NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 17664-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 11135 | 2014-07 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
| ISO 15883-4 | 2018-11 | Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More |
