NF EN ISO 13485
NF EN ISO 13485

NF EN ISO 13485

January 2004
Standard Cancelled

Medical devices — Quality management systems — Requirements for regulatory purposes

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Main informations

Collections

National standards and national normative documents

Thematics

Management et performance

Publication date

January 2004

Number of pages

74 p.

Reference

NF EN ISO 13485

ICS Codes

03.100.70   Management systems
03.120.10   Quality management and quality assurance
11.040.01   Medical equipment in general

Print number

2 - septembre 2007

International kinship

ISO 13485:2003

European kinship

EN ISO 13485:2003
Replaced standards (3)
NF EN ISO 13488
NF EN ISO 13488
February 2001
Standard Cancelled
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

NF EN ISO 13485
NF EN ISO 13485
February 2001
Standard Cancelled
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

NF EN 46003
NF EN 46003
October 1999
Standard Cancelled
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

Le présent document, conjointement avec la NF EN ISO 9003, spécifie les exigences relatives aux systèmes qualité en matière de contrôle et essais finals des dispositifs médicaux dans le domaine d''application de la NF EN ISO 9003. Il est applicable, conjointement avec la NF EN ISO 9003, lorsque le système qualité d''un fournisseur de dispositifs médicaux est évalué conformément aux exigences régle-mentaires.

Standard replaced by (1)
NF EN ISO 13485
NF EN ISO 13485
September 2012
Standard Cancelled
Medical devices - Quality management systems - Requirements for regulatory purposes

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