AS 3864-1997

1 - AS 3864-1997 MEDICAL REFRIGERATION EQUIPMENT-FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS
4 - PREFACE
5 - CONTENTS
7 - SECTION 1 SCOPE AND GENERAL
7 - 1.1 SCOPE
7 - 1.2 REFERENCED DOCUMENTS
8 - 1.3 DEFINITIONS
8 - 1.3.1 Blood pack
8 - 1.3.2 May
8 - 1.3.3 Plasma pack
8 - 1.3.4 Power consumption
8 - 1.3.5 Rated storage capacity
8 - 1.3.6 Service load capacity
8 - 1.3.7 Shall
8 - 1.3.8 Should
8 - 1.4 ELECTRICAL SAFETY
8 - 1.5 CARE AND MAINTENANCE
8 - 1.6 MARKING
8 - 1.6.1 Cabinet
8 - 1.6.2 Refrigerated room
9 - SECTION 2 SELF-CONTAINED REFRIGERATION EQUIPMENT FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS IN THE TEMPERATURE RANGE ....
9 - 2.1 SCOPE OF SECTION
9 - 2.2 CONSTRUCTION
9 - 2.2.1 External finish
9 - 2.2.2 Thermal insulation
9 - 2.2.3 Internal finish
9 - 2.2.4 Shelves and partitions
10 - 2.2.5 Doors
10 - 2.2.6 Access
10 - 2.2.7 Levelling screws/castors
10 - 2.3 LIGHTING
10 - 2.3.1 General
10 - 2.3.2 Lamps and lampholders
10 - 2.4 REFRIGERATION SYSTEM
10 - 2.4.1 General
10 - 2.4.2 Noise
10 - 2.4.3 Ice-free operation
10 - 2.4.4 Security of refrigeration control system
10 - 2.5 GENERAL CONDITIONS OF TESTING
10 - 2.6 PERFORMANCE REQUIREMENTS
10 - 2.6.1 External surface temperature
11 - 2.6.2 Operation
11 - 2.6.3 Service load capacity
11 - 2.6.4 Power consumption
11 - 2.6.5 Compressor operating time
11 - 2.6.6 Maximum cycling frequency
11 - 2.6.7 Heat insulating capacity
11 - 2.7 INSTRUMENTS AND TEMPERATURE MEASURING APPARATUS
11 - 2.7.1 Temperature recorder
12 - 2.7.2 Alarm systems
12 - 2.7.3 Independent operation of refrigeration control and alarm systems
12 - 2.7.4 Thermal lagging
12 - 2.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
14 - SECTION 3 SELF-CONTAINED REFRIGERATION EQUIPMENT FOR THE STORAGE OF BLOOD PLASMA AND PLASMA PRODUCTS AT OR BELOW -25 DEGREE
14 - 3.1 SCOPE OF SECTION
14 - 3.2 CONSTRUCTION
14 - 3.2.1 External finish
14 - 3.2.2 Thermal insulation
14 - 3.2.3 Internal finish
14 - 3.2.4 Shelves and partitions
14 - 3.2.5 Lids and doors
14 - 3.2.6 Access
15 - 3.2.7 Levelling screws/castors
15 - 3.2.8 Load limits
15 - 3.3 REFRIGERATION SYSTEM
15 - 3.3.1 General
15 - 3.3.2 Static system
15 - 3.3.3 Forced draught system
15 - 3.3.4 Noise
15 - 3.3.5 Refrigeration control device
15 - 3.4 GENERAL CONDITIONS OF TESTING
16 - 3.5 PERFORMANCE REQUIREMENTS
16 - 3.5.1 Product temperature
16 - 3.5.2 Power consumption
16 - 3.5.3 Operation
16 - 3.5.4 External surface temperature
16 - 3.5.5 Compressor operating time
16 - 3.5.6 Maximum cycling frequency
16 - 3.5.7 Heat insulating capacity
16 - 3.6 INSTRUMENTS AND TEMPERATURE CONTROL APPARATUS
16 - 3.6.1 Temperature recorder
17 - 3.6.2 Alarm systems
17 - 3.6.3 Independent operation of refrigeration control and alarm systems
17 - 3.6.4 Thermal lagging
17 - 3.7 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
18 - SECTION 4 WALK-IN TYPE COOLROOMS FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS IN THE TEMPERATURE RANGE ....
