WHO/EPI/LHIS/97.

10
Original: English
Distribution: General

Equipment
performance specifications
and test procedures

E7: Cold chain accessories

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GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION

EXPANDED PROGRAMME ON IMMUNIZATION

World Health Organization, Geneva, 1997

Date of last revision of this module: 1 January 1998

 E7: Cold chain accessories

This module is part of the following series:

E1: Equipment performance specifications for cold rooms and freezer

rooms
E2: Equipment performance specifications for motorcycles
E3: Equipment performance specifications for refrigerators and freezers
E4 & E11: Equipment performance specifications for insulated containers
E5: Equipment performance specifications for icepacks
E6: Equipment performance specifications for temperature monitoring
devices
E7: Equipment performance specifications for cold chain accessories
E8: Equipment performance specifications for injection devices
E9: Equipment performance specifications for steam sterilizers
E10: Equipment performance specifications for injection accessories
Annexes

ii Equipment performance specifications and test procedures

Equipment Performance Specifications

Contents

Equipment Performance Specifications

Equipment Specification Applies to Page

reference test procedure

Equipment descriptions 1

Voltage regulator for compression E7/VR.1 E7/PROC/1 2

refrigerators

Voltage regulator for absorption E7/VR.2 E7/PROC/2 4

refrigerators

Test Procedures

Equipment Procedure Applies to Page

reference specification

General test conditions for automatic 6

voltage regulators

Voltage regulators for compression E7/PROC/1 E7/VR.1 7

refrigerators

Voltage regulators for absorption E7/PROC/2 E7/VR.2 11

refrigerators

Standby generators for vaccine E7/PROC/4 [None set] 14

refrigerators, freezers and stores

This module contains references to the following annexes, printed separately in

WHO/EPI/LHIS/97.14:
Annex 1: Testing institutions
Annex 8: Test procedures drawn from IEC 335-1 (1991) and Amendment 1
(1994-11), 'Safety of household and similar electrical appliances'

WHO/EPI/LHIS/97.10 iii
Equipment Performance Specifications

E7:
Equipment performance
specifications for cold chain
accessories

Equipment descriptions

Voltage regulators:
E7/VR.1 Voltage regulator. To provide a controlled electricity supply for a
compression type refrigerator or freezer.
E7/VR.2 Voltage regulator. To provide a controlled electricity supply for an
absorption type refrigerator or freezer.

Alarm systems:
E7/AS.1 Alarm system. To provide an audible and visible warning when a
refrigerator or freezer containing vaccines exceeds the safe storage
temperature range.

WHO/EPI/LHIS/97.10 1
 E7: Cold chain accessories

VOLTAGE REGULATOR FOR COMPRESSION

REFRIGERATORS
Specification reference: E7/VR.1
Applies to procedures: E7/PROC/1
Date of last revision: 1 January 1998

Type:
For compression refrigerators and/or freezers

Voltage/frequency:
Nominal 220 V 50 Hz supplies.

Capacity rating:
Minimum 500 VA continuous running. Under full rated load conditions, 10
successful starts out of 10.

Operating voltage ranges:

Input: [140 to 145 V] to [275 to 280 V]
Output range: 220 V ±10%.

Protection voltage range:

Input: 0 to 450 V without damage.
Output: Shall switch to 0 V at the limits of the input operating
range.

Delay in restoring supply:

When under or over-voltage cut-out has occurred and the input voltage has
returned to the operating range, the delay in restoring output voltage shall be
between 6 to 12 minutes.

Electrical safety:
Passes specified clauses in IEC 335-1 (1991) and Amendment 1 (1994-11)
(as described under Standard Test Procedure E7/PROC/1).

Endurance:
Shall continue to operate satisfactorily under full load conditions during 96
hours at +43°C and 95% relative humidity when the input voltage is varied
between the limits of the operating input voltage range at a frequency of 10
cycles per minute (electricity supply is 50 Hz).

Quality assurance:
Each instrument to be supplied with a record of the internal quality assurance
tests performed by the supplier.

Robustness:
Shall resist without mechanical damage vibration and mechanical shock test IEC
68-2-6 Part FC (as described in WHO Standard Test Procedure E7/PROC/1).

2 Equipment performance specifications and test procedures

Equipment Performance Specifications

Visual warnings:
Warnings are required in a visible position to indicate changes in voltage
output/output:
• an orange LED when the output voltage is greater than zero
• a green LED when the input voltage is greater than zero

Construction:
All components of the voltage regulator to be assembled and securely locked on
an epoxy laminated or galvanized metal chassis with protective casing. The
printed circuit board (PCB) shall be strong enough to withstand extremely rough
handling conditions and shall be marked with the name of the manufacturer,
trademark, type and month/year of manufacture.

