AS 3864:1997
$43.55
Medical refrigeration equipment – For the storage of blood and blood products
Published By | Publication Date | Number of Pages |
AS | 1997-08-05 | 51 |
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°C to 6°C, and for the storage of frozen blood plasma at a temperature of -25°C or lower, within an ambient temperature range of 10°C to 43°C.
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:
(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.