EN 724:1994

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices

This European Standard provides guidance on the establishment and maintenance of the quality systems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change, the requirements of those standards and is not intended to be used for the assessment of a manufacturer's quality system.  This European Standard provides examples of how to meet the requirements, recognising that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality systems for non-active medical devices.  Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness.  The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002.

Anleitung zur Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN 46002 für nicht-aktive Medizinprodukte

Diese europäische Norm ist eine Anleitung zur Einführung und Aufrechterhaltung der Qualitätssicherungssysteme nach EN 29001/EN 46001 oder EN 29002/EN 46002 bei der Herstellung nicht-aktiver Medizinprodukte. Sie enthält keine Erweiterungen oder sonstigen Veränderungen von Anforderungen dieser Normen und ist nicht zur Bewertung des Qualitätssicherungssystems eines Herstellers vorgesehen.

Guide d'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 pour les dispositifs médicaux non actifs

La présente norme européenne donne des conseils sur la façon d'établir et de maintenir les systèmes de qualité définis dans les EN 29001/EN 46001 ou les EN 29002/EN 46002 pour la fabrication des dispositifs médicaux non actifs. Elle n'ajoute rien aux prescriptions de ces normes, ni ne les modifie autrement, et elle n'est pas destinée à être utilisée pour l'évaluation d'un système qualité du fabricant.

Navodilo za uporabo EN 29001 in EN 46001 ter EN 29002 in EN 46002 za ne-aktivne medicinske pripomočke

General Information

• Status: Withdrawn
• Publication Date: 30-Oct-1994
• Withdrawal Date: 07-Jun-2005
• ICS: 11.020 - Medical sciences and health care facilities in general
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 5 - Good manufacturing practices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 08-Jun-2005
• Completion Date: 08-Jun-2005
• 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 724:2000 - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 724:2000
01-januar-2000
1DYRGLOR]DXSRUDER(1LQ(1WHU(1LQ(1]DQHDNWLYQH
PHGLFLQVNHSULSRPRþNH
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002
for non-active medical devices
Anleitung zur Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN
46002 für nicht-aktive Medizinprodukte
Guide d'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 pour les
dispositifs médicaux non actifs
Ta slovenski standard je istoveten z: EN 724:1994
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 724:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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