Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

This European Standard specifies, in conjunction with EN ISO 9002, the quality system requirements for the production, and where relevant, installation of medical devices.  The field of application of EN ISO 9002 applies. In addition, this European Standard, in conjunction with EN ISO 9002, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.  As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.

Qualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die Anwendung von EN ISO 9002

Systemes qualité - Dispositifs médicaux - Exigences particulieres relatives a l'application de l'EN ISO 9002

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

General Information

Status
Withdrawn
Publication Date
31-Oct-1999
Withdrawal Date
24-Aug-2009
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
20-Aug-2009
Due Date
12-Sep-2009
Completion Date
25-Aug-2009

RELATIONS

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SIST EN 46002:1999
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