AAMI
Association for the Advancement of Medical Instrumentation 1988 – 2024
Showing 1–16 of 342 results
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AAMI 11607 1 2019 A1 2023
ANSI/AAMI/ISO 11607-1:2019/A1:2023 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems…
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AAMI 11607 2 2019 A1 2023
ANSI/AAMI/ISO 11607-2:2019/A1:2023 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and…
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AAMI 13408 1 2023
ANSI/AAMI/ISO 13408-1:2023 Aseptic processing of health care products—Part 1: General requirements Published By Publication Date…
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AAMI TIR28:2016 R 2024
AAMI TIR28:2016/(R)2024 Product adoption and process equivalence for ethylene oxide sterilization Published By Publication Date…
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AAMI TIR15:2016 R 2024
AAMI TIR15:2016/(R)2024 Physical aspects of ethylene oxide sterilization Published By Publication Date Number of Pages…
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AAMI TIR14:2016 R 2024
AAMI TIR14:2016/(R)2024 Contract sterilization using ethylene oxide Published By Publication Date Number of Pages AAMI…
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AAMI TIR56:2013 R 2024
AAMI TIR56:2013/(R)2024 Guidance for the development, validation and routine control of an ethylene oxide sterilization…
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AAMI 20417 2021:2024 Edition
ANSI/AAMI/ISO 20417:2021 Medical devices Published By Publication Date Number of Pages AAMI 2024 94
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AAMI ST24 2024
ANSI/AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources…
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AAMI CR513 2024
AAMI CR513:2024 Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical…
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AAMI ST24 1999 RA 2018
ANSI/AAMI ST24:1999/(R)2018 – Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended…
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AAMI TIR34971 2023
AAMI TIR34971:2023 Application of ISO 14971 to machine learning in artificial intelligence Published By Publication…
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AAMI TIR99 2024
AAMI TIR99:2024 Processing of dilators, transesophageal and ultrasound probes in health care facilities Published By…
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AAMI TIR48 2024
AAMI TIR48:2024 – Quality Management System (QMS) guidance on compliance with FDA’s Final Rule on…
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AAMI 11140 6 2024
ANSI/AAMI/ISO 11140-6:2024 Sterilization of health care products Published By Publication Date Number of Pages AAMI…
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AAMI 11138 5 2017 R2024
ANSI/AAMI/ISO 11138-5:2017/(R)2024 – Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam…