NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 17664-1 [CURRENT] references following documents:
Document number | Edition | Title |
---|---|---|
ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 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 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards 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 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
ISO 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
ISO 15883-4 | 2018-11 | Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes More |
ISO 15883-5 | 2021-07 | Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy More |
ISO 15883-6 | 2011-04 | Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment More |
ISO 17664-2 | 2021-02 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices More |