Essential features:
Input lead 2 metres long, 3 core PVC insulated electrical cable with plug which is
standard in the country of manufacture and, if appropriate, has an earth
connection.
Earthed output socket shall have a plug fitted.
Input circuit breaker.

Packing:
Each instrument shall be protected with adequate buffer padding material
(minimum 100 mm on all sides) and over-packed in a strong waterproof triple-
wall cardboard carton (1000 pound test carton) or a strong wooden box.
The packing shall be adequate to withstand extremely rough handling
conditions during transit from factory to final destination by sea, air or rail, as
well as various forms of inland transportation.

Manuals:
Each voltage regulator to be accompanied by a detailed instruction manual in
the appropriate language.

WHO/EPI/LHIS/97.10 3
 E7: Cold chain accessories

VOLTAGE REGULATOR FOR ABSORPTION

REFRIGERATORS
Specification reference: E7/VR.2
Applies to procedures: E7/PROC/2
Date of last revision: 1 January 1998

Type:
For absorption refrigerators and/or freezers

Voltage/frequency:
Nominal 220 V 50 Hz supplies.

Capacity rating:
Minimum 0.5 KVA.

Operating voltage ranges:

Input: [140 to 145 V] to [275 to 280 V]
Output: 220 V ± 5%.

Protection voltage range:

Input: 0 to 450 V without damage.
Output: Shall switch to 0 V at the limits of the input operating range.

Delay in restoring supply:

When under or over-voltage has occurred and the input voltage has returned to
the operating range, the delay in restoring output voltage shall not be less than 2
minutes.

Electrical safety:
Passes specified clauses in IEC 335-1 (1991) and Amendment 1 (1994-11)
(as described under Standard Test Procedure E7/PROC/2).

Endurance:
Shall continue to operate satisfactorily under full load conditions during 96
hours at +43°C and 95% relative humidity when the input voltage is varied
between the limits of the input operating range at a frequency of 10 cycles per
minute (electricity supply is 50 Hz).

Quality assurance:
Each instrument to be supplied with a record of the internal quality assurance
tests performed by the supplier.

Robustness:
Shall resist without mechanical damage vibration and mechanical shock test IEC
68-2-6 Part FC (as described in WHO Standard Test Procedure E7/PROC/2).

4 Equipment performance specifications and test procedures

Equipment Performance Specifications

Visual warnings:
Warnings are required in a visible position to indicate changes in voltage
output/input:
• an orange LED when the output voltage is greater than zero
• a green LED when the input voltage is greater than zero

Construction:
All components of the voltage regulator to be assembled and securely locked on
an epoxy laminated or galvanized metal chassis with protective casing. The
printed circuit board (PCB) shall be strong enough to withstand extremely rough
handling conditions and shall be marked with the name of the manufacturer,
trademark, type and month/year of manufacture.

Essential features:
Input lead 2 metres long, 3 core PVC insulated electrical cable with plug which is
standard in the country of manufacture and has an earth connection.
Earthed output socket shall have a plug fitted.
Input circuit breaker.

Packing:
Each instrument should be protected with adequate buffer padding material
(minimum 100 mm on all sides) and over-packed in a strong waterproof triple-
wall cardboard carton (1000 pound test carton) or a strong wooden box.
The packing shall be adequate to withstand extremely rough handling
conditions during transit from factory to final destination by sea, air or rail, as
well as various forms of inland transportation.

Manuals:
Each voltage regulator to be accompanied by a detailed instruction manual in
the appropriate language.

WHO/EPI/LHIS/97.10 5
 E7: Cold chain accessories

Standard test procedures

General test conditions for automatic voltage

regulators

1. Introduction
The purpose of this test schedule is to check the suitability of the units for their
effectiveness in controlling the supply voltage to a refrigerator when the mains
input voltage is varying. Such a situation is typical of that existing in many
developing countries.

2. Inspection
All samples should be examined on receipt. Details of any defects or damage
should be recorded. All markings on the equipment, or on any component that
is readily accessible should be recorded. Installation of the equipment should
follow closely the manufacturer's instructions.
Describe briefly how each control unit operates. Record:
• Major dimensions (±2 mm).
• Check that essential features, as described in paragraph 7, are provided.
• Check that fixing of components, printed circuits and chassis conform with
specifications.
• Check that packing conforms with specifications.
• Check for the presence or absence of a record of quality assurance tests.

