NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 15378 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11137-1 | 2006-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14001 | 2015-09 | Environmental management systems - Requirements with guidance for use More |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration 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 14644-5 | 2004-08 | Cleanrooms and associated controlled environments - Part 5: Operations 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 37500 | 2014-11 | Guidance on outsourcing More |
