NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11608-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
| ISO 11608-2 | 2022-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles More |
| ISO 11608-3 | 2022-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths More |
| ISO 11608-4 | 2022-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics More |
| ISO 11608-5 | 2022-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions More |
| ISO 11608-6 | 2022-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems More |
| ISO 11608-7 | 2016-08 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14253-1 | 2017-10 | Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for verifying conformity or nonconformity with specifications More |
