EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
| Status: | Canceled EN ISO 13485:2012 is replaced EN ISO 13485:2016 EN ISO 13485:2003 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 13485:2012: | AIMD | Active implantable medical devices (placed on the market to 26. 5. 2021) MDD | Medical devices (placed on the market to 26. 5. 2021) IVDD | In vitro diagnostic medical devices (placed on the market to 26. 5. 2022) |
| Sphere of EN ISO 13485:2012: | Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 |
| Notified bodies (NANDO): | Notified bodies for Council directive 90/385/EEC Notified bodies for Council Directive 93/42/EEC Notified bodies for Directive EP and Council 98/79/EC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
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nařízení vlády č. 55/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
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Government Regulation SR No 167/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
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Council directive 90/385/EEC
/repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 |
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Council Directive 93/42/EEC
/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Recommendations (EU)2021/1433 wiil gradually expire Recommendations (EU)2020/403 / Recommendations (EU)2020/403 without Corrigendum / Commission Implementing regulation No (EU)2017/2185
/ Regulation Commission No 722/2012
/ Commission Desicion No 2010/227/EU / Agreement No 2017/2118
|
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|
nařízení vlády č. 54/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
||
|
Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
|
||
|
Directive EP and Council 98/79/EC
/ will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text with amendment (EU)2024/1860 / Commission Implementing regulation No (EU)2017/2185 / Commission Decision No 2008/932/ES, 2010/227/EC |
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| nariadenie vlády SR č. 569/2001 Z.z. (consolidated text) | ||
| nařízení vlády č. 56/2015 Sb. |
| Co-existence period end date: | 31.08.2012 (AIMD) 31.08.2012 (MDD) 31.08.2012 (IVDD) |
| Released: | August, 2012 |
Changes EN ISO 13485:2012
| AC:2012 |
(EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 , (EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 , (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 |
ČSN
| ČSN EN ISO 13485:2012 | is replaced | ČSN EN ISO 13485 ed. 2:2016 | Note to ČSN EN ISO 13485:2012: Nahrazena od 31.03.2019 ČSN EN ISO 13485 ed. 2 (855001) z prosince 2016 |
| Oprava 1-1.13 | |||
| Oprava 2-1.13 | |||
| Změna Z1-12.16 |
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