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下载积分: 5000 积分
ANSI AAMI 13959-2014 Water for hemodialysis and related therapies.pdf
下载积分: 5000 积分
ANSI AAMI 13958-2014 Concentrates for hemodialysis and related therapies.pdf
下载积分: 5000 积分
ANSI AAMI 13485-2016 Medical devices - Quality management systems - Requirements for regulatory purposes.pdf
下载积分: 5000 积分
ANSI AAMI 13408-7-2012 Aseptic processing of health care products - Part 7 Alternative processes for medical devices and combination products.pdf
下载积分: 5000 积分
ANSI AAMI 13408-6-2005 Aseptic processing of health care products - Part 6 Isolator systems (Incorporates Amendment 1 2013).pdf
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ANSI AAMI 13408-5-2006 Aseptic processing of health care products - Part 5 Sterilization in place.pdf
下载积分: 5000 积分
ANSI AAMI 13408-4-2005 Aseptic processing of health care products - Part 4 Clean-in-place technologies.pdf
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ANSI AAMI 13408-3-2006 Aseptic processing of health care products - Part 3 Lyophilization.pdf
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ANSI AAMI 13408-2-2003 Aseptic processing of health care products - Part 2 Filtration.pdf
下载积分: 10000 积分
ANSI AAMI 13408-1-2008 Aseptic processing of health care products - Part 1 General requirements (Incorporates Amendment 1 2013).pdf
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ANSI AAMI 13022-2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices.pdf
下载积分: 5000 积分
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
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ANSI AAMI 11737-1-2006 Sterilization of health care products Microbiological methods Part 1 Determination of the population of microorganisms on product.pdf
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ANSI AAMI 11663-2014 Quality of dialysis fluid for hemodialysis and related therapies.pdf
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ANSI AAMI 11658-2012 Cardiovascular implants and extracorporeal systems - Blood tissue contact surface modifications for extracorporeal perfusion systems.pdf
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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
下载积分: 10000 积分
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
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ANSI AAMI 11195-1995 Gas mixers for medical use-Stand-alone gas mixers.pdf
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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
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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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ANSI AAMI 11140-3-2007 Sterilization of health care products - Chemical indicators - Part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test.pdf
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ANSI AAMI 11140-1-2014 Sterilization of health care products-Chemical indicators-Part 1 General requirements.pdf
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ANSI AAMI 11138-5-2017 Sterilization of health care products-Biological indicators-Part 5 Biological indicators for low-temperature steam and formaldehyde sterilization processes.pdf
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ANSI AAMI 11138-5-2006 Sterilization of health care products-Biological indicators-Part 5 Biological indicators for low-temperature steam and formaldehyde sterilization processes.pdf
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ANSI AAMI 11138-4-2017 Sterilization of health care products-Biological indicators-Part 4 Biological indicators for dry heat sterilization processes.pdf
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ANSI AAMI 11138-4-2006 Sterilization of health care products-Biological indicators-Part 4 Biological indicators for dry heat sterilization processes.pdf
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ANSI AAMI 11138-3-2017 Sterilization of health care products-Biological indicators-Part 3 Biological indicators for moist heat sterilization processes.pdf
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ANSI AAMI 11138-3-2006 Sterilization of health care products-Biological indicators-art 3 Biological indicators for moist heat sterilization processes.pdf
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ANSI AAMI 11138-2-2017 Sterilization of health care products-Biological indicators-Part 2 Biological indicators for ethylene oxide sterilization processes.pdf
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ANSI AAMI 11138-2-2006 Sterilization of health care products - Biological indicators - Part 2 Biological indicators for ethylene oxide sterilization processes.pdf
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ANSI AAMI 11138-1-2017 Sterilization of health care products-Biological indicators-Part 1 General requirements.pdf
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ANSI AAMI 11138-1-2006 Sterilization of health care products - Biological indicators - Part 1 General requirements.pdf
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ANSI AAMI 11137-3-2006 Sterilization of health care products-Radiation-Part 3 Guidance on dosimetric aspects.pdf
下载积分: 10000 积分
ANSI AAMI 11137-2-2013 Sterilization of health care products - Radiation - Part 2 Establishing the sterilization dose.pdf
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ANSI AAMI 11137-1-2006 Sterilization of health care products - Radiation - Part 1 Requirements for development validation and routine control of a sterilization process for medical.pdf
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ANSI AAMI 11135-2014 Sterilization of health care products - Ethylene oxide - Requirements for development validation and routine control of a sterilization process for medical dev.pdf
下载积分: 5000 积分
ANSI AAMI 10993-9-2009 Biological evaluation of medical devices - Part 9 Framework for identification and quantification of potential degradation products.pdf
下载积分: 10000 积分
ANSI AAMI 10993-7-2008 Biological evaluation of medical devices-Part 7 Ethylene oxide sterilization residuals.pdf
下载积分: 5000 积分
ANSI AAMI 10993-6-2016 Biological evaluation of medical devices-Part 6 Tests for local effects after implantation.pdf
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ANSI AAMI 10993-6-2007 Biological evaluation of medical devices - Part 6 Tests for local effects after implantation.pdf
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