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

Systèmes qualité - Dispositifs médicaux - Exigences particulières relatives à 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Withdrawn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-Jul-1996
Withdrawal Date
08-Nov-2000
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
09-Nov-2000
Completion Date
09-Nov-2000

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EN 46002:1999
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