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    Mission-Critical Medical

      Product Format Price Order   Ships In...  
    1. ISO 11607:2003 More Info
    01-Feb-2003
    Packaging for terminally sterilized medical devices - International Restrictions
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    2. ANSI/AAMI/ISO 13485:2003 (R2009) More Info
    18-Jun-2003
    Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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    PDF $100.00 Buy PDF Download
    Printed Edition $100.00 Buy H 24-48 Hours

    3. ANSI/AAMI/ISO 14791:2000/A1:2003 More Info
    26-Aug-2003 REPLACED by ANSI/AAMI/ISO 14971:2007 (R2010)
    Medical Devices - Application of Risk Management to Medical Devices
     
    PDF $90.00 Buy PDF Download
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    4. ANSI/AAMI/ISO 15223:2000 + Amendments 1 and 2 More Info
    REPLACED by ANSI/AAMI/ISO 15223-1:2007/(R)2012
    Medical devices-Symbols to be used with medical device labels, labeling,and information to be supplied.
     
    PDF $70.00 Buy PDF Download
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    5. ISO/IEC 17025:2005 More Info
    15-May-2005
    General requirements for the competence of testing and calibration laboratories
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    6. BS EN 980:2003 More Info
    13-Aug-2003 REPLACED by BS EN 980:2008
    Graphical symbols for use in the labelling of medical devices - International Restrictions
     
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    7. BS EN 1041:1998 More Info
    15-Jul-1998 REPLACED by BS EN 1041:2008
    Information supplied by the manufacturer with medical devices - International Restrictions
     
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