Annex II
United Kingdom
| No | Reference of the standard |
|---|---|
| 1. | EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
| 2. | EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 3. | EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
| 4. | EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2016 |