EN ISO 10993-1:2009(zruš)

Biologické hodnocení zdravotnických prostředků - Část 1: Hodnocení a zkoušení v rámci procesu řízení rizika

Status:	Canceled EN ISO 10993-1:2009(zruš) is replaced EN ISO 10993-1:2009
Poznámka:

Full text EAD:
Sector of EN ISO 10993-1:2009(zruš):	AIMD \| Active implantable medical devices MDD \| Medical devices
Sphere of EN ISO 10993-1:2009(zruš):	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
Notified bodies (NANDO):	Notified bodies for Council directive 90/385/EEC Notified bodies for Council Directive 93/42/EEC

ES/EU regulation	ČR regulation	SR regulation
	nařízení vlády č. 55/2015 Sb. repealed by 89/2021 Coll. from 26th May 2021
		Government Regulation SR No 167/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.
Council directive 90/385/EEC /repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Commission implementing decision No (EU)2019/1396 / Commission decision No 2010/227/EU / Regulation Commission No 207/2012 will be repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024) / Regulation Commission No 722/2012
Council Directive 93/42/EEC / repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable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 repealed by 89/2021 Coll.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		Government Regulation SR No 166/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.