18 - 4.1 SCOPE OF SECTION
18 - 4.2 CONSTRUCTION
18 - 4.2.1 General
18 - 4.2.2 Crash barriers
18 - 4.2.3 Joints
18 - 4.2.4 External finish
18 - 4.2.5 Thermal insulation
18 - 4.2.6 Internal finish
19 - 4.2.7 Windows
19 - 4.2.8 Pressure relief devices
19 - 4.2.9 Shelves and partitions
19 - 4.2.10 Air distribution devices
19 - 4.2.11 Doors
20 - 4.2.12 Defrost and condensate drainpipes
20 - 4.3 LIGHTING
20 - 4.3.1 General
20 - 4.3.2 Lamps and lampholders
20 - 4.4 REFRIGERATION SYSTEM
20 - 4.4.1 General
20 - 4.4.2 Ice-free operation
20 - 4.4.3 Air circulation
20 - 4.5 GENERAL CONDITIONS OF TESTING
20 - 4.6 PERFORMANCE REQUIREMENTS
21 - 4.6.1 External surface temperature of coolroom
21 - 4.6.2 Blood pack temperature
21 - 4.6.3 Compressor operating time
21 - 4.6.4 Maximum cycling frequency
21 - 4.6.5 Heat insulating capacity
21 - 4.7 INSTRUMENTS AND TEMPERATURE MONITORING APPARATUS
21 - 4.7.1 Temperature recorder
22 - 4.7.2 Alarm systems
22 - 4.7.3 Independent operation of refrigeration control and alarm systems
22 - 4.7.4 Thermal lagging
22 - 4.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
24 - SECTION 5 WALK-IN TYPE FREEZER ROOMS FOR THE STORAGE OF BLOOD PLASMA AND PLASMA PRODUCTS AT OR BELOW -25 DEGREE
24 - 5.1 SCOPE OF SECTION
24 - 5.2 CONSTRUCTION
24 - 5.2.1 General
24 - 5.2.2 Crash barriers
24 - 5.2.3 Joints
24 - 5.2.4 External finish
24 - 5.2.5 Thermal insulation
24 - 5.2.6 Internal finish
25 - 5.2.7 Windows
25 - 5.2.8 Pressure relief device
25 - 5.2.9 Shelves and partitions
25 - 5.2.10 Air distribution devices
25 - 5.2.11 Doors
26 - 5.2.12 Defrost and condensate drainpipes
26 - 5.3 LIGHTING
26 - 5.3.1 General
26 - 5.3.2 Lamps and lampholders
26 - 5.4 REFRIGERATION SYSTEM
26 - 5.4.1 General
26 - 5.4.2 Ice-free operation
26 - 5.4.3 Air circulation
26 - 5.5 GENERAL CONDITIONS OF TESTING
26 - 5.6 PERFORMANCE REQUIREMENTS
27 - 5.6.1 External surface temperature of freezer room
27 - 5.6.2 Plasma pack temperature
27 - 5.6.3 Compressor operating time
27 - 5.6.4 Maximum cycling frequency
27 - 5.6.5 Heat insulating capacity
27 - 5.7 INSTRUMENTS AND TEMPERATURE MONITORING APPARATUS
27 - 5.7.1 Temperature recorder
28 - 5.7.2 Alarm systems
28 - 5.7.3 Independent operation of refrigeration control and alarm systems
28 - 5.7.4 Thermal lagging
28 - 5.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
30 - APPENDIX A - CARE AND MAINTENANCE OF REFRIGERATION EQUIPMENT
30 - A1 GENERAL
30 - A2 RECORDING THERMOGRAPH AND ALARMS
30 - A3 DOOR SEALS
30 - A4 CLEANING
31 - APPENIDX B - GENERAL TEST CONDITIONS
31 - B1 SCOPE
31 - B2 GENERAL
31 - B3 TEST ROOM
31 - B3.1 General
31 - B3.2 Measurement of ambient temperature
31 - B3.3 Temperature distribution
31 - B3.4 Temperature conditions
31 - B4 MEASURING INSTRUMENTS
31 - B4.1 Temperature-measuring instruments
32 - B4.2 Electrical instruments
32 - B5 PREPARATION FOR TESTING
32 - B6 OPERATING REQUIREMENTS FOR THE CABINET OR ROOM
32 - B7 ELECTRIC POWER SUPPLY
32 - B8 STABLE OPERATING CONDITIONS
33 - APPENDIX C - METHOD FOR DETERMINING EXTERNAL SURFACE TEMPERATURE OF A REFRIGERATION CABINET MAINTAINED IN THE TEMPERATURE ....
