NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11607-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN 58953-8 | 2019-03 | Sterilization - Sterile supply - Part 8: Logistics of sterile 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 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 186 | 2002-03 | Paper and board - Sampling to determine average quality More |
| ISO 2859-1 | 1999-11 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More |
| ISO 9001 | 2015-09 | Quality management systems - Requirements More |
| ISO/TR 24971 | 2020-06 | Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) More |
