NBN EN ISO 14971:2020

NBN EN ISO 14971:2020

Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte (ISO 14971:2019)

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Directives : Active implantable medical devices,Medical devices,In vitro diagnostic medical devices,Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market,Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC,Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Zusätzliche Information

Autor Bureau de Normalisation Belge (NBN)
Veröffentlicht von NBN
Document type Normen
ICS 11.040.01 : Medizinische Geräte allgemein
Ersetzt NBN EN ISO 14971:2012
angepasst von NBN EN ISO 14971:2019/A11:2021
Historische Dokumente No
Schlagwort EN ISO 14971, EN ISO 14971:2020
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