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  • AS 3864-1997

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical refrigeration equipment - For the storage of blood and blood products

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  26-06-2021

    Language(s): 

    Published date:  01-01-1997

    Publisher:  Standards Australia

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee HE-020
    Document Type Standard
    Publisher Standards Australia
    Status Superseded
    Superseded By
    Supersedes
    Under Revision

    History - (Show below) - (Hide below)

    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.

    Standards Referenced By This Book - (Show below) - (Hide below)

    AS 1397-1993 Steel sheet and strip - Hot-dipped zinc-coated or aluminium/zinc-coated
    AS 1284.1-2004 Electricity metering General purpose induction watthour meters (Reconfirmed 2019)
    AS 3100-1990 Approval and test specification - General requirements for electrical equipment
    AS 1042-1973 Direct-acting indicating electrical measuring instruments and their accessories
    AS 1677-1986 Refrigerating systems
    AS 1627.0-1997 Metal finishing - Preparation and pretreatment of surfaces Method selection guide
    AS 1449-1994 Wrought alloy steels - Stainless and heat-resisting steel plate, sheet and strip
    AS 2171-1992 Guide to the manufacture of plastics items for food contact applications
    AS 1397-2001 Steel sheet and strip - Hot-dipped zinc-coated or aluminium/zinc-coated
    AS 1284.1-1991 Electricity metering General purpose induction watthour meters
    AS/NZS 3100:2002 Approval and test specification - General requirements for electrical equipment

    Standards Referencing This Book - (Show below) - (Hide below)

    AS 5388.1-2012 Forensic analysis Recognition, recording, recovery, transport and storage of material
    AS/NZS 61347.2.1:2002 Lamp controlgear Particular requirements for starting devices (other than glow starters)
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