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CEN

EN 1658:1996

(Main)

Requirements for marking of in vitro diagnostic instruments

Requirements for marking of in vitro diagnostic instruments

This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1 : 1993.  An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.

Anforderungen an die Kennzeichnung von In-vitro-Diagnostika-Geräten

Diese Norm legt Anforderungen an die Kennzeichnung von In-vitro-Diagnostika- Geräten fest. Bei Anwendung auf elektrische Laborgeräte gelten die Anforderungen zusätzlich zu den in den Abschnitten 5.1 bis 5.3 von EN 61 010-1:1993 festgelegten Anforderungen. Leicht verständliche und einheitliche Kennzeichnung ist wichtig für die sichere und richtige Handhabung von In-vitro-Diagnostika-Geräten.

Exigences de marquage des instruments de diagnostic in vitro

Cette norme définit des exigences relatives au marquage des instruments de diagnostic in vitro. En liaison avec l'équipement électrique utilisé en laboratoire, les exigences sont complémentaires à celles spécifiées dans les articles 5.1 à 5.3 de l'EN 61 010-1:1993. Un marquage uniforme facilement compréhensible des instruments de diagnostic in vitro est important pour leur utilisation correcte et sûre.

Zahteve za označevanje diagnostičnih instrumentov in vitro

General Information

Status
Withdrawn
Publication Date
10-Dec-1996
Withdrawal Date
13-May-2004
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
14-May-2004
Completion Date
14-May-2004
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/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
Ref Project
SIST EN 1658:2000 - Requirements for marking of in vitro diagnostic instruments

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anforderungen an die Kennzeichnung von In-vitro-Diagnostika-GerätenExigences de marquage des instruments de diagnostic in vitroRequirements for marking of in vitro diagnostic instrume
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All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1      Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
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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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c)   control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
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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Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
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