Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

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AAMI

Reference21 articles.

1. ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

2. ISO 11139:2018 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards

3. ISO 14160 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization development validation and routine control of a sterilization process for medical devices

4. ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

5. AAMI TIR37 Sterilization of health care products — Radiation — Guidance on sterilization of biologics and tissue-based products

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