NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 15883-2 [New] references following documents:

Document number Edition Title
EN 868-8 2018-12 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods More 
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 
IEC 61010-2-040 2020-05 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 11139 AMD 1 2024-01 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions More 
ISO 15883-4 2018-11 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More 
ISO/TS 5111 2022-12 Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products More