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Full Description

This standard covers the requirements to validate cleaning processes that are developed by the medical device manufacturer for processing medical devices. This document applies to all medical devices that require cleaning prior to each clinical use of that device. Clinical uses may be in health care facilities, home uses, or use by first responders, etc.

 

Document History

  1. AAMI ST98:2022

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    Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

    • Most Recent
  2. AAMI TIR30:2011/(R)2016


    A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

    • Historical Version
  3. AAMI TIR30:2003


    A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices

    • Historical Version