Medical Device Sheet

I STERANIOS 2% ECS

I
TOXICOLOGICAL DATA

I Hazardous constituents: Pentanedial 1,5 or

Glutaraldehyde CAS no 111-30-8

I - lrritating product for eyes and respiratory system.

May cause sensitization by skin contact.

I :
- Exposure Limit Value to glutaraldehyde vapour : ELV 0,2 ppm or 0.8 mg/m3
This limit has been determined by the French Ministery of Employment in 1998

I -+ lf STERANIOS 2 o/o is used in places equiped with meehanical ventilation, the

vapours are under the official limit.

I
ENVIRONMENT
I - Do not throw in natural environment (rivers, soils and vegetation, ...).

I
INSTRUCTION FOR USE
I - For external use only. Do not swallow.
- Avoid contact with skin and eyes.

I - Do not inhale vapours.

- Ready to use product. Do not dilute.
- Do not mix with other products.
t - Check the expiry date,
- Close carefully after use.
- Clean and rinse carefully the instrumentation before soaking it in STERANIOS 2%.
I - Avoid transfering rinsing water (from the second bath) to the disinfection bath.
- Totally immerse the instruments in the disinfection bath.
- Disinfect the high risk parts, such as hollow or tubular instruments by injecting at least
t 100 ml of disinfectant.
- Do respect the contact time indicated on the Technical Sheet (No more than i hour).
- Check regularly the concentration of glutaraldehyde in the soaking bath carrying out a
I titrimetric analysls (the analysis method enclosed in the scientific file, is available on
request).
- Cover the soaking bath.

I
t FDM 710 A - STERANIOS 2o/o ECS - Page 1/3
 '!

-Change gloves befor the last rinsing (4th container).

- After the disinfection, rinse carrefully the instruments with sterile water (at least 300 ml)
- Renew rinsing baths after each use.
- After rinsing the instruments, display them on a sterile linen and dry with a sterile towel.
Carefully dry the hollow parts.
- Store instruments in cleaned and disinfected box.
- Clean, disinfect, dry the soaking containers and remove fur if necessary.
- Shelf life of the soaking bath : 30 days.

MEANS OF PROTECTION

- Wear suitable gloves and an eye and face protection.

- Provide an occular shower on the work room.
- Mind the rooms are well-ventilated.
- lnform all users about the risks and means of protection joined to STERANIOS 2% use.

FIRST-AID MEASURES

- In case of contact with eyes, rinse immediately with plenty of water, even under eyelids,
during '15 minutes at least. Seek medical advice.
- ln case of contact with skin, take off all contaminated clothing, wash yourself with water
and soap. ln case of irritation or allergy reaction, seek medical advice.
- lf swallowed : do not provoke vomiting. Use a gastric demulcent and seek medical advice
immediately, show him the label where possible.
- ln case of inhalation of product vapours, take the person outside and make him deeply
breath..
- Emergency telephone number : Centre Anti Poison Paris : +33.1 .40.37.04.04

SPILLAGE

- Wear suitable protection equipment.

- Small spillages can be rinsed with plenty of water.
- Big spillages must be picked up and thrown out. The spilled product can also be
neutralized by applying carefully a diluted solution of Sodium Bisulfite. Them rinse
thoroughly

FDM 710 A - STERANTOS 2o/o ECS - Page 2/3

 F

STOCKING

- store in cool, dry and weil-ventilated

areas (from + 5"c and + 35.c).
- Do not exceed the expiry date mentioned
on the raber.
- Keep the product in its original packaging.

FIRE PROCEDURES

- Non flammable aqueus solution.

extinction means in case of promixity fire, any fire fighting
l:tilltnded equipment can
- specific intervention methods : standard
methods for chemicar origin fire.
- special protection equipments in
case of fire : wear suiiante r."rpiri'torf.equipment
complete protection suit. and

INFORMATION

when necessary Laboratoires ANlos. are your disposal to answer all your questions
.at.
(Physicochemical, toxicorogicar, microbiorogicar,'re;lr;i;;...,informations...)

