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  • AAMI ST72 : 2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-12-2019

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Quality management system elements
    5 Non-pyrogenic labeling
    6 Selection of product units
    7 Selection of technique
    8 Validation of methodology
    9 Use of technique
    10 Alternatives to batch testing
    Annex A - Background on the bacterial endotoxins test
    Annex B - Guidance on test methods, routine monitoring, and
              alternatives to batch testing
    Annex C - Guidance on out of specification (OOS) and failure
              investigation
    Annex D - Bibliography

    Abstract - (Show below) - (Hide below)

    Describes general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials using bacterial endotoxin test methods.

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

    Committee WG 08
    Document Type Standard
    Product Note Reconfirmed 2011
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI ISO TIR 11139 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
    ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
    ASTM D 7102 : 2017 : REDLINE Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
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