NF EN 60601-1-8/A1

Medical electrical equipment - Part 1-8 : general requirements for safety - Collateral standard : general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Le présent document modifie l'introduction, l'article 201, le tableau 208 et l'annexe AAA de la norme NF EN 60601-1-8. Ce document entre dans le champ d'application 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