NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [Withdrawn] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes 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 15882 | 2008-09 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results 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 18362 | 2016-02 | Manufacture of cell-based health care products - Control of microbial risks during processing More |
| ISO 18472 | 2018-08 | Sterilization of health care products - Biological and chemical indicators - Test equipment More |
| ISO 20857 | 2010-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
