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DIN Standards Committee Health Technologies

DIN EN ISO 80369-7 [CURRENT] references following documents:

Document number Edition Title
IEC 62366-1 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 80369-1 2018-11 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements More 
DIN EN ISO 80369-1 2019-08 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018); German version EN ISO 80369-1:2018 More 
DIN EN ISO 80369-6 2018-10 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15); German version EN ISO 80369-6:2016 More 
DIN EN ISO 8536-4 2020-05 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019); German version EN ISO 8536-4:2020 More 
DIN EN ISO 8637-1 2020-10 Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017); German version EN ISO 8637-1:2020 More 
DIN EN 80369-5 2017-10 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications (IEC 80369-5:2016 + Cor. 1:2017); German version EN 80369-5:2016 + AC:2017 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 60601-1 Edition 3.1 2012-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More