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Full Description

Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, disinfection and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided, as are a bibliography and other informative annexes
 

Document History

  1. AAMI TIR 12:2020/(R)2023


    Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

    • Most Recent
  2. AAMI TIR12:2010


    Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

    • Historical Version
  3. AAMI TIR12:2004

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    Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

    • Historical Version
  4. AAMI TIR 12-94


    Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Manufacturers

    • Historical Version