NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 25539-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-6 | 2016-12 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 10993-7 AMD 1 | 2019-12 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants More |
| ISO 10993-7 Technical Corrigendum 1 | 2009-11 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
| ISO 11135 | 2014-07 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
| ISO 11137-3 | 2017-06 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control 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 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
