NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14160 | 2020-09 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices More |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More |
| ISO 14644-7 | 2004-10 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) More |
| ISO 14937 | 2009-10 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 15882 | 2008-09 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results 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 17664-1 | 2021-07 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices More |
