NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11608-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 11608-2 | 2022-09 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022); German version EN ISO 11608-2:2022 More |
| DIN EN ISO 11608-4 | 2022-09 | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022); German version EN ISO 11608-4:2022 More |
| DIN EN ISO 11608-7 | 2017-10 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German version EN ISO 11608-7:2017 More |
| DIN EN ISO 13485 | 2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More |
| DIN EN ISO 14253-1 | 2018-07 | Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for verifying conformity or nonconformity with specifications (ISO 14253-1:2017); German version EN ISO 14253-1:2017 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 23908 | 2013-10 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2013 More |
| DIN EN ISO 9001 | 2015-11 | Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More |
| DIN EN ISO/IEC 17025 | 2018-03 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More |
