NA 176
DIN Standards Committee Health Technologies
DIN EN 556-2 [New] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EN ISO 13408-3 | 2011-06 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) More |
| EN ISO 13408-4 | 2011-06 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) More |
| EN ISO 13408-6 | 2021-05 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) More |
| EN ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) More |
| EN ISO 15223-1 | 2021-09 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) More |
| EN 556-1 | 2024-07 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices 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 |
| ISO 13408-7 | 2012-08 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
