SIST 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 laboratorydeveloped
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 Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g. ‘sick’
vs. ‘healthy’), and occasionally to results differentiated into non-dichotomous categories where the result
categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative
degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual
observation.
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
SIST EN ISO 17511:2021
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
SIST EN ISO 17511:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 17511:2021
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SIST EN ISO 17511:2021
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.
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SIST EN ISO 17511:2021
EN ISO 17511:2021 (E)
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
2
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SIST EN ISO 17511:2021
EN ISO 17511:2021 (E)
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
3
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SIST EN ISO 17511:2021
EN ISO 17511:2021 (E)
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.
4
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SIST EN ISO 17511:2021
EN ISO 17511:2021 (E)
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
5
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SIST EN ISO 17511:2021
EN ISO 17511:2021 (E)
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.
6
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SIST EN ISO 17511:2021
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
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SIST EN ISO 17511:2021
ISO 17511:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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below or ISO’s member body in the country of the requester.
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Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 17511:2021
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 . 2
4 General requirements to be fulfilled by a manufacturer for establishing, validating
and documenting metrological traceability of human sample values determined
with a specified IVD MD .19
4.1 Requirements for documenting metrological traceability of measured quantity values .19
4.2 Definition of the measurand .19
4.3 Specifications for maximum allowable expanded measurement uncertainty, Umax(y) .20
4.3.1 General requirements .20
4.3.2 Scope of the specification .20
4.4 Defining the calibration hierarchy .20
4.4.1 General requirements .20
4.4.2 Measured quantity .21
4.4.3 Highest level of metrological traceability .21
4.4.4 Traceability to SI .21
4.4.5 Non-SI traceable IVD MDs .21
4.4.6 Number of levels in the specified hierarchy .21
4.5 Selection and requirements for RMs and calibrators .21
4.5.1 General requirements .21
4.5.2 Characteristics to be documented .21
4.5.3 Higher order RMs that conform with ISO 15194 .22
4.5.4 RMs not conforming to ISO 15194 .22
4.5.5 Commutability of RMs . .22
4.5.6 Exception to commutability assessment requirements .23
4.5.7 Application of a non-commutable CRM .23
4.5.8 Alternative RMs.23
4.5.9 Augmentation of alternative RMs .23
4.5.10 Non-commutable end-user IVD MD calibrators .24
4.6 Selection and requirements for MPs .24
4.6.1 Rationale for selection of MPs and documentation responsibility .24
4.6.2 Metrological status of MPs .24
4.6.3 Reference measurement laboratories .24
4.6.4 Impact of influence quantities .25
4.6.5 Changes in the measured quantity within a calibration hierarchy .25
4.7 Estimating uncertainty of assigned values for end-user IVD MD calibrators .25
4.7.1 General requirements .25
4.7.2 Documentation for method of estimating u .26
cal
4.7.3 Statistical considerations and scope of u estimates .26
cal
4.7.4 Expression of u . . .26
cal
4.7.5 Product modifications .27
4.7.6 Information to be provided to the end-user .28
4.8 Validation of metrological traceability of values assigned to an IVD MD calibrator .28
4.8.1 General validation requirements .28
4.8.2 Validation strategies .28
4.8.3 Test design considerations and acceptance criteria .29
4.8.4 Calibration hierarchies with an available RMP.29
4.8.5 Calibration hierarchies with no available RMP .29
4.8.6 Calibration hierarchies with no RMPs and no CRMs .29
4.8.7 Validation of design changes to an end-user IVD MD calibrator .30
4.9 Additional calibration hierarchy documentation responsibilities .30
© ISO 2020 – All rights reserved iii
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SIST EN ISO 17511:2021
ISO 17511:2020(E)
4.9.1 Obligation to end-users .30
4.9.2 Maintaining documentation .30
4.9.3 Third party manufacturers of IVD MD calibrators .30
4.9.4 Modifications introduced by independent entities .30
4.9.5 Calibration hierarchies supporting IVD MDs developed by a single entity
for its own use .31
4.9.6 RMs other than end-user IVD MD calibrators .31
4.9.7 EQA and PT materials with claims of metrologically traceable target values .31
