NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 10012 | 2003-04 | Measurement management systems - Requirements for measurement processes and measuring equipment More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 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 14644-13 | 2017-06 | Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications More |
| ISO 14644-14 | 2016-09 | Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration More |
| ISO 14644-15 | 2017-10 | Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration More |
