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  • AS 3864.1-2012

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

    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 requirements for the manufacture of medical refrigeration equipment used within an ambient temperature range of 10 degrees Celsius to 43 degrees Celsius 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 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 - (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 3864.1-2012. Originated as part of AS 3864-1991. Previous edition part of AS 3864-1997. Revised in part and redesignated as AS 3864.1-2012.

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

    AS/NZS 4417.2:2009 Marking of electrical and electronic products to indicate compliance with regulations
    AS 2070-1999 Plastics materials for food contact use
    AS/NZS 4417.1:2009 Marking of electrical and electronic products to indicate compliance with regulations
    AS/NZS 1677.1:1998 Refrigerating systems - Refrigerant classification
    AS 1397-2011 Continuous hot-dip metallic coated steel sheet and strip - Coatings of zinc and zinc alloyed with aluminium and magnesium
    AS 1627.0-1997 Metal finishing - Preparation and pretreatment of surfaces Method selection guide
    AS 3864.2-2012 Medical refrigeration equipment - For the storage of blood and blood products User-related requirements for care, maintenance, performance verification and calibration
    AS 60529-2004 Degrees of protection provided by enclosures (IP Code) (Reconfirmed 2018)
    AS/NZS 4417.2:2012 Regulatory compliance mark for electrical and electronic equipment Specific requirements for particular regulatory applications
    AS/NZS 4417.1:2012 Regulatory compliance mark for electrical and electronic equipment Use of the mark
    AS/NZS 3100:2009 Approval and test specification - General requirements for electrical equipment
    AS/NZS 1677.2:1998 Refrigerating systems - Safety requirements for fixed applications

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

    AS 3864.2-2012 Medical refrigeration equipment - For the storage of blood and blood products User-related requirements for care, maintenance, performance verification and calibration
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