NA 176

DIN Standards Committee Health Technologies

DIN ISO 21881 [CURRENT] references following documents:

Document number Edition Title
ISO 11140-3 Technical Corrigendum 1 2007-11 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; Technical Corrigendum 1 More 
ISO 11140-4 2007-03 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 More 
ISO 11140-5 2007-03 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests More 
ISO 11607-1 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More 
ISO 720 2020-09 Glass - Hydrolytic resistance of glass grains at 121 °C - Method of test and classification More 
ISO 8871-1 2003-10 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates More 
DIN EN ISO 11135 2020-04 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 
DIN EN ISO 11137-1 2020-04 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 
DIN EN ISO 11137-3 2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More 
DIN EN ISO 11138-1 2017-07 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017 More