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AS 3864.1-2012
[Pending Revision]Medical refrigeration equipment - For the storage of blood and blood products, Part 1: Manufacturing requirements
Specifies requirements for the manufacture of medical refrigeration equipment used within an ambient temperature range of 10 degrees Celsius to 43 degrees Celsius for the storage of blood and blood products in the temperature range 2 degrees Celsius to 6 degrees Celsius and frozen plasma and plasma products at a temperature of minus 25 degrees Celsius or lower.
Published: 23/11/2012
Pages: 51
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
1 Scope and general
1.1 Scope
1.2 Referenced documents
1.3 Definitions
1.4 Electrical safety
1.5 Care and maintenance
1.6 Marking
1.6.1 General
1.6.2 Cabinet
1.6.3 Refrigerated room
2 Self-contained refrigeration equipment for the storage of blood and blood products in the temperature range 2°C to 6°C
2.1 Scope of section
2.2 Construction
2.2.1 External finish
2.2.2 Thermal insulation
2.2.3 Internal finish
2.2.4 Shelves, drawers and partitions
2.2.5 Pressure relief devices
2.2.6 Doors and lids
2.2.7 Access
2.2.8 Levelling screws or castors
2.2.9 Load limits
2.3 Lighting
2.3.1 General
2.3.2 Lamps and lamp holders
2.4 Refrigeration systems
2.4.1 General
2.4.2 Noise
2.4.3 Ice-free operation
2.4.4 Forced draught systems
2.4.5 Security of refrigeration controller
2.5 General conditions of testing
2.6 Performance requirements
2.6.1 Air circulation and temperature distribution
2.6.2 External surface temperature
2.6.3 Operation
2.6.4 Service load capacity
2.6.5 Power consumption
2.6.6 Compressor operating time
2.6.7 Maximum cycling frequency
2.6.8 Heat insulating capacity
2.7 Information to be supplied by the manufacturer
3 Self-contained refrigeration equipment for the storage of blood plasma and plasma products at or below −25°C
3.1 Scope of section
3.2 Construction
3.2.1 External finish
3.2.2 Thermal insulation
3.2.3 Internal finish
3.2.4 Shelves, drawers and partitions
3.2.5 Pressure relief devices
3.2.6 Lids and doors
3.2.6.1 For chest type
3.2.6.2 For upright type
3.2.6.3 Prevention of icing of door gasket
3.2.7 Access
3.2.8 Levelling screws/castors
3.2.9 Load limits
3.3 Lighting
3.3.1 General
3.3.2 Lamps and lamp holders
3.4 Refrigeration system
3.4.1 General
3.4.2 Static system
3.4.3 Forced draught system
3.4.4 Ice-free operation
3.4.5 Noise
3.4.6 Refrigeration control device
3.5 General conditions of testing
3.6 Performance requirements
3.6.1 Air circulation and temperature distribution
3.6.2 Product temperature
3.6.3 Power consumption
3.6.4 Operation
3.6.5 External surface temperature
3.6.6 Compressor operating time
3.6.7 Maximum cycling frequency
3.6.8 Heat insulating capacity
3.6.9 Service load capacity
3.7 Information to be supplied by the manufacturer
4 Walk-in type coolrooms for the storage of blood and blood products in the temperature range 2°C to 6°C
4.1 Scope of section
4.2 Construction
4.2.1 General
4.2.2 Crash barriers
4.2.3 Joints
4.2.4 External finish
4.2.5 Thermal insulation
4.2.6 Internal finish
4.2.6.1 Walls and ceiling
4.2.6.2 Flooring
4.2.7 Windows
4.2.8 Pressure relief devices
4.2.9 Shelves and partitions
4.2.10 Air distribution devices
4.2.11 Doors
4.2.12 Defrost and condensate drainpipes
4.2.13 Load limits
4.3 Lighting
4.3.1 General
4.3.2 Lamps and lampholders
4.4 Refrigeration system
4.4.1 General
4.4.2 Ice-free operation
4.4.3 Air circulation
4.4.4 Noise
4.4.5 Refrigeration plant and controller
4.5 General conditions of testing
4.6 Performance requirements
4.6.1 External surface temperature of coolroom
4.6.2 Blood pack temperature
4.6.3 Compressor operating time
4.6.4 Maximum cycling frequency
4.6.5 Heat insulating capacity
4.7 Information to be supplied by the manufacturer
5 Walk-in type freezer rooms for the storage of blood plasma and plasma products at or below −25°C
5.1 Scope of section
5.2 Construction
5.2.1 General
5.2.2 Crash barriers
5.2.3 Joints
5.2.4 External finish
5.2.5 Thermal insulation
5.2.6 Internal finish
5.2.6.1 Walls and ceiling
5.2.6.2 Flooring
5.2.7 Windows
5.2.8 Pressure relief device
