NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 17664-2 [CURRENT] references following documents:

Document number Edition Title
EN 16442 2015-03 Controlled environment storage cabinet for processed thermolabile endoscopes 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 62366-1 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices More 
ISO 15883-4 2018-11 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More 
ISO 15883-5 2021-07 Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy More 
ISO 15883-6 2011-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment More 
ISO 17664-1 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices More 
ISO 20417 2021-04 Medical devices - Information to be supplied by the manufacturer More