NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11608-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 7864 | 2016-12 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016); German version EN ISO 7864:2016 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 9626 | 2016-12 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016 More |
| DIN ISO 13926-2 | 2018-07 | Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use (ISO 13926-2:2017) 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 11137-1 | 2006-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 13926-2 | 2017-11 | Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use More |
| ISO 7000 ; ISO 7000-DB:2019-07 | 2019-07 | Graphical symbols for use on equipment - Registered symbols More |