33 - C1 SCOPE
33 - C2 PRINCIPLE
33 - C3 APPARATUS
33 - C4 TEST CONDITION
33 - C5 PREPARATION OF THE CABINET
33 - C6 PROCEDURE
33 - C7 REPORT
34 - APPENDIX D - OPERATION TEST FOR A REFRIGERATION CABINET FOR THE STORAGE OF BLOOD AND BLOOD PRODUCTS IN THE TEMPERATURE RANGE ...
34 - D1 SCOPE
34 - D2 PRINCIPLE
34 - D3 APPARATUS AND MATERIALS
34 - D3.1 For minimum loading
34 - D3.2 For maximum loading
34 - D4 PROCEDURE
34 - D4.1 Minimum load
35 - D4.2 Maximum load
35 - D5 REPORT
37 - APPENDIX E - METHOD FOR DETERMINATION OF SERVICE LOAD CAPACITY OF A REFRIGERATION CABINET
37 - E1 SCOPE
37 - E2 PRINCIPLE
37 - E3 APPARATUS
37 - E4 PREPARATION OF THE CABINET
37 - E5 TEST PROCEDURE
38 - E6 CALCULATION
38 - E7 REPORT
41 - APPENDIX F - METHOD FOR DETERMINATION OF HEAT INSULATING CAPACITY OF A REFRIGERATION CABINET
41 - F1 SCOPE
41 - F2 PRINCIPLE
41 - F3 APPARATUS
41 - F4 PROCEDURE
41 - F5 REPORT
42 - APPENDIX G - METHOD FOR TESTING TEMPERATURE RECORDER AND ALARM SYSTEMS
42 - G1 SCOPE
42 - G2 PRINCIPLE
42 - G3 APPARATUS
42 - G4 PROCEDURE
42 - G4.1 For refrigeration cabinets and coolrooms maintained in the temperature range 2°C to 6°C
44 - G4.2 For deep freeze cabinets and freezer rooms maintained at -25 degree C or lower
45 - G5 REPORT
46 - APPENDIX H - OPERATION TEST FOR A DEEP FREEZE CABINET
46 - H1 SCOPE
46 - H2 PRINCIPLE
46 - H3 APPARATUS AND MATERIALS
46 - H3.1 For minimum loading
46 - H3.2 For maximum loading
46 - H4 PROCEDURE
46 - H4.1 Minimum load conditions
47 - H4.2 Maximum load
47 - H5 REPORT
50 - APPENDIX I - METHOD FOR DETERMINATION OF EXTERNAL SURFACE TEMPERATURE OF A DEEP FREEZE CABINET
50 - I1 SCOPE
50 - I2 PRINCIPLE
50 - I3 APPARATUS
50 - I4 TEST CONDITION
50 - I5 PROCEDURE
50 - I6 REPORT

Specifies requirements for the manufacture of medical refrigeration equipment such as reach-in cabinets and walk-in rooms for the storage of blood and blood products in the temperature range 2 degrees Celsius to 6 degrees Celsius, and for the storage of frozen blood plasma at a temperature of -25 degrees Celsius or lower, within an ambient temperature range of 10 degrees Celsius to 43 degrees Celsius.

This Standard specifies requirements for the manufacture of medical refrigeration equipment for the storage of blood and blood products within an ambient temperature range of 10¦C to 43¦C, as follows:(a) Blood and blood products in the temperature range 2¦C to 6¦C (see Sections 2 and 4).(b) Frozen blood plasma and plasma products at a temperature of -25¦C or lower (see Sections 3 and 5).The Standard covers refrigerated reach-in cabinets and walk-in rooms.NOTES:1 Where medical refrigeration equipment is intended to be used in an airconditioned atmosphere, only an ambient temperature range of 10¦C to 32¦C will be applicable for satisfying the requirements of this Standard, provided there is adequate standby electrical supply in case of power failure.2 Ultra-low temperature deep freeze cabinets are not dealt with in this Standard.3 Cognizance should be taken of any regulatory requirements and clinical practice pertaining to medical refrigeration equipment.

Draft Amendment 2 see DR 00105 CP First published as AS 3864-1991.Second edition 1997. First published as AS 3864-1991. Second edition 1997.