AS 3864.1-2012
AS 3864.1-2012
Medical refrigeration equipment - For the storage of blood and blood products Manufacturing requirements
Standards Australia
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
| Document Type | Standard |
| Status | Current |
| Publisher | Standards Australia |
| Committee | HE-020 |
| Supersedes |
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