FD S98-113

FD S98-113

December 1996
Published document Current

Medical devices. Guidance for their preparation in cleanrooms.

Le présent document est destiné à aider les fabricants de dispositifs médicaux (actifs ou non actifs, stériles ou non stériles) à concevoir et utiliser des salles propres pour la fabrication et le conditionnement de leurs dispositifs.Le présent document présente une analyse des parties traitant de salle propre des normes NF EN 46001, NF EN 46002, NF EN 724 et des Directives 90/385/CEE et 93/42/CEE.

See more
View the extract New: UPSELL service
Main informations

Collections

National standards and national normative documents

Publication date

December 1996

Number of pages

31 p.

Reference

FD S98-113

ICS Codes

11.040.01   Medical equipment in general
13.040.35   Cleanrooms and associated controlled environments

Classification index

S98-113

Print number

1 - 01/12/1996
Sumary
Medical devices. Guidance for their preparation in cleanrooms.

Le présent document est destiné à aider les fabricants de dispositifs médicaux (actifs ou non actifs, stériles ou non stériles) à concevoir et utiliser des salles propres pour la fabrication et le conditionnement de leurs dispositifs. Le présent document présente une analyse des parties traitant de salle propre des normes NF EN 46001, NF EN 46002, NF EN 724 et des Directives 90/385/CEE et 93/42/CEE.
Table of contents
  • Avant-propos
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    6
  • 4 La conception des salles propres
    6
  • 5 Analyse des référentiels applicables aux dispositifs médicaux
    9
  • 5.1 Analyse des normes NF EN 46001et NF EN 46002
    9
  • 5.2 Analyse de la norme NF EN 724
    13
  • 5.3 Analyse des Directives 90/385/CEE et 93/42/CEE (Exigences essentielles)
    20
  • 6 Autres référentiels
    20
  • Annexe A
    22
  • Annexe B
    23
  • Annexe C
    24
  • Annexe D
    25
  • Annexe E
    26
  • Annexe F
    27
  • Annexe G
    28
  • Annexe H
    29
  • Annexe I
    30
  • Annexe J
    31
  • Annexe K
    32
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!
New: UPSELL service
- The UPSELL service allows you to easily update one of your standards.
- With a single click, add a new language, the Requirements or Redline+ service and add one or more additional users.
- Whether you are in the process of acquiring a standard or it is already available in your personal space, the UPSELL service is available at every stage to help you understand it and implement it within your organization.
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