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CEN

EN 592:1994

(Main)

In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home use

In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home use

This standard specifies the content of user manuals for in-vitro diagnostic instruments for home use. User manuals are essential to enable the safe and proper operation of instruments by trained and untrained personnel. This standard is not applicable to  field repair instructions.

In-vitro-Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-Diagnostika-Geräte zum Gebrauch zu Hause

Diese Norm legt den Inhalt von Benutzerhandbücher von In-vitro-Diagnostica- Geräte zum Gebrauch zu Hause fest. Benutzerhandbücher sind erforderlich, um den sicheren und fachgerechten Betrieb von Geräten zu ermöglichen. Diese Norm ist nicht anwendbar auf Anweisungen für die Durchführung von Reparaturen.

Systèmes d'analyses médicales in vitro - Règles pour les manuels d'utilisation d'instruments pour le diagnostic in vitro pour usage à domicile

Cette norme spécifie le contenu des manuels d'utilisation pour les instruments de diagnostic in vitro pour usage à domicile.  Les manuels d'utilisation sont essentiels pour permettre un usage correct et sans danger des instruments par du pesonnel formé ou non.  Cette norme n'est pas applicable aux instructions de réparation.

Diagnostični sistemi in vitro - Zahteve za priročnike za uporabnike diagnostičnih instrumentov in vitro na domu

General Information

Status
Withdrawn
Publication Date
08-Sep-1994
Withdrawal Date
12-Feb-2002
ICS
11.100 - Laboratory medicine
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 1 - Labelling and performance evaluation
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
13-Feb-2002
Completion Date
13-Feb-2002
Ref Project
SIST EN 592:2000 - In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home use

Relations

Replaced By
EN 592:2002 - Instructions for use for in vitro diagnostic instruments for self-testing
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 592:2000
01-januar-2000
'LDJQRVWLþQLVLVWHPLLQYLWUR=DKWHYH]DSULURþQLNH]DXSRUDEQLNHGLDJQRVWLþQLK
LQVWUXPHQWRYLQYLWURQDGRPX
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic
instruments for home use
In-vitro-Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-
Diagnostika-Geräte zum Gebrauch zu Hause
Systemes d'analyses médicales in vitro - Regles pour les manuels d'utilisation
d'instruments pour le diagnostic in vitro pour usage a domicile
Ta slovenski standard je istoveten z: EN 592:1994
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 592:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
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c)   RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d)   IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
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d)   properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2  Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
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This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
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