标准规范-国际标准-ANSI

ANSI AAMI 13959-2014 Water for hemodialysis and related therapies.pdf
ANSI AAMI 13958-2014 Concentrates for hemodialysis and related therapies.pdf
ANSI AAMI 13485-2016 Medical devices - Quality management systems - Requirements for regulatory purposes.pdf
ANSI AAMI 13408-7-2012 Aseptic processing of health care products - Part 7 Alternative processes for medical devices and combination products.pdf
ANSI AAMI 13408-6-2005 Aseptic processing of health care products - Part 6 Isolator systems (Incorporates Amendment 1 2013).pdf
ANSI AAMI 13408-5-2006 Aseptic processing of health care products - Part 5 Sterilization in place.pdf
ANSI AAMI 13408-4-2005 Aseptic processing of health care products - Part 4 Clean-in-place technologies.pdf
ANSI AAMI 13408-3-2006 Aseptic processing of health care products - Part 3 Lyophilization.pdf
ANSI AAMI 13408-2-2003 Aseptic processing of health care products - Part 2 Filtration.pdf
ANSI AAMI 13408-1-2008 Aseptic processing of health care products - Part 1 General requirements (Incorporates Amendment 1 2013).pdf
ANSI AAMI 13022-2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices.pdf
ANSI AAMI 11737-2-2009 Sterilization of medical devices C Microbiological methods C Part 2 Tests of sterility performed in the definition validation and maintenance of a sterilizat.pdf
ANSI AAMI 11737-1-2006 Sterilization of health care products Microbiological methods Part 1 Determination of the population of microorganisms on product.pdf
ANSI AAMI 11663-2014 Quality of dialysis fluid for hemodialysis and related therapies.pdf
ANSI AAMI 11658-2012 Cardiovascular implants and extracorporeal systems - Blood tissue contact surface modifications for extracorporeal perfusion systems.pdf
ANSI AAMI 11607-2-2006 Packaging for terminally sterilized medical devices-Part 2 Validation requirements for forming sealing and assembly processes (Incorporates Amendment 1 2014).pdf
ANSI AAMI 11607-1-2006 Packaging for terminally sterilized medical devices C Part 1 Requirements for materials sterile barrier systems and packaging (Incorporates Amendment 1 2014).pdf
ANSI AAMI 11195-1995 Gas mixers for medical use-Stand-alone gas mixers.pdf
ANSI AAMI 11140-5-2007 Sterilization of health care products Chemical indicators Part 5 Class 2 indicators for Bowie and Dick air removal test sheets and packs.pdf
ANSI AAMI 11140-4-2007 Sterilization of health care products Chemical indicators Part 4 Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetrati.pdf
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