NA 176

DIN Standards Committee Health Technologies

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

Document number Edition Title
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ASTM D 8179 2018 Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices More 
DIN EN ISO 14971 2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More 
DIN EN ISO 15883-4 2019-06 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018); German version EN ISO 15883-4:2018 More 
DIN EN ISO 15883-5 2021-11 Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021); German version EN ISO 15883-5:2021 More 
DIN EN ISO 17664-1 2021-11 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 (ISO 17664-1:2021); German version EN ISO 17664-1:2021 More 
DIN EN ISO 20417 2022-03 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021 More 
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 2021-08 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More 
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