAMI ST58). Exposure time and/or
drying time may be extended if shown to be necessary in validation studies (see also 4.5.2), but FDA-cleared BIs,
CIs, and accessories may not be available.
-6
Biological testing of containment devices shall demonstrate a sterility assurance level (SAL) of 10 . Depending on
the method of sterilization, testing shall be performed with either half cycles, fractional cycles, or predetermined
increments of critical process parameters of the specified sterilization method (e.g., concentration, volume, time).
Biological indicators that have been determined to be highly resistant to the sterilization method shall be used (see
Table 1).

Table 1—Biological indicators for various sterilization processes
Sterilization process Biological indicator organism/spore

Steam sterilization Geobacillus stearothermophilus (formerly called
Bacillus stearothermophilus)
Dry heat sterilization Bacillus atrophaeus (formerly called Bacillus subtilis
var. niger)
Ethylene oxide sterilization Bacillus atrophaeus (formerly called Bacillus subtilis
var. niger)
Hydrogen peroxide gas plasma sterilization Geobacillus stearothermophilus (formerly called
Hydrogen peroxide vapor phase Geobacillus stearothermophilus (formerly called
Ozone sterilization Geobacillus stearothermophilus (formerly called
Testing shall be conducted using the types of devices for which the containment device is recommended.
Microbiological challenges should be placed in the most difficult-to-sterilize, accessible areas (e.g., lumens, mated
surfaces) of the test devices and, if applicable, at the interface of the test devices with packaging accessories. If it is
not possible to reach these areas with a BI spore strip or other inoculated carrier (e.g., inoculated thread), then the
area may be inoculated with the specified microbiological challenge using a liquid spore suspension.
NOTE—Direct inoculation of a product with a liquid spore suspension can result in variable resistance of the inoculum because of
the occlusion of the spores on or in the product, surface phenomena, and/or other environmental factors. Therefore, it is important to
validate this practice. See Sections A.7 and C.3 of ANSI/AAMI/ISO 11737-1.
Testing shall include containment devices that represent the worst-case challenge to the sterilization process (in
terms of air removal, maximum containment device load, and highest ratio of container volume to surface perforation
area).
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The maximum weight, density, and distribution of the contents of the containment device (e.g., the use of baskets,
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Internal mapping profiles of identified critical parameters inside the containment device, with probes placed in
strategic areas, shall be conducted on full cycles unless it can be demonstrated that adequate sterilant penetration is
achieved within the containment device for a half-cycle. Areas that may be considered for monitoring are the
containment deviceFor a complete
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diagonally opposite corner, and the center of the containment
device. If filters are used in the containment device, a fourth probe shall be placed on the inner side of the filter. For
thermal sterilization methods, calibrated temperature sensors shall be used to map the temperature profiles. For
sterilization processes that do not have specific mechanical probes, BIs that have been determined to be highly
resistant to the process and chemical indicators that have been designed specifically for the process shall be used to
map the sterilant penetration inside the containment device. The CIs shall meet the requirements of ANSI/AAMI/ISO
11140-1.
For containment devices that require a filter, testing shall be performed with commercially available filter material that
is compatible with the sterilization method and recommended by the containment device manufacturer. Compatible
filter material/commercial grades shall be clearly indicated in the product labeling.
For containment devices that require sterilization wrap, testing shall be performed with commercially available
sterilization wrap (e.g., high-basis-weight polyolefin). The type of sterilization wrap used shall be identified in the
sterility maintenance documentation (4.4.4.2).
For containment devices with valves or filters, the ability of the valve or filter to allow adequate penetration of the
-6
sterilant throughout its useful life shall be determined by demonstrating a 12-log reduction and an SAL of 10 .

