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AAMI TIR52:2014(R2017) Environmental Monitoring For Terminally Sterilized Healthcare Products
AAMI STBK14-1:2014 Sterilization Pt 1: Sterilization in Health Care Facilities
AAMI/ISO 5841-2:2014 Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
AAMI/ISO 11607-1 AMD 1:2014 Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging
AAMI/ISO 11607-2 AMD 1:2014 (R2016) Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
AAMI/ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ANSI/AAMI/IEC 80601-2-58:2014 Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
AAMI/ISO 14708-1:2014 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
AAMI/ISO 11607-1/A1:2014 (R2016) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
AAMI TIR37:2013 Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
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