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SIST

SIST EN 928:2000

(Main)

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

This European Standard provides guidance on the implementation of EN 29001 and EN 46001 and of EN 29002 and EN 46002 as applied to the manufacturer of IVDs. It is aimed at affording a better understanding of the standards themselves as well as assistance in its use, either implementing or evaluating such a quality system. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be drawn.  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 particular requirements in EN 46001 and EN 46002.

In-vitro-Diagnostik/Diagnostika - Leitfaden für die Anwendung von EN 29001 und EN 46001 sowie EN 29002 und EN 46002 für Medizinprodukte für die In-vitro-Diagnose

Diese europäische Norm ist ein Leitfaden für die Anwendung der Normen EN 29001und EN 46001 sowie EN 29002 und EN 46002 bei der Herstellung von Medizinprodukten für die In-vitro Diagnose. Er soll dazu beitragen, diese Normen besser zu verstehen und ihre Anwendung sowohl bei der Einrichtung als auch bei der Bewertung eines Qualitätssicherungssystems zu erleichtern. Es ist nicht beabsichtigt, in dem vorliegenden Leitfaden alle Aspekte erschöpfend zu behandeln, vielmehr soll die Aufmerksamkeit auf Schwerpunkte gelenkt werden.

Systemes d'analyses médicales in vitro - Guide d'application des EN 29001 et EN 46001, et EN 29002 et EN 46002 pour les dispositifs médicaux de diagnostic in vitro

Cette norme européenne donne des conseils pour l'application des normes EN 29001et EN 46001, et EN 29002 et EN 46002 dans la fabrication des DIV. Elle a pour but de permettre une meilleure compréhension de la norme elle-meme, aussi bien que d'aider dans son utilisation, que ce soit en réalisant ou en évaluant un telsysteme. Les conseils fournis ne sont pas exhaustifs mais mettent en lumiere lesaspects importants sur lesquels l'attention devrait etre attirée.

Diagnostični sistemi in vitro - Navodila za uporabo EN 29001 in EN 46001 ter EN 29002 in EN 46002 za diagnostične medicinske pripomočke

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
Withdrawal Date
28-Feb-2005
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Mar-2005
Due Date
01-Mar-2005
Completion Date
01-Mar-2005
Directive
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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
EN 928:1995 - In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 928:2000
01-januar-2000
'LDJQRVWLþQLVLVWHPLLQYLWUR1DYRGLOD]DXSRUDER(1LQ(1WHU(1
LQ(1]DGLDJQRVWLþQHPHGLFLQVNHSULSRPRþNH
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001
and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
In-vitro-Diagnostik/Diagnostika - Leitfaden für die Anwendung von EN 29001 und EN
46001 sowie EN 29002 und EN 46002 für Medizinprodukte für die In-vitro-Diagnose
Systemes d'analyses médicales in vitro - Guide d'application des EN 29001 et EN
46001, et EN 29002 et EN 46002 pour les dispositifs médicaux de diagnostic in vitro
Ta slovenski standard je istoveten z: EN 928:1995
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 928:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 928:2000

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SIST EN 928:2000

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