EN 45502-1:1997

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

Status:	Harmonized
Poznámka:

Full text EAD:
Sector of EN 45502-1:1997:	AIMD \| Active implantable medical devices (placed on the market to 26. 5. 2021)
Sphere of EN 45502-1:1997:	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
Notified bodies (NANDO):	Notified bodies for Council directive 90/385/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 repealed by 89/2021 Coll.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		Government Regulation SR No 167/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.
Council directive 90/385/EEC /repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable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implementing decision No (EU)2019/1396 / Commission decision No 2010/227/EU / Regulation Commission No 207/2012 repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024) / Regulation Commission No 722/2012

Released:

August, 1998

Note

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

ČSN

ČSN EN 45502-1:1998			Note to ČSN EN 45502-1:1998: Nahrazena od 20.04.2018 ČSN EN 45502-1 ed. 2 (853000) z února 2016
Změna Z1-2.16

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