5.2.9 Shelves and partitions
5.2.10 Air distribution devices
5.2.11 Doors
5.2.12 Defrost and condensate drainpipes
5.2.13 Load limits
5.3 Lighting
5.3.1 General
5.3.2 Lamps and lampholders
5.4 Refrigeration system
5.4.1 General
5.4.2 Ice-free operation
5.4.3 Air circulation
5.4.4 Noise
5.4.5 Refrigeration plant and controller
5.5 General conditions of testing
5.6 Performance requirements
5.6.1 External surface temperature of freezer room
5.6.2 Plasma pack temperature
5.6.3 Compressor operating time
5.6.4 Maximum cycling frequency
5.6.5 Heat insulating capacity
5.7 Information to be supplied by the manufacturer
6 Temperature recording and alarm systems
6.1 Instruments and temperature measuring apparatus
6.1.1 General
6.1.2 Temperature sensor
6.1.3 Chart recorders
6.1.4 Electronic temperature monitoring system
6.1.5 Electronic monitoring system of equipment located at remote sites
6.2 Alarm systems
6.2.1 General
6.2.2 Independent operation of refrigeration control and alarm systems
6.2.3 Thermal lagging
Appendix A
A1 Scope
A2 General
A3 Test room
A3.1 General
A3.2 Measurement of ambient temperature
A3.3 Temperature distribution
A3.4 Temperature conditions
A4 Measuring instruments
A4.1 Temperature-measuring instruments
A4.2 Electrical instruments
A5 Preparation for testing
A6 Operating requirements for the cabinet or room
A7 Electric power supply
A8 Stable operating conditions
Appendix B
B1 Scope
B2 Principle
B3 Apparatus
B4 Test condition
B5 Preparation of the cabinet
B6 Procedure
B7 Report
Appendix C
C1 Scope
C2 Principle
C3 Apparatus and materials
C3.1 For minimum loading
C3.2 For maximum loading
C4 Procedure
C4.1 General
C4.2 Minimum load
C4.3 Maximum load
C5 Report
Appendix D
D1 Scope
D2 Principle
D3 Apparatus
D4 Preparation of the cabinet
D5 Test procedure
D6 Calculation
D7 Report
Appendix E
E1 Scope
E2 Principle
E3 Apparatus
E4 Procedure
E5 Report
Appendix F
F1 Scope
F2 Principle
F3 Apparatus and materials
F3.1 For minimum loading
F3.2 For maximum loading
F4 Procedure
F4.1 Minimum load conditions
F4.2 Maximum load
F5 Report
Appendix G
G1 Scope
G2 Principle
G3 Apparatus
G4 Test condition
G5 Procedure
G6 Report
Appendix H
H1 Scope
H2 Principle
H3 Apparatus
H4 Procedure
H4.1 For refrigerators and coolrooms maintained in temperature range 2°C to 6°C
H4.1.1 Integrated alarm and temperature recording device
H4.1.1.1 Test for accuracy of the temperature recording device
H4.1.1.2 Test for alarm activation at the upper permissible temperature limit
H4.1.1.3 Test for alarm activation at the lower permissible temperature limit
H4.1.2 Separate alarm and temperature recording device
H4.1.2.1 Test for the accuracy of the temperature recording device
H4.1.2.2 Test for accuracy of the temperature recording device at ice point
H4.1.2.3 Test for accuracy of the digital temperature display (if fitted)
H4.1.2.4 Test for alarm activation at the upper permissible temperature limit
H4.1.2.5 Test for alarm activation at the lower permissible temperature limit
H4.2 For freezers and freezer rooms maintained at −25°C or lower
H4.2.1 Integrated alarm and temperature recording device
H4.2.1.1 Test for accuracy of the temperature recording device
H4.2.1.2 Test for alarm activation at −27°C
H4.2.2 Separate alarm and temperature recording device
H4.2.2.1 Test for the accuracy of the temperature recording device
H4.2.2.2 Test for accuracy of the digital temperature display (if fitted)
H4.2.2.3 Test for alarm activation at the upper permissible temperature limit
H4.3 Power failure alarm test
H4.4 Aural alarm reactivation test
H4.5 Remote alarm terminal test
H5 Report
Cited references in this standard
ISO R 916
Testing of refrigerating systems
[Current]
Continuous hot-dip metallic coated steel sheet and strip - Coatings of zinc and zinc alloyed with aluminium and magnesium
[Current]
Metal finishing — Preparation and pretreatment of surfaces, Part 0: Method selection guide
[Pending Revision]
Medical refrigeration equipment - For the storage of blood and blood products, Part 2: User-related requirements for care, maintenance, performance verification and calibration
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