AS 3864—1997

Australian Standard
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Medical refrigeration equipment—

For the storage of blood and blood
products
 This Australian Standard was prepared by Committee HT/10, Medical Refrigeration.
It was approved on behalf of the Council of Standards Australia on 14 March 1997
and published on 5 August 1997.
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

The following interests are represented on Committee HT/10:

Australian Hospital Association
Australian Institute of Refrigeration, Air Conditioning and Heating
Australian Red Cross Society
Commercial Refrigeration Manufacturers Association of Australia
Commonwealth Department of Health and Family Services
Commonwealth Serum Laboratories
Institute of Medical and Veterinary Science
N.S.W Health Department
Queensland Health
Royal College of Pathologists of Australasia

Review of Australian Standards. To keep abreast of progress in industry, Australi an Standards are subject
to periodic review and are kept up to date by the issue of amendments or new editions as necessary. It is
important therefore that Standards users ensure that they are in possession of the latest edition, and any
amendments thereto.
Full details of all Australian Standards and related publications will be found in the Standards Australia
Catalogue of Publications; this informati on is supplemented each month by the magazine ‘The Australian
Standard’, which subscribing members receive, and which gives details of new publications, new editi ons
and amendments, and of wit hdrawn Standards.
Suggestions for improvements to Australian Standards, addressed to the head office of Standards Australia,
are welcomed. Notification of any inaccuracy or ambiguity found in an Australian Standard should be made
without delay in order that the matter may be investigated and appropriate acti on taken.

This Standard was issued in draft form for comment as DR 95428.

 AS 3864—1997

Australian Standard
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Medical refrigeration equipment—

For the storage of blood and blood
products

Originated as AS 3864— 1991.

Second edition 1997.

Incorporating:
Amdt 1—1998

PUBLISHED BY STANDARDS AUSTRALIA

(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7337 1151 0
 AS 3864— 1997 2

PREFACE

This Standard was prepared by the Standards Australia Committee HT/10, Medical
Refrigeration, to supersede AS 3864 —1991, Medical refrigeration equipment — For the
storage of blood and blood products, and containers for the transport of blood and blood
products .
In the preparation of this Standard, account has been taken of testing conducted by the
N.S.W. Red Cross Society Blood Transfusion Service.
Whilst this Standard specifies test methods, other methods which have been demonstrated
to produce equivalent or comparable results, are acceptable.
As this Standard deals with the manufacture of new medical refrigeration equipment,
existing equipment may not meet all aspects of this Standard.
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

The objective of this Standard is to ensure that blood and blood products can be safely
stored at pre-determined temperatures prior to use in patients.
The term ‘normative’ has been used in this Standard to define the application of the
appendix to which it applies. A ‘normative’ appendix is an integral part of a Standard.
The principal differences between this edition and the 1991 edition are as follows:
(a) A temperature not warmer than −25°C is specified for the storage of plasma
products, and a broader temperature range of 2°C to 6°C is specified for the storage
of blood and blood products.
(b) The alarms are to activate if the temperature of the lagged probe falls to 2.5°C or
reaches 5.5°C for the storage of red cells, or rises to −27°C for the storage of
plasma. In practice, it would mean that alarms would activate within the accepted
temperature range.
(c) Lagging material for temperature probes of recording systems of freezers and
freezer rooms has been changed to the thermal capacity equivalent to 100 ±10 g of
ice. The use of aluminium cylinders as suitable lagging material has been
incorporated.
(d) The operation test for cabinets (Appendices D and H) may be performed at ambient
temperatures of 10°C and 32°C only.

 Copyri ght STANDARDS AUSTRALIA

Users of Standards are reminded that copyright subsists in all Standards Austr alia publications and software. Except where the
Copyri ght Act allows and except where provided for below no publications or soft ware produced by Standards Austr alia may be
reproduced, stored in a retri eval system in any form or transmitt ed by any means wit hout prior permission in wri ti ng from
Standards Australi a. Permission may be conditi onal on an appropriate royalt y payment. Requests for permission and information
on commercial software royalt ies should be directed to the head offi ce of Standards Austr alia.
Standards Austr alia wil l permit up to 10 percent of the technical content pages of a Standard to be copied for use
exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Austr alia.
Standards Austr alia will also permit the inclusion of its copyri ght materi al in computer software programs for no royalt y
payment provided such programs are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is from the curr ent edit ion of the Standard and that it is updated whenever the
Standard is amended or revised. The number and date of the Standard should therefore be clearly identif ied.
The use of materi al in pri nt form or in computer soft ware programs to be used commercially, with or wit hout payment, or in
commercial contracts is subject to the payment of a royalty. This policy may be vari ed by Standards Austr alia at any ti me.
 3 AS 3864 — 1997

CONTENTS
Page

SECTION 1 SCOPE AND GENERAL

1.1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . .. . .. . .. .. .. .. ... ... ..... 5
1.2 REFERENCED DOCUMENTS . . . . . . . .. .. . .. . ............ ... .. 5
1.3 DEFINITIONS . . . . . . . . . . . . . . . . . . . .. ... . .. .. .. ... ... .. ..... 6
1.4 ELECTRICAL SAFETY . . . . . . . . . . . . .. ... ... ....... ... .. .. .. . 6
1.5 CARE AND MAINTENANCE . . . . . . . .. .. . .. . ............ ... .. 6
1.6 MARKING . . . . . . . . . . . . . . . . . . . . . .. ... . .. . .. .. .. .. ... ..... 6

