NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 14607 [available pre-publication] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-5 | 2009-06 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More |
| ISO 10993-6 | 2016-12 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation 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 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 21920-2 | 2021-12 | Geometrical product specifications (GPS) - Surface texture: Profile - Part 2: Terms, definitions and surface texture parameters More |
| ISO 48-4 | 2018-08 | Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by durometer method (Shore hardness) More |
| ISO/TS 10993-20 | 2006-08 | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices More |
| ASTM F 703 | 2018 | Standard Specification for Implantable Breast Prostheses 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 |
