NA 176

DIN Standards Committee Health Technologies

DIN EN 868-5 [CURRENT] references following documents:

Document number Edition Title
EN 868-10 2018-12 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods More 
EN 868-9 2018-12 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods More 
EN ISO 11140-1 2014-11 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) More 
EN ISO 14937 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) More 
EN 1422 2014-05 Sterilizers for medical purposes - Ethylene oxide sterilizers - 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