2014-05
On May 16, 2014 the EU Commission has published some new / updated harmonized standards for the 93/42/EEC (MDD).
Product, which conform to harmonized standards, are presumed to comply with the essential requirements in the Medical Device Directives.
The updates of horizontal standards, include a.o.:
| Ref. | Desription | In force: |
|---|---|---|
| EN ISO 11137-1:2006/A1:2013 | Sterilization of health care products – Radiation | 2014-11-30 |
| EN ISO 11137-2:2013 | Sterilization of health care products – Radiation | 2014-11-30 |
| EN ISO 13408-1:2011/A1:2013 | Aseptic processing of health care products | 2014-11-30 |
| EN 60601-1:2006/A1:2013 | Medical electrical equipment | 2017-12-31 |
All harmonized standards you find here:
