NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11608-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-1-9 AMD 2 | 2020-07 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design; Amendment 2 More |
| IEC 60601-1-9 Edition 1.1 | 2013-06 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design More |
| IEC 60601-1-9 Edition 1.2 | 2020-07 | Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design More |
| IEC 60601-2-24 | 2012-10 | Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers More |
| ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More |
| ISO 10993-15 | 2019-11 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More |
| ISO 10993-18 | 2020-01 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
| ISO 11040-8 | 2016-11 | Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes More |