Details of all external controls, fuses, indicator lights, manual switches etc.
• Type and length of any cable/flex.
• Type of output (3 pin plug/socket hardwired, etc).
A three quarter view photograph should be taken of the sample.
The manufacturer should state the rating of the electrical insulation used in
transformer windings.

3. Reporting
The report should describe the results of each test, including instrument
readings and plotted data where relevant.
A summary should be provided at the beginning to indicate if all the required
specifications are met.
Reasons for not meeting any of the required specifications should be discussed
in the report.

6 Equipment performance specifications and test procedures

Test Procedurs

VOLTAGE REGULATORS FOR COMPRESSION

REFRIGERATORS
Procedure reference: E7/PROC/1
Applies to specification E7/VR1
Date of last revision: 1 January 1998

1. Voltage regulation range

Test condition:
Room ambient temperature and humidity.

Procedure:
Connect a 220 V, single phase, capacitor start induction motor, nearest
equivalent to rated capacity of voltage regulator to the output of the voltage
control unit. Connect output from the motor to a dynamometer so that calibrated
loads of 1/2 and 1/1 capacity can be obtained. The input to the control unit
should be variable from 0 to 450 volts AC.

Test Variable Constants Measurements

required
1 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - none
2 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - 1/5 of
rated KVA
3 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - 1/2 of
rated KVA
4 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - 1/1 of
rated KVA.

Results should be given in graphical form where appropriate and compared

with the stalling characteristics of the test motor.

Test criteria for qualification:

Operating voltage range:
• Input range [140V - 145V] to [275V - 280V]
• Output range 220V ± 10%.

WHO/EPI/LHIS/97.10 7
 E7: Cold chain accessories

2. High load starting

Test condition:
Room ambient temperature and humidity.

Procedure:
Set the input voltage under full load condition to the minimum in the operating
range (see procedure 1) plus 5 volts and cold start a single phase; capacitor start
induction motor of rated capacity ten times.

Test criteria for qualification:

Ten successful starts out of ten.

3. Endurance test

Test condition:
+43°C ±1°C @ RH 95%.

Procedure:
Connect each unit to the inductive load of full rated KVA and vary the input
voltage between the minimum in the operating range (see procedure 1) plus 10
V, and the maximum (see procedure 1) minus 10 V, at a frequency of l0
cycles/minute. The mains input frequency should be 50 Hz. The test should be
continued for at least 96 hours. Report any breakdowns.
Continue the above test for a period of twelve hours holding the supply voltage
constant at the lower end of the operating voltage range (on tap-change
regulators, immediately below the first tap change). Continue test for further 12
hours with the input voltage held at 275 V.

Test criteria for qualification:

The load shall continue to operate continuously and satisfactorily during the test
period.

4. High/low voltage cut-off test

Test condition:
Room ambient temperature.

Procedure:
The input voltage should be varied in 2 V intervals from 220 V to 0 V and from
220 V to 300 V in order to establish the voltage at which low and high cut-out
occur when connected to the standard inductive load of full rated KVA. The
voltage at which the cut-out operates should be maintained for a period of 1
minute followed by a recorded period at 220 V until output voltage is restored.
A check should be made that 450 V during 30 seconds can be applied to the
input with the same load causing the cut-out and auto-reset to operate normally
without damage to the regulator components.

8 Equipment performance specifications and test procedures

Test Procedurs

Test criteria for qualification:

The over/under-voltage protection cut-out shall operate in the range 275-280 V
and 140-145 respectively, cutting the output voltage to zero, and then
automatically restore output after a delay of six to twelve minutes, when the
input voltage is restored to the range 140 - 280 V. The overvoltage cut-out shall
operate normally at an input voltage of 450 V without damage to the regulator
components.

5. Vibration

Test condition:
Room ambient temperature.

Procedure:
Sample in packaging, firmly strapped to vibrating table. Conduct vibration tests
following IEC 68-2-6 part FC as follows:
• frequency: 10-150-10 Hz,
• amplitude: (mean to peak) 0.35 mm,
• rate of change: approx 1 octave per minute
• acceleration: limited to 2 g (cross over at 37 Hz),
• direction: vertical,
• endurance: 20 sweep cycles.
The regulator(s) should then be unpacked and inspected for damage. Any
damage to the package or the inside or the outside of the regulator should be
reported and, if necessary, photographed to give a clear explanation of the
damage.

Test criteria for qualification:

There should be no damage to circuit boards or their mountings and the unit
should function normally. Circuit boards, their mountings and the unit should
function normally. Light damage to crating is acceptable but collapse of the crate
enabling the regulator to fall out is not acceptable.

6. Electrical safety testing

Procedure:
Test procedures are drawn from IEC 335-1 (1991) and Amendment 1 (1994-11),
'Safety of household and similar electrical appliances', following the clauses
listed in Annex 8.

