NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 15798 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 10993-16 | 2018-02 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 More |
| DIN EN ISO 10993-9 | 2022-03 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021 More |
| DIN EN ISO 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More |
| DIN EN ISO 11137-1 | 2020-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More |
| DIN EN ISO 11137-3 | 2017-11 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 22442-1 | 2021-08 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 More |
| DIN EN ISO 22442-2 | 2021-04 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020 More |
| DIN EN ISO 22442-3 | 2008-03 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 More |
| ISO 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
