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

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AAMI

Reference83 articles.

1. AAMI TIR12:2010 Designing testing and labeling reusable medical devices for processing in health care facilities: A guide for medical device manufacturers. Association for the Advancement of Medical Instrumentation. Arlington VA.

2. AAMI TIR34:2014 (R2021) Water for the reprocessing of medical devices. Association for the Advancement of Medical Instrumentation. Arlington VA.

3. ANSI/AAMI ST72:2019 Bacterial endotoxin—Test methods routine monitoring and alternatives to batch testing. Association for the Advancement of Medical Instrumentation. Arlington VA.

4. ANSI/AAMI/ISO 10993-5:2009 (R2014) Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity. American National Standards Institute. Washington DC. Association for the Advancement of Medical Instrumentation. Arlington VA. International Organization for Standardization. Geneva Switzerland.

5. ISO 9000:2015 Quality management systems. International Organization for Standardization. Geneva Switzerland.

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