Abstract

Specifies requirements for the manufacture of medical refrigeration equipment used within an ambient temperature range of 10°C to 43°C for the storage of blood and blood products in the temperature range 2°C to 6°C and frozen plasma and plasma products at a temperature of -25°C or lower.

Scope

This Standard specifies requirements for the manufacture of medical refrigeration equipment used within an ambient temperature range of 10°C to 43°C (see Note 1) for the storage of the following:
(a) Blood and blood products in the temperature range 2°C to 6°C (see Sections 2 and 4);
(b) Frozen plasma and plasma products at a temperature of ?25°C or lower (see Sections 3 and 5) This Standard covers both reach-in cabinets and walk-in rooms. This Standard is intended to be read in conjunction with AS 3864.2. Where the term 'the Standard' is used it refers to both Parts 1 and 2 of AS 3864.
NOTES:
1 Where medical refrigeration equipment is intended to be used in an air-conditioned atmosphere, only the ambient temperature range of 10°C to 32°C will be applicable for satisfying the requirements of this Standard, provided there is an adequate back-up electrical supply in case of power failure.
2 In some situations equipment meeting the scope of the Standard may also be required to meet additional regulatory requirements. These requirements are outside the scope of the Standard.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
Pages
ISBN
Committee	HE-020
Supersedes	DR AS 3864 AS 3864-1997