EN ISO 17511:2021
(Main)In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
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.
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
In-vitro-Diagnostika - Anforderungen an die Ermittlung metrologischer Rückführbarkeit von Werten, die Kalibratoren, Richtigkeitskontrollmaterialien und Humanproben zugeordnet sind (ISO 17511:2020)
Dieses Dokument spezifiziert die technischen Anforderungen und die erforderliche Dokumentation, um die metrologische Rückführbarkeit von Werten zu etablieren, die Kalibratoren, Richtigkeitskontrollmaterialien und Humanproben hinsichtlich der mithilfe von In vitro-Diagnostika gemessenen Größen zugeordnet wurden. Die Humanproben sind dabei die zu messenden Proben, so wie dies für das jeweilige In vitro-Diagnostikum festgelegt ist. Die metrologische Rückführbarkeit von Werten für Messgrößen in Humanproben erstreckt sich bis auf die verfügbare Referenzsystemkomponente der höchstmöglichen Ordnung, idealerweise auf Referenzmessverfahren und zertifizierte Referenzmaterialien (ZRMs).
Alle Parteien, die eine Funktion in einer beschriebenen Kalibrierhierarchie für ein In vitro-Diagnostikum übernehmen, unterliegen den beschriebenen Anforderungen. Zu diesen Parteien gehören, ohne darauf beschränkt zu sein: Hersteller (von In vitro-Diagnostika), Entwickler von Referenzmessverfahren (siehe ISO 15193), Hersteller von Referenzmaterialien (siehe ISO 15194) und Referenz /Kalibrierlaboratorien (siehe ISO 15195), die Kalibrierhierarchien für In vitro-Diagnostika abstützen bzw. nutzen.
[...]
Dispositifs médicaux de diagnostic in vitro - Exigences pour l'établissement d'une traçabilité métrologique des valeurs attribuées aux étalons, aux matériaux de contrôle de la justesse et aux échantillons humains (ISO 17511:2020)
Le présent document spécifie les exigences techniques et la documentation nécessaire pour établir la traçabilité métrologique des valeurs assignées aux étalons, aux matériaux de contrôle de la justesse et aux échantillons humains pour des grandeurs mesurées par des dispositifs médicaux de DIV. Les échantillons humains sont les échantillons destinés à être mesurés, tel que spécifié pour chaque dispositif médical de DIV. La traçabilité métrologique des valeurs pour les grandeurs dans des échantillons humains s'étend jusqu'au composant du système de référence le plus élevé disponible, dans l'idéal jusqu'aux PMR et aux matériaux de référence certifiés (MRC).
Toutes les parties impliquées dans l'une des étapes décrites dans une hiérarchie d'étalonnage pour un dispositif médical de DIV sont soumises aux exigences décrites. Ces parties comprennent, de manière non exhaustive, les fabricants (des dispositifs médicaux de DIV), les concepteurs des PMR (voir l'ISO 15193), les fabricants de MR (voir l'ISO 15194) et les laboratoires d'étalonnage/de référence (voir l'ISO 15195) qui mettent en place des hiérarchies d'étalonnage pour les dispositifs médicaux de DIV.
NOTE 1 Parmi les fabricants de MR destinés à être utilisés dans le cadre de la normalisation ou de l'étalonnage de dispositifs médicaux de DIV figurent des organisations commerciales et non commerciales qui produisent des MR à l'attention de nombreux utilisateurs finaux de dispositifs médicaux de DIV et/ou de laboratoires d'étalonnage ou d'un seul laboratoire de biologie médicale, comme dans le cas d'un étalon destiné à être utilisé exclusivement à des fins d'étalonnage d'une PM développée par un laboratoire.
Le présent document s'applique à:
a) tous les dispositifs médicaux de DIV qui fournissent des résultats de mesure sous forme de valeurs numériques, c'est-à-dire des échelles rationnelles (rapport) et/ou différentielles (intervalle) et des échelles de dénombrement;
b) les dispositifs médicaux de DIV dont le résultat de mesure est présenté sous forme de valeur qualitative établie à l'aide d'un rapport entre deux mesurages (c'est-à-dire le signal d'un échantillon soumis à essai et le signal d'un MR présentant une concentration spécifiée ou une activité à la valeur seuil) ou d'une échelle de dénombrement avec des seuils de décision correspondants. Cela comprend également les dispositifs médicaux de DIV dont les résultats sont classés par catégories ordinales à partir d'intervalles quantitatifs préétablis pour une grandeur;
c) des MR destinés à être utilisés comme matériaux de contrôle de la justesse pour la vérification ou l'évaluation de l'étalonnage de dispositif médical de DIV, c'est-à-dire certains MRC commutables et certains matériaux d'évaluation externe de la qualité (EEQ) (si indiqué dans la déclaration d'usage prévu du MR);
d) des étalons et des matériaux de contrôle de la justesse spécifiques aux dispositifs médicaux de DIV dont les valeurs sont assignées, destinés à être utilisés conjointement avec un dispositif médical de DIV spécifié;
e) les dispositifs médicaux de DIV, tels que décrits en a) et b), qui ne requièrent pas la réalisation d'un étalonnage par l'utilisateur final (c'est-à-dire lorsque le fabricant procède à un étalonnage d'un dispositif médical de DIV en usine).
