XP S99-171

XP S99-171

December 2001
Standard Cancelled

Maintenance of medical devices - Model and definition for establishment and management of the medical security, quality and maintenance register (RSQM)

Le présent document fixe les exigences et des recommandations pour mettre en place et tenir à jour un Registre de Sécurité, de Qualité et de Maintenance d'un dispositif médical.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

December 2001

Number of pages

25 p.

Reference

XP S99-171

ICS Codes

11.040.01   Medical equipment in general

Classification index

S99-171

Print number

1 - 09/01/2002
Sumary
Maintenance of medical devices - Model and definition for establishment and management of the medical security, quality and maintenance register (RSQM)

Le présent document fixe les exigences et des recommandations pour mettre en place et tenir à jour un Registre de Sécurité, de Qualité et de Maintenance d'un dispositif médical.
Standard replaced by (1)
NF S99-171
July 2006
Standard Current
Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM)

Le présent document fixe les exigences et les recommandations pour mettre en place et tenir à jour un Registre de Sécurité, de Qualité et de Maintenance d'un dispositif médical.

Table of contents
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    5
  • 3 Termes et définitions
    5
  • 4 Exigence pour la construction du registre RSQM des dispositifs médicaux
    7
  • 4.1 Généralité
    7
  • 4.2 Description du RSQM
    7
  • 4.3 Description des fiches du RMQS
    11
  • Annexe A (informative) Page de garde d'un registre sécurité, qualité et maintenance d'un dispositif médical
    20
  • Annexe B (informative) Exemple issue d'une GMAO informatique Fiche F1
    23
ZOOM ON ... the Requirements department
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!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

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