SECTION 2 SELF-CONTAINED REFRIGERATION EQUIPMENT FOR THE

STORAGE OF BLOOD AND BLOOD PRODUCTS IN THE
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

TEMPERATURE RANGE 2°C TO 6°C

2.1 SCOPE OF SECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.2 CONSTRUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3 LIGHTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.4 REFRIGERATION SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 GENERAL CONDITIONS OF TESTING . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.6 PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.7 INSTRUMENTS AND TEMPERATURE MEASURING APPARATUS . . . . 9
2.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER . . . . . . . 10

SECTION 3 SELF-CONTAINED REFRIGERATION EQUIPMENT FOR THE

STORAGE OF BLOOD PLASMA AND PLASMA PRODUCTS AT
OR BELOW −25°C
3.1 SCOPE OF SECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.2 CONSTRUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.3 REFRIGERATION SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.4 GENERAL CONDITIONS OF TESTING . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.5 PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.6 INSTRUMENTS AND TEMPERATURE CONTROL APPARATUS . . . . . . 14
3.7 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER . . . . . . . 15

SECTION 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2 CONSTRUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.3 LIGHTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.4 REFRIGERATION SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.5 GENERAL CONDITIONS OF TESTING . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.6 PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.7 INSTRUMENTS AND TEMPERATURE MONITORING APPARATUS . . . 19
4.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER . . . . . . . 20
 AS 3864— 1997 4

Page

SECTION 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.2 CONSTRUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.3 LIGHTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.4 REFRIGERATION SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.5 GENERAL CONDITIONS OF TESTING . . . . . . . . . . . . . . . . . . . . . . . . 24
5.6 PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7 INSTRUMENTS AND TEMPERATURE MONITORING APPARATUS . . 25
5.8 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER . . . . . . 26

APPENDICES
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

A CARE AND MAINTENANCE OF REFRIGERATION EQUIPMENT . . . . . . 28

B GENERAL TEST CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
C METHOD FOR DETERMINING EXTERNAL SURFACE TEMPERATURE
OF A REFRIGERATION CABINET MAINTAINED IN
THE TEMPERATURE RANGE 2°C TO 6°C . . . . . . . . . . . . . . . . . . . . . . . 31
D OPERATION TEST FOR A REFRIGERATION CABINET FOR THE
STORAGE OF BLOOD AND BLOOD PRODUCTS IN THE
TEMPERATURE RANGE 2°C TO 6°C . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
E METHOD FOR DETERMINATION OF SERVICE LOAD CAPACITY
OF A REFRIGERATION CABINET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
F METHOD FOR DETERMINATION OF HEAT INSULATING CAPACITY
OF A REFRIGERATION CABINET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
G METHOD FOR TESTING TEMPERATURE RECORDER AND
ALARM SYSTEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
H OPERATION TEST FOR A DEEP FREEZE CABINET . . . . . . . . . . . . . . . 44
I METHOD FOR DETERMINATION OF EXTERNAL SURFACE
TEMPERATURE OF A DEEP FREEZE CABINET . . . . . . . . . . . . . . . . . . 48
 5 AS 3864 — 1997

STANDARDS AUSTRALIA

Australian Standard
Medical refrigeration equipment—For the storage of
blood and blood products

S E C T I O N 1 S CO P E A N D G E NE R A L

1.1 SCOPE 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:
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

(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.

1.2 REFERENCED DOCUMENTS The following documents are referred to in this

Standard:
AS
1042 Direct-acting indicating electrical measuring instruments and their accessories
1284 Electricity meters
1284.1 Part 1: General purpose watthour meters
1397 Steel sheet and strip —Hot-dipped zinc-coated or aluminium/zinc-coated
1449 Wrought alloy steels —Stainless and heat-resisting steel plate, sheet and strip
1627 Metal finishing— Preparation and pretreatment of surfaces
1627.0 Part 0: Method selection guide for preparation and pretreatment of steel
surfaces
1677 Refrigerating systems
2171 Code of practice for the manufacture of plastics items for food contact
applications
3100 Approval and test specification —Definitions and general requirements for
electrical materials and equipment
ISO
R916 Testing of refrigerating systems

COPYRIGHT
 This is a free preview. Purchase the entire publication at the link below:

AS 3864-1997, Medical refrigeration equipment -

For the storage of blood and blood products
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Looking for additional Standards? Visit SAI Global Infostore

Subscribe to our Free Newsletters about Australian Standards® in Legislation; ISO, IEC, BSI and more
Do you need to Manage Standards Collections Online?
Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation
Do you want to know when a Standard has changed?
Want to become an SAI Global Standards Sales Affiliate?

Learn about other SAI Global Services:

LOGICOM Military Parts and Supplier Database

Metals Infobase Database of Metal Grades, Standards and Manufacturers
Materials Infobase Database of Materials, Standards and Suppliers
Database of European Law, CELEX and Court Decisions

Need to speak with a Customer Service Representative - Contact Us