NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13408-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 18362 | 2018-11 | Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 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 29463-5 | 2022-10 | High-efficiency filters and filter media for removing particles in air - Part 5: Test method for filter elements (ISO 29463-5:2022); German version EN ISO 29463-5:2022 More |
| DIN EN ISO 5667-13 | 2011-08 | Water quality - Sampling - Part 13: Guidance on sampling of sludges (ISO 5667-13:2011); German version EN ISO 5667-13:2011 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 |
| DIN EN 17141 | 2021-02 | Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020 More |
| DIN EN 61882 ; VDE 0050-8:2017-02 | 2017-02 | Hazard and operability studies (HAZOP studies) - Application guide (IEC 61882:2016); German version EN 61882:2016 More |
| EN 1822-1 | 2019-04 | High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking 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 |
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
