EN 46003:1999

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

This European Standard specifies, in conjunction with EN ISO 9003 : 1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.  NOTE: For sterile medical devices the relevant particular clauses inEN 46002 : 1996 apply as this standard alone is not sufficient for manufacturers of sterile medical devices seeking to comply 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 9003

Diese Europäische Norm legt zusammen mit EN ISO 9003:1994 Anforderungen an das Qualitätssicherungssystem für die Endprüfung von Medizinprodukten fest. Ausgenommen sind In-vitro-Diagnostika und aktive implantierbare Medizinprodukte. Sie ist anwendbar, wenn das Qualitätssicherungssystem eines Lieferanten für Medizinprodukte in Übereinstimmung mit gesetzlichen Anforderungen beurteilt wird.

Système de qualité - Dispositifs médicaux - Exigences particulières relatives à l'application de l'EN ISO 9003

Cette norme européenne, conjointement avec l'EN ISO 9003:1994, spécifie des exigences relatives aux systèmes qualité en matière de contrôle et essais finals des dispositifs médicaux, à l'exclusion des dispositifs médicaux pour le diagnostic in-vitro et des dispositifs médicaux implantables actifs, et est applicable lorsque le système qualité d'un fournisseur de dispositifs médicaux est évalué conformément aux exigences réglementaires.

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

General Information

• Status: Withdrawn
• Publication Date: 17-Aug-1999
• Withdrawal Date: 26-Jun-2007
• 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: 27-Jun-2007
• Completion Date: 27-Jun-2007
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 46003:2002 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003

Relations

• Replaced By: EN ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 46003:2002
01-februar-2002
Quality systems - Medical devices - Particular requirements for the application of
EN ISO 9003
Quality systems - Medical devices - Particular requirements for the application of EN ISO
9003
Qualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die
Anwendung von EN ISo 9003
Systeme de qualité - Dispositifs médicaux - Exigences particulieres relatives a
...