EN 60601-2-33:2010
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis IEC 60601 IEC 60601-2-33:2010
| Status: | Harmonized EN 60601-2-33:2010 replaces EN 60601-2-33:2002 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN 60601-2-33:2010: | MDD | Medical devices (placed on the market to 26. 5. 2021) |
| Sphere of EN 60601-2-33:2010: | Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(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 |
| Notified bodies (NANDO): | Notified bodies for Council Directive 93/42/EEC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
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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/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197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repealed by 89/2021 Coll.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 |
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Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
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| Co-existence period end date: | 01.11.2019 (MDD) |
| Released: | August, 2019 |
Changes EN 60601-2-33:2010
| A12:2016 |
(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 |
|
| AC:2016-03 |
(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 |
|
|
A1:2015 IEC 60601-2-33:2010/A1:2013 |
(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 |
|
|
A1:2015 IEC 60601-2-33:2010/A1:2013 |
(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 |
|
|
A2:2015 IEC 60601-2-33:2010/A2:2015 |
(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 |
|
|
A2:2015 IEC 60601-2-33:2010/A2:2015 |
(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 |
ČSN
| ČSN EN 60601-2-33 ed. 3:2011 | replaces | ČSN EN 60601-2-33 ed. 2:2003 - Canceled | Note to ČSN EN 60601-2-33 ed. 3:2011: Nahrazena od 20.09.2027 ČSN EN IEC 60601-2-33 ed. 4 (364801) z listopadu 2024 |
| Změna A12-10.17 | |||
| Oprava 2-10.18 | |||
| Změna A2-4.16 | |||
| Změna A1-12.15 | |||
| Změna Z1-11.24 | |||
| Změna A11-9.12 | |||
| Oprava 1-10.18 |
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