NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-6 [available pre-publication] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ASTM F 763 | 2022 | Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials More |
| ASTM F 981 | 2023 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in 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 |
| ISO 10993-11 | 2017-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More |
| ISO 11979-5 | 2020-09 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility More |
| ISO 13781 | 2017-07 | Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing More |
| ISO 14708-1 | 2014-08 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer More |
| ISO 14708-2 | 2019-09 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers More |
| ISO 14708-3 | 2017-04 | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators More |
| ISO 14708-4 | 2022-02 | Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems More |
