TDS PDF

Medical devices—Post-market surveillance for manufacturers Original standard AAMI ISO TIR20416-2020 in PDF full version. Additional info + preview on request

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Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release Original standard AAMI ISO TIR21387-2023 in PDF full version. Additional info + preview on request

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Guidance for uncertainty analysis regarding the application of ISO TS 10974 Original standard AAMI ISO TIR21900-2018 in PDF full version. Additional info + preview on request

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Medical devices utilizing animal tissues and their derivatives—Part 4- Principles for elimination and or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes Original standard AAMI ISO TIR22442-4-2011 (2016) in PDF full version. Additional info + preview on request

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Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products Original standard AAMI ISO TIR22456-2022 in PDF full version. Additional info + preview on request

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Medical devices—Guidance on the application of ISO 14971 Original standard AAMI ISO TIR24971-2020 in PDF full version. Additional info + preview on request

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