5.7 Drying (if applicable)
Compliance with the requirements of 4.4.2 can be verified by visually inspecting the containment device following the
drying phase of the recommended sterilization cycle and a cool down time determined, if required. The test
methodology shall be documented as required in 4.4.2.2. There shall be no visible condensation or pooling on the
external surface of the containment device, and the contents of the containment device shall be free of visible
condensation. If wicking material is needed to facilitate drying of containment device contents, the manufacturer shall
provide appropriate directions in the IFU. For containment devices that require sterilization wrap, testing shall be
performed with commercially available sterilization wrap (e.g., high-basis-weight polyolefin). The type of sterilization
wrap used shall be identified in the sterility maintenance documentation (4.4.4.2).
NOTE 1—If condensation is observed within the containment device, gradually increase the drying time in increments until the
contents are dry; i.e., no condensation is observed. If it is determined that extended drying time is needed in the sterilization cycle,
this information should be included in the written IFU (see 4.5.2).
NOTE 2—Because immediate-use steam sterilization (formerly known as flash sterilization) cycles do not include drying time, some
degree of condensation may be present in containment devices FDA-cleared for immediate-use steam sterilization. A validation for
maintenance of the sterility of the contents from the sterilizer to the point of use should be performed, as well as any storage time.
5.8 Sterilant residual removal (if applicable)
Testing shall be performed in accordance with ANSI/AAMI/ISO 10993-7 for EO residuals.
The testing shall be performed using maximum load configurations in both the containment device and the sterilizer.
The recommended sterile barrier system shall be applied to the containment device prior to exposure to the sterilant.
To determine if there is any cumulative effect, the testing shall be conducted after each of 3 sterilization cycles and
aeration cycles under the conditions recommended by the manufacturer of the containment device. If a cumulative
effect that exceeds the allowable maximums established by ANSI/AAMI/ISO 10993-7 is observed, then changes to
the materials or changes to the aeration cycle shall be made and the testing shall be repeated.
5.9 Sterility
5.9.1 Sterility maintenance
5.9.1.1 General
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Compliance with the requirements of 4.4.4 can be verified by performing the sterilization testing of 5.6, exposing the
sterile barrier system to the expected stresses of storage, transport, and handling conditions, and then performing
either a whole-package microbial challenge test (5.9.1.2) or physical integrity tests (5.9.1.3).
Examples of intended to allow
expected stresses potential
that would purchasers
be encountered withintoa evaluate
health care the content
facility include movement of
containment devices into and out of the sterilizer and onto and off shelving or carts. Additional handling stresses and
of the
vehicle vibration should document
be considered before
if transport making
outside a care
the health purchasing decision.
facility is anticipated.

NOTE—Sterility maintenance testing of wrapped containment devices is intended to ensure that no punctures or tears occur during
sterilization and handling as a result of the device design. For containment devices that require wraps to maintain the sterile barrier,
the containment device manufacturer +1-877-249-8226 or visit
should test the containment device www.aami.org.
for sterility maintenance using wraps that have been FDA-
cleared as sterilization wraps.
5.9.1.2 Whole-package microbial challenge test
The containment device in its sterile barrier system shall be placed inside a chamber and then exposed to a defined
aerosol of microorganisms. Sterility testing of the contents of the containment device for the recovery of the challenge
organism shall be performed in accordance with USP.
5.9.1.3 Physical integrity tests
Physical integrity testing shall consist of the most appropriate test method for the intended sterile barrier system and
shall be scientifically sound.
Reusable rigid sterilization containers may be tested in accordance with EN 868-1, Annex G. Filters should be tested
separately for any degradation or damage by an appropriate microbial barrier test for porous materials, such as
ASTM 1608 or a bacterial filtration efficiency (BFE) test.
For wrapped containment devices, the sterilization wrap(s) shall be visually inspected for any holes or tears. If no
holes or tears can be identified, then physical testing of the worst-case areas, such as samples from the edges and
corners, shall be conducted. Hydrostatic pressure testing (e.g., AATCC 127) may be an appropriate method for this
evaluation.

