Publications of NA 063-04-10 AA

CEN ISO/TS 11135-2/AC 2009-04 Pre-standard Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009) More  Order from Beuth Verlag
CEN ISO/TS 13004 2014-05 Pre-standard Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013) More  Order from Beuth Verlag
CEN ISO/TS 17665-2 2009-01 Pre-standard Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) More  Order from Beuth Verlag
DIN CEN ISO/TS 13004; DIN SPEC 13223:2014-10 2014-10 Technical Specification Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014 More  Order from Beuth Verlag
DIN EN 556-1 2002-03 Standards Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 More  Order from Beuth Verlag
DIN EN 556-1 Berichtigung 1 2006-12 Standards Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006 More  Order from Beuth Verlag
DIN EN 556-2 2015-11 Standards Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 More  Order from Beuth Verlag
DIN EN ISO 11135 2020-04 Standards Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More  Order from Beuth Verlag
DIN EN ISO 11137-1 2020-04 Standards Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More  Order from Beuth Verlag
DIN EN ISO 11137-2 2015-11 Standards Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015 More  Order from Beuth Verlag

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