EN 375:1992
(Main)In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for professional use
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- 28-May-1992
- 23-Jan-2001
- 11.100
- CEN/TC 140
In vitro diagnostic systems - Requirements for labelling in vitro diagnostic reagents for professional use
This standard specifies requirements for the labelling of in-vitro diagnostic reagents for professional use.
In-vitro-Diagnostik/Diagnostika - Kennzeichnung und Produktinformationen von In-vitro-Diagnostika für den Gebrauch durch Fachpersonal
Diese Norm führt Anforderungen an die Kennzeichnung und Produktinformationen von In-vitro-Diagnostica für den Gebrauch durch Fachpersonal auf.
Systèmes d'analyses médicales in vitro - Etiquetage des réactifs pour le diagnostic pour l'utilisation professionnelle
Cette norme précise les exigences applicables à l'étiquetage des réactifs pour le diagnostic in vitro à usage professionnel.
Diagnostični sistemi in vitro - Zahteve za označevanje diagnostičnih reagentov in vitro za profesionalno uporabo
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In-vitro-Diagnostik/Diagnostika - Kennzeichnung und Produktinformationen von In-vitro-Diagnostika für den Gebrauch durch FachpersonalSystemes d'analyses médicales in vitro - Etiquetage des réactifs pour le diagnostic pour l'utilisation professionnelleIn vitro diagnostic systems - Requirements for labelling in vitro diagnos
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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.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
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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The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
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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:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
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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.
The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
The following subjects are outside the scope of ISO 18153:2003: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.
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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.
This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.
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TC - Modifications in 2.6, 2.14, 4.5, Annex ZA and Bibliography
- Corrigendum3 pagesEnglish languagesale 10% offe-Library read for×1 day
- 17-Dec-2002
- 11.100
- 98/79/EC
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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.
The standard does not apply to the following:
- instruments and specimen receptacles;
NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards.
- general aspects of workers' protection;
- transportation of infectious goods;
- disposal measures.
NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.
- Standard8 pagesEnglish languagesale 10% offe-Library read for×1 day
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This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.
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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.
In particular, this standard applies to IVD MDs to
- 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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