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.

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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
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