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AAMI 2800-1:2019 Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
AAMI/IEC 60601-2-4:2010/A1:2018 (Consolidated Text) Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
AAMI TIR38:2019 Medical device safety assurance case report guidance
AAMI/ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
AAMI/ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
AAMI SW91:2018 Classification of defects in health software
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