NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11737-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More |
| 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 14644-12 | 2018-08 | Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration More |
| ISO 14644-16 | 2019-05 | Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices More |
| ISO 14644-2 | 2015-12 | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration More |
| ISO 14644-3 | 2019-08 | Cleanrooms and associated controlled environments - Part 3: Test methods 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 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 |