LABORATOIRES ANIOS
Telephone number : 33 3-20-67_67_67
Fax number : 33 3-20-67-G7-68

- A complete scientific file is available on request.

This sheet is based on our current knowledge.

user's attention is drawn besides on the
risks incured when using a product for a purpose
different from which it was conceived.

FDM 710 A - STERANTOS 2o/o ECS - page

3/3
2<y
 =-Fl

SAFETY DATA SHEET

LABORATOIRES ANIOS ln Compliance with Directive elllsslEEc

Laboratoires Pharmaceutiques No. F 9218

Pave du Moulin
F-59260 LILLE.H ELLEMMES
FRANCE
.57
Tel : +33.3.2 0.67 .67 Emergency Telephone Number.
Fax : +33.3.20.67.67.68 oRFILA: +331 45.42.59.59

1 - loeutlncltror.r

1.1 Product (Trade) Name: STERANIOS 2%ECS

1.2 Supp[er: Laboratoires ANIOS Tel : +33.3.20.67 .67 .67

Pavd du Moulin Fax : +33.3.2O.67 .67 .58
F.59260 LILLE-HELLEMMES

2 - CoMPosrfloN

2.1 General Chemical Description 2o/o glutaraldehyde solution (expressed in 'l0O% active ingredient,
USP XXI quality, buffered to pH 6 in a surface effect catalyst).

Pentanedial-1.5 (glutaraldehyde) CAS No. 1 11-30-08

2.2 Possible hazardous ingredients

3- IDEMTIFICATIoN oF HAZARDS

3. 1 Specific risks Xi: IRRITATING

R 36137:. lrritating for eyes and respiratory system

R 43: May cause sensitization by skin contact.

4 - FtRsr AID - lf
sprayed in eyes, wash immediately with plenty of water, even i

under eyelids, for at least 15 minutes. Seek medical advice. i

- lf spilled on skin, remove soiled clothing and wash with water and
soap. lf irritation or allergic reaction occr]r, seek medical advice.

- lf swallowed, do not provoke vomiting. Use a gastric demulcent

and seek immediately medical device. Show him the label where
possible.

- lf irritation is caused due to inhalation of product vapours, take the

person outside and make him breathe deeply.

SDS n"71 0 - 97 /A9/22 - paqe 1/4 +

5 - SprCnI FIRE FICHTING PROCEDURES
5. 1 Extinguishing Media
- Recommended The product itself does not burn. Any type of eKinguishing method
may be used if there is a fire close by.

Special fire-fighting methods Standard procedure for fires caused by chemicals.

Special equipment for fire-fighters Wear a self<ontained breathing apparatus and a complete
protective suit when fire-fighting.

6. SpII-I. OR LEAK PROCEDURES

6.1 Personal protection Wear suitable gloves.

6.2 Precautions to take to protect the Do not disperse in the natural environment (streams, ground and
environment forests, etc.).
Wear appropriate protective equipment.
6.3 Cleaning methods Small spills may be washed away with abundant quantities of water.
Larger volumei of spilled products should be collected before being
thrown away. The product may also be neutralised by carefully
pouring a diluted solution of sodium bisulfite on it. Then wash with
abundant quantities of water.

7 - Hruroulrc AND SToRAGE

7.1 Handling Product for external use onlY.

Do not inhale vapours.
Avoid spilling the product on skin or splashing in eyes'
Securely close after using.

7.2 Storage Store the product in its original packaging.

Store away from heat, in areas efficiently ventilated, at a

temperature between +5"C and +35"C.

Do not exceed the shelfJife date marked on the packaging.

8 - ExposuRr CoNrRot/ lNDlvlDUAt PRoTEcrloN Protection of hands : Suitable gloves.