Test criteria for qualification:

Pass on listed clauses of IEC 335-1.

7. Essential features
The presence of the following features should be noted in the report, together
with comments on their adequacy:

WHO/EPI/LHIS/97.10 9
 E7: Cold chain accessories

• output indicator light (orange LED) in clearly visible position,

• minimum two metre long, earthed supply cable,
• fuse for supply side with spare fuses, residual current circuit breaker for the
input side accessible from outside the unit, output socket with mating plug,
• input plug standard in country of manufacture,
• input voltage indicator (green LED).
Examine the regulator(s) and comment on the design in the light of the test
results, the range of application, and general quality of construction. Indicate
any simple improvements which could be carried out to enhance the
performance or likely durability.

8. Manuals
All voltage regulators must be accompanied by detailed instruction booklets in
the appropriate language.

10 Equipment performance specifications and test procedures

Test Procedurs

VOLTAGE REGULATORS FOR ABSORPTION

REFRIGERATORS
Procedure reference: E7/PROC/2
Applies to specification E7/VR2
Date of last revision: 1 January 1998

1. Voltage regulation range

Test condition:
Room ambient temperature and humidity.

Procedure:
Connect a 220 V, resistive load equal to the rated capacity of the voltage control
unit. The input to the control unit should be variable from 0 to 450 V AC.

Test Variable Constants Measurements

required

1 Voltage Frequency - 50 Hz Voltage output

0-300 V AC Load - none
2 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - 1/5 of
rated capacity
3 Voltage Frequency - 50 Hz Voltage output
0-300 V AC Load - full
rated capacity.
Results should be given in graphical form where appropriate and compared
with the stalling characteristics of the test motor.

Test criteria for qualification:

Operating voltage range:
Input range (140-145) to (275-280) V.
Output range 220 ±5%.

2. Electrical safety

Procedure:
Test procedures are drawn from IEC 335-1 (1991) and Amendment 1 (1994-11),
'Safety of household and similar electrical appliances', following the clauses
listed in Annex 8.

Test criteria for qualification:

Pass on listed clauses of IEC 335-1.

WHO/EPI/LHIS/97.10 11
 E7: Cold chain accessories

3. Endurance test

Test condition:
+43°C ±1°C @ RH 95%.

Procedure:
Connect each unit to the resistive load of full rated capacity and vary the input
voltage between the minimum in the operating range (see procedure 1) plus 5 V,
and the maximum (see procedure 1) minus 5 V, at a frequency of l0 cycles per
minute. The mains input frequency should be 50 Hz. The test should be
continued for at least 96 hours. Report any breakdowns.
Continue the above test for a period of twelve hours holding the supply voltage
constant at the lower end of the operating voltage range. (on tap-change
regulators, immediately below the 1st tap change). Continue the test for a further
12 hours with input voltage held at 275 V.

Test criteria for qualification:

The load shall continue to operate continuously and satisfactorily during the test
period.

4. High/low voltage cut-off test

Test condition:
Room ambient temperature.

Procedure:
The input voltage should be varied in 2 V intervals from 220 V to 0 V and from
220 V to 300 V in order to establish the voltage at which the high cut-off occurs
when connected to the standard resistive load of full rated capacity. The voltage
at which the cut-out operates should be maintained for a period of 1 minute
followed by a recorded period at 220 V until the output voltage is restored. A
check should be made that 450 V during 30 seconds can be applied to the input
with the same load causing the cut-out and auto-reset to operate normally
without damage to the regulator components.

Test criteria for qualification:

The overprotection cut-out shall operate in the range 275-280 V, 140-145 V
respectively cutting the output voltage to zero, and then automatically restore
output after a delay which shall not be less than two minutes.
The overvoltage cut-out shall operate normally at an input voltage of 450 V
without damage to the regulator components.

5. Vibration

Test condition:
Room ambient temperature.

12 Equipment performance specifications and test procedures

Test Procedurs

Procedure:
Sample in packaging, loosely strapped to vibrating table. Conduct vibration tests
following IEC 68-2-6 part FC as follows:
• frequency: 10-150-10 Hz;
• amplitude: (mean to peak) 0.35 mm;
• rate of change: approx 1 octave per minute;
• acceleration: limited to 2 g (cross over at 37 Hz);
• direction: vertical;
• endurance: 20 sweep cycles.
The regulator(s) should then be unpacked and inspected for damage. Any
damage to the package or the inside or the outside of the regulator should be
reported and, if necessary, photographed to give a clear explanation of the
damage.

