TDS PDF
Sterilization of health care products—Moist heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization Original standard AAMI ISO TIR17665-3-2014 (2016) in PDF full version. Additional info + preview on request
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Medical devices—Hierarchical coding structure for adverse events—Part 2- Evaluation codes Original standard AAMI ISO TIR19218-2-2012 in PDF full version. Additional info + preview on request
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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
Document status: Active