NF EN 60601-1/A11

Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance

Le présent document modifie l'Annexe ZZ de la norme homologuée NF EN 60601-1 de janvier 2007. Le présent document entre dans le champ d'application de la Directive n°90/385/CEE du 20/06/1990, concernant le rapprochement des législations des États membres relatives aux dispositifs médicaux implantables actifs et de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