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  • ANSI/AAMI/ISO 17664-1:2022

    Current The latest, up-to-date edition.

    Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  21-12-2022

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.

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

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

    AAMI TIR30:2011(R2016) A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
    ISO 11139:2018 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards
    AAMI TIR12:2020(R2023) Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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