Test criteria for qualification:

There should be no damage to circuit boards or their mountings and the unit
should function normally. Light damage to crating is acceptable but collapse of
the crate enabling the regulator to fall out is not acceptable.

6. Essential features
The presence of the following features should be noted in the report, together
with comments on their adequacy:
• output and output indicator light (orange LED) in clearly visible position,
• fuse for supply side with spare fuses,
• minimum two meter long, earthed cable,
• circuit breaker for the supply side accessible from outside the unit,
• output socket with mating plug.
• input plug standard in country of manufacture,
• input voltage indicator (green LED).
Examine the regulator(s) and comment on the design in the light of the test
results, the range of application, and general quality of construction. Indicate
any simple improvements which could be carried out to enhance the
performance or likely durability.

7. Manuals
All voltage regulators must be accompanied by detailed instruction booklets in
the appropriate language.

WHO/EPI/LHIS/97.10 13
 E7: Cold chain accessories

STANDBY GENERATORS FOR VACCINE

REFRIGERATORS, FREEZERS & STORES
Procedure reference: E7/PROC/4
Applies to: (No Standard Performance Specification)
Date of last revision: 1 January 1998

Performance test

Test conditions:
Ambient conditions, unless otherwise stated.

1. Voltage regulation

Procedure:
Note voltage under the following load tests:

1.1 No load
1.2 Electrolux TCW 1151 (ice lining refrigerator/freezer)
1.3 Electrolux TCW 1151 x 2
1.4 Electrolux TCW 1151 x 2 + Electrolux TFW 800 or TFW 791 (ice pack
freezer)
1.5 Electrolux TCW 1151 x 2 + Electrolux TFW 800 or TFW 791 + 400 W
(resistive load/unity power factory)

Test criteria for qualification:

No standard set

2. Speed of response to momentary overloading

Procedure:
Set the generator to produce 1000 VA output less than rating plate discontinuous
value. Switch a TCW 1151 into the generator load circuit. Measure the speed of
voltage recovery.

Test criteria for qualification:

No standard set

3. Maximum continuous output power

Procedure:
Measure the maximum continuous output power for a 30 minute period, using a
resistive/unity power factor load, the value of which is determined empirically
for each unit. During this period, assess provision for overload protection.

14 Equipment performance specifications and test procedures

Test Procedurs

Test criteria for qualification:

4. Peak load test

Procedure:
With the generator running under no load conditions, switch in simultaneously
2 x TCW 1151 + TFW 800 or TFW 791. Note effect.

Test criteria for qualification:

No standard set

5. Provision for overload protection

Procedure:
Following test 3 above, increase the load by 20% (minimum) and assess the
effect.

Test criteria for qualification:

6. Provision for short circuit and fault protection

Procedure:
Run with line and neutral shorted together and comment on effect. If necessary,
short line to earth and assess results.

Test criteria for qualification:

No standard set

7. Electrical safety

Procedure:
Inspect for access to live parts, wiring terminals and moving parts. Subject
samples to electric strength test before and after oblique rainfall test.

Test criteria for qualification:

No standard set

8. Noise
Measure noise levels in accordance with methods given in the EEC directive for
construction plant noise 84/536/EEC.

9. Endurance
Loads as load in paragraph 1.4 above. Compressors (in the TCW 1151 and
TFW 791) to cycle as normal. Running period: 10 x 12 hours on 12 hours off,
followed by 168 hours on for this test. A minimum of 1,000 hours running is
recommended.

WHO/EPI/LHIS/97.10 15
 E7: Cold chain accessories

10. Environment tolerance

10.1 On-slope operating stability (15° incline). Sample turned through 90°
every 30 minutes to assess any toppling or engine distress.
10.2 Effect of running out of fuel. Test carried out on flat ground.

11. Installation and maintenance

11.1 Assess ease of installation.
11.2 Detail manufacturer's recommended maintenance schedule:
• for engine,
• for alternator
11.3 Note where data supplied, i.e. fastened to motor, on separate leaflet, etc.
11.4 Assess ease of undertaking routine maintenance including ease of
changing starting mechanism. Note special tools required.
11.5 Assess quality of literature supplied.

12. Engineering assessment

Undertake an engineering assessment, paying particular attention to:
• quality of workmanship,
• finish,
• general assembly and marking corrosion protection,
• instrumentation,
• guarding,
• dust proofing.

13. Ergonomic assessment

Convenience of operation assessment to be undertaken. Note also vulnerability
of switches, dials, etc.

14. Recommended modifications

Laboratory staff to recommend product modifications which would benefit
manufacturer/WHO, for example, run clock, trip circuitry, etc.

16 Equipment performance specifications and test procedures