EN 60601-2-28:2010 (IEC 60601-2-28:2010)
Medical electrical equipment -- Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
| Status: | Harmonized EN 60601-2-28:2010 replaces EN 60601-2-28:1993 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN 60601-2-28:2010: | MDD | Medical devices (placed on the market to 26. 5. 2021) |
| Sphere of EN 60601-2-28:2010: | 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 |
|---|---|---|
|
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/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197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
|
||
|
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repealed by 89/2021 Coll.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// 25. 5. 2021 repealed by No 362/2011 Coll.
|
| Co-existence period end date: | 01.04.2013 (MDD) |
| Released: | January, 2011 |
Note
Tato evropská norma nemusí nutně zahrnovat požadavky zavedené směrnicí 2007/47/ES.
ČSN
| ČSN EN 60601-2-28 ed. 2:2010 | Note to ČSN EN 60601-2-28 ed. 2:2010: Nahrazena od 7.08.2022 ČSN EN IEC 60601-2-28 ed. 3 (364801) z prosince 2019 | ||
| Změna Z1-12.19 |
Customers who have agreed on their computer from ÚNMZ service CSN on-line-for electronic access to the full texts of standards in pdf (version for companies or individuals) may open directly quoted CSN here.