Other protective steps : Provide an eye bath on work premises.
Make sure that the general ventilation of rooms is good.
lnform users about potential risks and means of protection
associated with the use of STERANIOS 2"/"ECS'

General protection and hygiene steps: Observe standard practices

and care applicable during the use of a chemical product'

9 . PHYSICJL ANO CHEMICAT DATA

9.1 Appearance +20"C

Physical state at ..: liquid, clear
Colour......... ...................:9reen
Odour ........: slight, tYPical
OlnLl
J.L Vt t Pure product .................':6.0 t 0.1 at +20'C

9.3 Specific GravttY 1.007 t O.OO2 g/cc at +20"C

9.4 Flash point Not applicable
9.5 Flammability Non-flammable
9.6 Others Dipping bath service life: 30 daYs

SDS n"710 - 97 /09122 - Page 2/4

10 - Srlsn-rry AND REAcnv[y DArA Chemically stable under conditions of use and storage.

,l0.1
Stability Do not mix with other products.

.10.2
Conditions to avoid Powerful inorganic and organic oxidising compounds, acids and
alkalis.
10.3 Materials to avoid
ln case of fire, the breakdown reaction causes emanation of carbon
monoxide and carbon dioxide.
10.4 Dangerous breakdown reaction Carbon monoxide is highly noxious when inhaled.
Carbon dioxide may become an asphyxiating gas in a sufficient
concentration.

11 - ToxcotocrcAl INFoRMATIoN

1 1.1 Skin irritation Assessment of skin tolerance in rabbits.

, Skin primary irritation index.
IPC = 0.37 - Nonirritating for skin.
May cause sensitisation in certain groups of sensitive people,
characterised by an allergic type skin disorder.

11 .2 Eye irritation Assessment o{ eye tolerance in rabbits.

1 r.3 roxicity by inhatation ilir:':i!:3j .1iXi.,,"n ror eyes.

12-EcoLoGtcALlNFoRMAroN No dangerous effect {or the environment is to be expected on the

basis of current knowledge.
Preparation biodegrades easily. No significant risk for aquatic flora
and fauna.
Weak concentrations do not affect the biological cycle of activated
sludqe and may be degraded in a waste water treatmeint system.'

13 - OBsERvAnoNs oN DtsposAL ln compliance with current regulations, contaminated packaging

must be taken to an approved incineration centre for specific waste.

14 - TRANsn9RTATIoN INFoRMATIoN Not listed as a dangerous material with regard to transport

regulations.

15 - REGULAToRv lNtoRMAloN Label complying with EEC directives.

Danger symbol(s): Xi: IRRITATING.

Risk pl'r.lrase5

R 36/37: lrritating for eyes and respiratory system

R 43: May cause sensitization by skin contact

Safetf phlases:
S 2: Keep out of the reach of children.
S 24/25: Avoid contact with eyes and skin.
S 26: ln case of contact with eyes, rinse immediately with plenty oi
water and seek medical advice.
S 37: Wear suitable gloves.

a7
SDS n"710 - 91/09122 - page 3/4
 16 - OrHen INFoRMATIoN

Recommended use and restrictions o{ lndications: Disinfecting of surgical and medical equipment.
u5e: Oisinfecting of endoscopy equipment and heat-sensitive equipment.

lVlelhgd of use: STERANIOS 2% ECS is ready to use. Do not dilute.

I Dip previously cleaned instruments in it in function of the required
spectrum of efficiency.
Contact time: 10 minutes - Bactericide, fungicide, viricidb.
t hour - Sporicide.
I Very carefully rinse with sterile water.
Perfect tolerance of use is provided by rinsing of instruments.

i The attention of the user is drawn to the regulatory oblrgations to

which he is committed in accordance with the clauses below. The
user is also reminded of the risks linked to using a product for a
purpose other than that for which it is intended.
I 'This data sheet does not replace but completes the information
contained in our technical instructions, and is based on our current

i degree of knowledge of the product concerned at the time of its

drifting. fhe user ii in no case exempt from becoming aware of and
applying all regulatory texts specific to his sector of activity. He will

i be held fully responsible for taking all precautionary measures

reguired and specific to his use of the product."
NOTE: ',The sole aim of these specifrcations is to assist the recipient
in fulfilling his obligations. This list should not be considered as
I exhaustive".

I
i
:
I
I
I
I
I

SDS n"71 O -97/09/22'Page 4/4

I