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EN 60601-2-54:2009

Medical electrical equipment -- Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures

Status: Harmonized EN 60601-2-54:2009 replaces   EN 60601-2-28:1993 (Canceled) EN 60601-2-32:1994 (Canceled) EN 60601-2-7:1998 (Canceled)
Poznámka:
Full text EAD:
Sector of EN 60601-2-54:2009: MDD | Medical devices (placed on the market to 26. 5. 2021)
Sphere of EN 60601-2-54:2009: 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/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197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 decision No (EU)2019/1396
/ Commission Desicion No (EU)2018/1617
/ 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 repealed by 89/2021 Coll.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// 25. 5. 2021 repealed by No 362/2011 Coll.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: 01.08.2012 (MDD)
Released: January, 2011

Note

Tato evropská norma nemusí nutně zahrnovat požadavky zavedené směrnicí 2007/47/ES.

ČSN

ČSN EN 60601-2-54:2010   Note to ČSN EN 60601-2-54:2010: připravuje se vydání změny A2:2019 - úkol č. 36/0050/19, ukončení 19-09 (Věstník č. 8/2019)
Změna A1-12.15  
Změna A2-10.19  

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