EN ISO 17511:2021
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 17511:2021: | IVDR | In vitro diagnostic medical devices (IVDR) |
| Sphere of EN ISO 17511:2021: | Regulation No. 90/2016 - harmonized sphere (NLF) |
| Publications in the Official Journal: |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU) 2017/746 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Regulation (EU) 2017/746
consolidated text 2023 |
Regulation (EU) 2017/746
consolidated text
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 Act No 375/2022 Sb. applicable from 22. 12. 2022 Decree No 377/2022 Sb. applicable from 22. 12. 2022 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
Regulation (EU)2017/746
consolidated text
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
| Released: | January, 2022 |
ČSN
| ČSN EN ISO 17511 ed. 2:2021 |
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