Medical devices. Guidance for their preparation in cleanrooms.

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

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!