Annex A
(Informative)
Medical device integration with rigid sterilization container systems
This Annex was developed for medical device manufacturers to respond to the increasing requests from users
to address the issues related to processing, handling, and validating sterilization for medical devices placed in
rigid sterilization containers. Medical device manufacturers need to ensure that their devices are compatible
with the recommended packaging methods and provide written instructions for reprocessing.
Questions arise when health care facilities wish to move equipment from a sterilization wrap process to a rigid
sterilization container or vice versa. Often manufacturers' written and validated instructions for use (IFU) only detail a
singular packaging method, and manufacturers do not know the extent of testing needed to establish validation in a
different packaging system. It is often assumed, correctly or not, that all wrapping materials are the same. This is
understood to not apply to rigid sterilization containers because they vary in sizes and methodologies for establishing
sterilization. Rigid sterilization containers are often produced for specific sterilization modalities. Alternately, rigid
sterilization containers may cover a wide variety of sterilization modalities. Rigid sterilization container systems vary
in their use. For example, some are for immediate-use steam sterilization (formerly known as flash sterilization) and
others are for sterile storage; some have perforations in the lid only and others have perforations in the lid and base;
filters used may vary in material type and use, etc. Information in this Annex refers to reusable rigid sterilization
containers.
A.1 Introduction
This Annex describes the critical path required to determine if a medical device(s) can be safely integrated into a rigid
sterilization container packaging system as an alternative packaging method over previously qualified, medical grade
sterilization wrap and processed in various sterilization modalities.
This information has been developed to help qualify the desired medical device(s) for appropriate integration within a
rigid sterilization container packaging system. Reviewing the indications for use section, the device manufacturer’s
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claims and labeling for each device should determine whether the new package combination, or device integration, is
within the indications for use of each device. These indications include but may not be limited to:
• This ismodality
Sterilization a preview
and cycle edition of an AAMI guidance document and is
parameters
• Total combined weight (devices, internal trays, and rigid sterilization container system)
• Lumen dimensions (i.e., internal diameter andpurchasers
intended to allow potential to evaluate
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• Complexityof the document
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• Material compatibility
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• Corrosion resistance to the specified sterilization method
• Verification of worst-case scenario for testing
A.2 Critical assessments
Rigid sterilization containers are intended to be used as the primary packaging material. Rigid sterilization container
packaging systems were first introduced to North America in the early 1980s. Since that time, new technologies have
entered the marketplace in the form of sterilization modalities and complexity of medical devices. Some of these
technological evolutions present lethality and sterility maintenance challenges that were not considered earlier.
Determining device, material, and modality compatibility has now become a necessary assessment. For these
reasons, caution is required when attempting to integrate new devices and materials within any particular rigid
sterilization container packaging system, considering these have their own unique device performance
characteristics. The rigid container manufacturer’s written IFU describes how the container can be used.
The following critical assessment tool was developed to assess whether the device intended or considered for
integration in a rigid sterilization container packaging system falls within the rigid sterilization container indications for
use and the requirements identified in this standard.

Table A.1 – Critical Assessment Comparison Tool
Medical Device(s) Rigid Container Packaging System
Material(s) of the device Material(s) of the container
Material compatibility
Lumens: Diameter, length, and Validation for lumens: Diameter,

material length, and material
Complexity of the device* Testing for complex devices and

multiple layers
Total weight Total weight including devices
Sterilization method(s) Sterilization method(s)
Cleaning guidelines Cleaning guidelines
Can device be disassembled Can container be disassembled
Corrosion resistance to avoid galvanic Corrosion resistance to avoid galvanic

reactions reactions
Passive layer Passive layer
Dimensional fit
Aseptic removal
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Stability of contents
Stacking
This is a preview edition of an AAMI guidance

