EN 46002:1996

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• Status: Withdrawn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
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/WG QS - CEN/CENELEC Coordinating working group on quality supplements
• Drafting Committee: CEN/CLC/WG QS - CEN/CENELEC Coordinating working group on quality supplements
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 09-Nov-2000
• Completion Date: 09-Nov-2000
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 46002:1999 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

Relations

• Replaces: EN 46002:1993/AC:1994 - Quality systems - Medical devices - Particular requirements for the application of EN 29002
• Effective Date: 22-Dec-2008