NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 8637-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-2-16 | 2018-04 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment More |
| ISO 10993-11 | 2017-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More |
| ISO 10993-4 | 2017-04 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 11737-2 | 2019-12 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process More |
| ISO 20417 | 2021-04 | Medical devices - Information to be supplied by the manufacturer More |
| ISO 7864 | 2016-08 | Sterile hypodermic needles for single use - Requirements and test methods More |
| ISO 80369-7 | 2021-05 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications More |
| DIN EN IEC 60601-2-16 ; VDE 0750-2-16:2020-05 | 2020-05 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018); German version EN IEC 60601-2-16:2019 More |