Worst-case Volume document and is
to Vent (V-to-V)
ratio validated
*This must state the configuration of the device including the use of the exterior
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instrument copy
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and lid thisand
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in the
validation plan.
NOTE—The V-to-V ratio may be one of the metrics used in defining a worst-case challenge
for a family of containment devices. This ratio is defined as the interior volume of the
sterilization container divided by the total cross-section area of the perforated vent holes. V-
to-V ratio influence to the container system is influenced by the sterilization methodology.
For example, a dynamic air removal system will have lesser V-to-V ratio concerns
compared to a gravity displacement system. When the V-to-V ratio is critical to the
container system under consideration, a higher V-to-V ratio presents a more difficult
challenge to achieve the desired lethality performance and should be assessed.
For example, for a particular container volume, an increase in the cross-section area of the
perforations allows easier ingress and egress of the sterilant during the processing cycle.
Conversely, for a given perforation ratio—as interior volume is increased, it is more difficult
to fill and empty this volume through the same vent area. The worst-case V-to-V ratio does
not necessarily coincide with the largest container by volume or footprint. A full-size
container with two arrays of perforations may have a lower V-to-V ratio (i.e., easier to
empty and fill the internal volume) than a mid- or three-quarter size container with only one
array of perforated holes. Similarly, a full-size container with a solid bottom will have a
higher V-to-V ratio than the same full-size container with a perforated bottom, resulting in a
more difficult challenge to achieve the desired lethality performance.

Examples of groups for critical assessments:
Surface sterilization only:
• Stainless steel instruments

• Mixed loads
Sterilization of lumened devices:
• Rigid
• Flexible
• Lumen claims
Sterilization of power equipment
Sterilization of devices in trays:
• One layer
• Multiple layers
Material types:
• Aluminum
• Stainless steel
• Titanium
• Polymeric
• Hybrid (metal and plastic)
• Other
A.3 Validation plan
When initiating a validation for integrating medical devices into an existing rigid sterilization container packaging
system, conditions of the critical assessment are used to determine a test plan. The test plan should incorporate the
worst-case conditions of the devices planned for integration using the critical assessment criteria. Appropriate
• Medical devices used

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biological organism challenge is used in the defined plan worst-case location(s). The plan should include:
• Thisorganism
Biological is a preview
challengeedition
used of an AAMI guidance document and is
• intended
Location and type oftotheallow potential
biological challenge purchasers to spore
(liquid suspension, evaluate the content
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• Monitoring BI and CI used
A.4 FDA clearance considerations
It is the responsibility of the medical device manufacturer to provide validation for the sterilization of their devices. If a
rigid sterilization container system is used for the validation, it should fall within the cleared indications for the specific
manufacturer's rigid sterilization container.
Any parameter that extends beyond the acceptable criteria for sterilization, such as extended reprocessing time or a
new medical device not previously cleared, should be identified and may require additional 510(k) submissions. If a
formal validation project is required (e.g., when the device and package modality—in this instance rigid sterilization
container—do not fall within the rigid sterilization container indications for use), the medical device manufacturer
should conduct the appropriate validation testing.
NOTE—Validation testing should be done in accordance with applicable standards (i.e., AAMI, AORN, ASTM, etc.).
If the medical device, insert tray, and rigid sterilization container meet the labeling and current claims, a verification of
the device utilizing BIs may be conducted at health care facilities per the current standard.

A.5 Change control
Manufacturers' device master records are required to maintain integrity of the device throughout the life of that
device, and are used to record any changes to the device that are significant enough in nature to affect the cleared
indications for use.
Examples of significant device design changes might include, but are not limited to:
• Additional devices to the original validated integrated set contents

