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AAMI/ISO 13408-3:2012 (R2015) Aseptic processing of health care products - Part 3: Lyophilization
AAMI/ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration
AAMI/ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements
AAMI/ISO 13408-1/A1:2013 (R2017) Aseptic processing of health care products - Part 1: General requirements
AAMI/ISO 13022:2012 Medical products containing viable human cells -- Application of risk management and requirements for processing practices
AAMI/ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
AAMI/ISO 11737-2:2009 (R2014) Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
AAMI/ISO 11737-1:2018 AAMI/ISO CDV-3 11737-1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product
AAMI/ISO 11658:2012 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
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 11607-1/A1:2014 (R2016) Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
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