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

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