• Increased complexity of a device that has not been tested in the original validated integrated set contents
• Devices with lumens that have a smaller inner diameter or are longer than the cleared lumen dimensions
• Increase in weight from the original validated integrated set
• Inclusion of new materials
• Addition of new intended modality that has not previously been validated
• Design changes to the device(s)
• Changes in the V-to-V
• Changes in the validated filter media
• Number and dimensions/material of lumens
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Bibliography
American Association of Textile Chemists and Colorists. Water resistance: Hydrostatic pressure test. AATCC
Test Method 127-2008. Research Triangle Park (NC): AATCC, 2008.
th
Association for the Advancement of Medical Instrumentation. Hospital steam sterilizers. 5 ed. ANSI/AAMI ST8:2008.
Arlington (VA): AAMI, 2008. American National Standard.
Association for the Advancement of Medical Instrumentation. Automatic, general-purpose ethylene oxide sterilizers
nd
and ethylene oxide sterilant sources intended for use in health care facilities. 2 ed. ANSI/AAMI ST24:1999/(R)2009.
Association for the Advancement of Medical Instrumentation. Guidelines for the selection and use of reusable rigid
nd
sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities. 2 ed.
ANSI/AAMI ST33:1996. Arlington (VA): AAMI, 1996. American National Standard. (Withdrawn)
Association for the Advancement of Medical Instrumentation. Table-top dry heat (heated air) sterilization and sterility
nd
assurance in dental and medical facilities. 2 ed. ANSI/AAMI ST40:2004/(R)2010. Arlington (VA): AAMI, 2005.
Association for the Advancement of Medical Instrumentation. Ethylene oxide sterilization in health care facilities:
th
Safety and effectiveness. 4 ed. ANSI/AAMI ST41:2008/(R)2012. Arlington (VA): AAMI, 2008. American National
Standard.
nd
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ST55:2010. Arlington (VA): AAMI, 2010. American National Standard.
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This is a preview of "ANSI/AAMI ST77:2013 ...". Click here to purchase the full version from the ANSI store.

Advancing Safety in Health Technology

Objectives and uses of AAMI standards and

American National Standard ANSI/AAMI ST77:2013/(R)2018

Containment devices for

Approved 1 February 2013 and reaffirmed 6 September 2018 by

Keywords: containment devices, reusable rigid sterilization containers, instrument organizers.

© 2013 by the Association for the Advancement of Medical Instrumentation

All Rights Reserved

Printed in the United States of America

Glossary of equivalent standards .................................................................................................................................. iv

2 Normative references .............................................................................................................................................. 3

A Medical Device Integration With Rigid Sterilization Container Systems ................................................................ 19

Glossary of equivalent standards

iv © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

Association for the Advancement of Medical Instrumentation

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 v

Gordon M. Ely, WuXi AppTec Inc.

AAMI Sterilization Standards Committee

vi © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

Reynaldo Lopez, Cardinal Health (MP&S)

American National Standard ANSI/AAMI ST77:2013/(R)2018

Containment devices for reusable medical device

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 1

2 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 3

3 Definitions and abbreviations

For the purpose of this standard, the following definitions apply.

3.6 This isPeriod

+1-877-249-8226 or visit www.aami.org.

4 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

3.23 For aorganizer:

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 5

3.39 PREVIEW COPY

3.40 user This is a preview

3.41 validation:of the document

6 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

4.2 Materials of construction

4.2.2 Compatibility with the sterilization process

4.2.3 Corrosion resistance

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 7

4.3.4.1 Internal stacking

Internal stacking refers to two or more layers within a containment device.

e) a dry outcome (see 4.4.2.1);

4.3.4.2 External stacking

8 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

4.3.5 Maximum weight

4.3.6 Additional requirements for reusable rigid sterilization containers

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 9

4.3.6.3 Valves (if applicable)

4.3.6.5 Lid-base compatibility

4.3.6.7 Tamper-evident system

If a chemical indicator (CI) is provided, it shall comply with ANSI/AAMI/ISO 11140-1.

10 © 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013

4.4.1.1 General Requirements

© 2013 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST77:2013 11

i) if applicable, the results of chemical monitoring;

j) the sterilizer load configuration;

b) the minimum time for the drying phase;