Updates | Období : 01.01.2017 - 31.01.2017
Sector of : Active implantable medical devices (placed on the market to 26. 5. 2021)
| Standard code | ČSN | Description | Applicability date | Date of cessation of presumption of conformity of superseded standard | Publications in the Official Journal | Regulations |
|---|---|---|---|---|---|---|
| EN ISO 13485:2012 Canceled is replaced EN ISO 13485:2003Canceled EN ISO 13485:2016 | ČSN EN ISO 13485:2012Oprava 1-1.13Oprava 2-1.13Změna Z1-12.16(Canceled) is replaced ČSN EN ISO 13485 ed. 2:2016Změna A11-4.22Oprava 1-7.17 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | 31.08.2012 (AIMD) 31.08.2012 (MDD) 31.08.2012 (IVDD) | OJ-AIMD , OJ-MDD , OJ-IVDD | 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. | |
| AC:2012 |