NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 17664-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| DIN EN ISO 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 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 15883-6 | 2016-04 | Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2015 More |
| DIN EN ISO 15883-7 | 2016-10 | Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016); German version EN ISO 15883-7:2016 More |
| DIN EN ISO 20857 | 2013-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 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 |