Le présent document ne s'applique pas:
a) aux étalons et aux matériaux de contrôle de la justesse pour les dispositifs médicaux de DIV dont il est établi, en raison de leur formulation,
In vitro diagnostični medicinski pripomočki - Zahteve za vzpostavitev meroslovne sledljivosti vrednosti, dodeljenih kalibratorjem, kontrolnim materialom in vzorcem človeškega izvora (ISO 17511:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 17511:2003
In vitro diagnostični medicinski pripomočki - Zahteve za vzpostavitev meroslovne
sledljivosti vrednosti, dodeljenih kalibratorjem, kontrolnim materialom in vzorcem
človeškega izvora (ISO 17511:2020)
In vitro diagnostic medical devices - Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and human
samples (ISO 17511:2020)
In-vitro-Diagnostika - Anforderungen an die Ermittlung metrologischer Rückführbarkeit
von Werten, die Kalibratoren, Richtigkeitskontrollmaterialien und Humanproben
zugeordnet sind (ISO 17511:2020)
Dispositifs médicaux de diagnostic in vitro - Exigences pour l'établissement d'une
traçabilité métrologique des valeurs attribuées aux étalons, aux matériaux de contrôle de
la justesse et aux échantillons humains (ISO 17511:2020)
Ta slovenski standard je istoveten z: EN ISO 17511:2021
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
17.020 Meroslovje in merjenje na Metrology and measurement
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17511
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.100.10 Supersedes EN ISO 17511:2003
English Version
In vitro diagnostic medical devices - Requirements for
establishing metrological traceability of values assigned to
calibrators, trueness control materials and human samples
(ISO 17511:2020)
Dispositifs médicaux de diagnostic in vitro - Exigences In-vitro-Diagnostika - Anforderungen an die
pour l'établissement d'une traçabilité métrologique Ermittlung metrologischer Rückführbarkeit von
des valeurs attribuées aux étalons, aux matériaux de Werten, die Kalibratoren,
contrôle de la justesse et aux échantillons humains Richtigkeitskontrollmaterialien und Humanproben
(ISO 17511:2020) zugeordnet sind (ISO 17511:2020)
This European Standard was approved by CEN on 4 February 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17511:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 5
European foreword
This document (EN ISO 17511:2021) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2021, and conflicting national standards
shall be withdrawn at the latest by June 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17511:2003.
This document has been prepared under a standardization request/mandate given to CEN by the
European Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
NOTE In this European Standard the concept "accuracy of measurement" is not equivalent to "trueness of
measurement" (see 3.47) nor to the "precision of measurement" (see 3.34) alone. Instead, accuracy is commonly
used as a combination of trueness and precision, which is also used as a concept in the Regulation 2017/746/EU
on in-vitro diagnostic medical devices.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 18113-2:2009 EN ISO 18113-2:2011 ISO 18113-2:2009
ISO 15193 EN ISO 15193:2009 ISO 15193:2009
ISO 15194 EN ISO 15194:2009 ISO 15194:2009
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 17511:2020 has been approved by CEN as EN ISO 17511:2021 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/746 of 5 April 2017 concerning in vitro diagnostic medical devices [OJ L 117].
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/746 [OJ L 117]
General Safety and Clause(s)/sub-clause(s) of Remarks/Notes
Performance Requirements this EN
of Regulation (EU) 2017/746
9.1 (a) 4.3, 4.6.2 Covered with respect to analytical
performance requirements resul-
ting from a calibration hierarchy,
and related uncertainty
9.3 4.1, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5 Covered
10.1 4.2, 4.5.4, 4.5.5 Covered with respect to definition
of the measurand, corresponding
performance characteristics and
commutability during design and
manufacturing processes
13.4 4.7, 4.8 Covered with respect to
effectiveness and reliability of
calibration
13.5 4.5.4, 4.5.5, 4.8 Covered with respect to
commutability and traceability of
end-user calibrator
14.1 4.3, 4.6.2 Covered with respect to analytical
performance requirements resul-
ting from a calibration hierarchy,
and related uncertainty
20.1 (g) 4.3, 4.7.1 Covered with respect to uncer-
tainty as a limitation and
information to be provided by the
manufacturer
20.4.1 (g) 4.7.1 Covered with respect to uncer-
tainty of assigned values for end-
user calibrator and information to
be provided by the manufacturer
20.4.1 (u) 4.7.1, 4.9.1, 4.9.3 Partly covered with respect to
uncertainty and assigned values of
end-user calibrators and their
associated metrological traceability
as the kind of information to be
provided by the manufacturer, but
the requirement to provide this
information in the IFU is not
addressed by this European
standard.
20.4.1 (w) 4.6.2, 4.7.1, 4.9.1 Partly covered with respect to
analytical performance require-
ments resulting from a calibration
hierarchy, assigned values for end-
user calibrators and their
associated metrological traceability
as the kind of information to be
provided by the manufacturer, but
the requirement to provide this
information in the IFU is not
addressed by this European
standard.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 17511
Second edition
2020-04
In vitro diagnostic medical devices —
Requirements for establishing
metrological traceability of values
assigned to calibrators, trueness
control materials and human samples
Dispositifs médicaux de diagnostic in vitro — Exigences pour
l'établissement d'une traçabilité métrologique des valeurs attribuées
aux étalons, aux matériaux de contrôle de la justesse et aux
échantillons humains
Reference number
ISO 17511:2020(E)
©
ISO 2020
ISO 17511:2020(E)
© ISO 2020
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ii © ISO 2020 – All rights reserved
ISO 17511:2020(E)
Contents Page
Foreword .vi
Introduction .viii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions, symbols and abbreviated terms .
...
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