That FDA has issued Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. (2011).
That ANSI/AAMI/ ST 67:2011 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for product labeled "Sterile" is now available ?
That AAMI TIR 30:2011 is now available? A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
That ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process is now be available on the AAMI website?
That ANSI/AAMI/ISO 20857:2010 Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of an industrial sterilization process for medical devices is available ?
That AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers has been published ?
That FDA has issued Draft Guidance for Submission and Review of Sterility Information in 510k Submissions for Devices Labeled as Sterile ? It is available on the FDA website.
That AAMI TIR 14:2009 Contract sterilization using ethylene oxide, and AAMI TIR 28: Product adoption and process equivalence for EO sterilization are now available ?
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Are your validation protocols and SOPs up-to-date ?
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