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CEN

EN 591:1994

(Main)

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

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

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

In-vitro Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-Diagnostika-Geräte zum Gebrauch durch Fachpersonal

Diese Norm legt den Inhalt von Benutzerhandbüchern für In-vitro-Diagnostica- Geräte zum Gebrauch durch Fachpersonal 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 professionnel

Cette norme spécifie le contenu des manuels d'utilisation pour les instruments de diagnostic in vitro pour usage professionnel.  Les manuels d'utilisation sont essentiels pour permettre un usage correct et sans danger des instruments. Cette norme ne s'applique pas aux instructions de réparation.

Diagnostični sistemi in vitro - Zahteve za priročnike za uporabnike diagnostičnih instrumentov in vitro za profesionalno uporabo

General Information

Status
Withdrawn
Publication Date
08-Sep-1994
Withdrawal Date
20-Mar-2001
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
21-Mar-2001
Completion Date
21-Mar-2001
Ref Project
SIST EN 591:2000 - In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use

Relations

Replaced By
EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 591:2000
01-januar-2000
'LDJQRVWLþQLVLVWHPLLQYLWUR=DKWHYH]DSULURþQLNH]DXSRUDEQLNHGLDJQRVWLþQLK
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In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic
instruments for professional use
In-vitro Diagnostik/Diagnostika - Anforderungen an Benutzerhandbücher für In-vitro-
Diagnostika-Geräte zum Gebrauch durch Fachpersonal
Systemes d'analyses médicales in vitro - Regles pour les manuels d'utilisation
d'instruments pour le diagnostic in vitro pour usage professionnel
Ta slovenski standard je istoveten z: EN 591:1994
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN 591:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
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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).
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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b)   IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
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.
e)   IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a)   calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b)   control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
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.
NOTE 3

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This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
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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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- classification and evaluation of data.
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ISO 18153:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.
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This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body.
Two different provisions are addressed:
a) verification by testing attributes and/or variables on a statistical basis;
b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control.
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This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.
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This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE   For a selection of publications on specific evaluation plans see Bibliography.
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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- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.

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