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  • AAMI QSR : 1996

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  17-01-1996

    Language(s):  English

    Published date:  01-01-1996

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    Provides the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn

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

    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO 9001:2015 Quality management systems — Requirements
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