NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 12417-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 5841-2 | 2014-08 | Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads More |
| ISO 7198 | 2016-08 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches More |
| ISO 8637-3 | 2024-05 | Extracorporeal systems for blood purification - Part 3: Plasmafilters More |
| ISO/IEC 17025 | 2017-11 | General requirements for the competence of testing and calibration laboratories More |
| ISO/TR 14283 | 2018-01 | Implants for surgery - Essential principles of safety and performance More |
| ISO/TR 37137 | 2014-05 | Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants More |
| ISO/TS 17137 | 2021-09 | Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants More |
| 2004/10/EG | 2004-02-11 | Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances More |
| 2004/9/EG | 2004-02-11 | Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) More |
