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DIN Standards Committee Health Technologies

DIN EN ISO 11737-2 [CURRENT] references following documents:

Document number Edition Title
EUV 2017/745 2017-04-05 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More 
EUV 2017/746 2017-04-05 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More 
ISO 10012 2003-04 Measurement management systems - Requirements for measurement processes and measuring equipment More 
ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 11138-2 2017-03 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes More 
ISO 11138-7 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 11737-1 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More