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  • AS 3864.2-2012

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    Medical refrigeration equipment - For the storage of blood and blood products User-related requirements for care, maintenance, performance verification and calibration

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  23-11-2012

    Publisher:  Standards Australia

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    Abstract - (Show below) - (Hide below)

    Specifies user-related requirements for the care, maintenance, performance verification and calibration of medical refrigeration equipment used 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.

    Scope - (Show below) - (Hide below)

    This Standard specifies user-related requirements for the care, maintenance, performance verification and calibration of medical refrigeration equipment used for the storage of the following:(a) Blood and blood products in the temperature range 2°C to 6°C.(b) Frozen plasma and plasma products at a temperature of ?25°C or lower.This Standard covers both reach-in cabinets and walk-in rooms. This Standard is intended to be read in conjunction with AS 3864.1. Where the term 'the Standard' is used it refers to both Parts 1 and 2 of AS 3864.NOTE: In some situations equipment that complies with the Standard may also be required to meet additional regulatory and/or clinical practice requirements. These requirements are outside the scope of the Standard.

    General Product Information - (Show below) - (Hide below)

    Committee HE-020
    Document Type Standard
    Publisher Standards Australia
    Status Current
    Supersedes

    History - (Show below) - (Hide below)

    Originated as part of AS 3864-1991.
    Previous edition part of AS 3864-1997.
    Revised in part and redesignated as AS 3864.2-2012. Originated as part of AS 3864-1991. Previous edition part of AS 3864-1997. Revised in part and redesignated as AS 3864.2-2012

    Standards Referenced By This Book - (Show below) - (Hide below)

    AS/NZS ISO 9001:2008 Quality management systems - Requirements
    AS/NZS ISO 9000.2:1998 Quality management and quality assurance Standards Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
    AS 3864.1-2012 Medical refrigeration equipment - For the storage of blood and blood products Manufacturing requirements
    AS ISO 15189-2009 Medical laboratories - Particular requirements for quality and competence
    AS/NZS ISO 9000:2006 Quality management systems - Fundamentals and vocabulary

    Standards Referencing This Book - (Show below) - (Hide below)

    AS 3864.1-2012 Medical refrigeration equipment - For the storage of blood and blood products Manufacturing requirements
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