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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

60.60 Standard published

CEN/TC 206

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)

60.60 Standard published

CEN/TC 204

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

CEN/TC 204

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)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)

60.60 Standard published

CEN/TC 102

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

60.60 Standard published

CEN/TC 102

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

60.60 Standard published

CEN/TC 102

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)

60.60 Standard published

CEN/TC 102

Walking aids manipulated by both arms - Requirements and test methods - Part 3: Walking tables (ISO 11199-3:2005)

60.60 Standard published

CEN/TC 293

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

60.60 Standard published

CEN/TC 205

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)

60.60 Standard published

CEN/TC 205

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)

60.60 Standard published

CEN/TC 205

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60 Standard published

CEN/TC 102