5 Model calibration hierarchies for metrological traceability .31
5.1 Elements of the description of a calibration hierarchy .31
5.2 Cases with RMPs and primary RMs .32
5.2.1 General considerations .32
5.2.2 Definition of the measurand .33
5.2.3 Selecting RMPs .34
5.2.4 Primary RMPs . .34
5.2.5 Primary calibrators.35
5.2.6 Assigning a value to a secondary RM or calibrator .35
5.2.7 Commutability of secondary RMs .35
5.2.8 Manufacturer’s Selected MP.35
5.2.9 Working calibrators . .35
5.2.10 Manufacturer’s standing MP .36
5.2.11 Manufacturer's end-user calibrator .36
5.2.12 u of the assigned value of the end-user calibrator .36
cal
5.2.13 End-user IVD MD .36
5.3 Cases with a primary RMP that defines the measurand .36
5.3.1 General Considerations .36
5.3.2 Definition of the measurand .38
5.3.3 Higher order RMP that defines the measurand .38
5.3.4 The primary RMP and definition of the measurand .38
5.3.5 Documentation of the primary RMP .38
5.3.6 Assignment of values to secondary RMs .39
5.3.7 Manufacturer’s selected MP .39
5.3.8 Manufacturer's working calibrator .39
5.3.9 Manufacturer’s standing MP .40
5.3.10 Manufacturer's end-user calibrator .40
5.3.11 End-user IVD MD .40
5.4 Cases for measurands defined by a RMP calibrated with a particular primary calibrator 40
5.4.1 General considerations .40
5.4.2 Definition of the measurand .41
5.4.3 Value assignment of the primary RM .42
5.4.4 Value assignment of the primary calibrator .42
5.4.5 Selection and intended use of the RMP in the calibration hierarchy .42
5.4.6 Manufacturer's selected MP .42
5.4.7 Manufacturer’s working calibrator .42
5.4.8 Manufacturer’s standing MP .43
5.4.9 End-user IVD MD calibrator .43
5.4.10 End-user IVD MD .43
5.5 Cases with an international conventional calibrator that defines the measurand .43
5.5.1 General considerations .43
5.5.2 The international conventional calibrator — Material description .45
5.5.3 Value assignment of an international conventional calibrator .45
5.5.4 Commutability of an international conve
...
SLOVENSKI STANDARD
oSIST prEN ISO 17511:2019
01-maj-2019
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VOHGOMLYRVWLYUHGQRVWLGRGHOMHQLKNDOLEUDWRUMHPNRQWUROQLPPDWHULDORPLQ
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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/DIS 17511:2019)
In-vitro-Diagnostika - Messung von Grössen in Proben biologischen Ursprungs -
Metrologische Rückverfolgbarkeit von Werten, die Kalibratoren und Kontrollmaterialien
zugeordnet sind (ISO/DIS 17511:2019)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des
échantillons d'origine biologique - Traçabilité métrologique des valeurs attribuées aux
agents d'étalonnage et aux matériaux de contrôle (ISO/DIS 17511:2019)
Ta slovenski standard je istoveten z: prEN ISO 17511
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
oSIST prEN ISO 17511:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 17511:2019
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oSIST prEN ISO 17511:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17511
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-03-14 2019-06-06
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 — Mesurage des grandeurs dans des échantillons d'origine
biologique — Traçabilité métrologique des valeurs attribuées aux agents d'étalonnage et aux matériaux de
contrôle
ICS: 11.100.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 17511:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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oSIST prEN ISO 17511:2019
ISO/DIS 17511:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 17511:2019
ISO/DIS 17511:2019(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements to be fulfilled by a manufacturer for establishing, validating
and documenting metrological traceability of human sample values determined
with a specified IVD MD .19
4.1 Requirements for documenting metrological traceability of measured quantity values .19
4.2 Definition of the measurand .20
4.3 Specifications for maximum allowable expanded measurement uncertainty, Umax(y) .20
4.4 Defining the calibration hierarchy – general requirements .21
4.5 Selection and requirements for RMs and calibrators .21
4.6 Selection and requirements for MPs .24
4.7 Estimating uncertainty of assigned values for end-user IVD MD calibrators .25
4.8 Validation of metrological traceability of values assigned to an IVD MD calibrator .26
4.9 Additional manufacturer documentation responsibilities .29
5 Model calibration hierarchies for metrological traceability .30
5.1 Elements of the description of a calibration hierarchy .30
5.2 Cases with RMPs and primary RMs .30
5.3 Cases with a primary RMP that defines the measurand .34
5.4 Cases for measurands defined by a RMP calibrated with a particular primary calibrator 38
5.5 Cases with an international conventional calibrator that defines the measurand .41
5.6 Cases with metrological traceability supported by an international harmonisation
protocol .44
5.7 Cases for measurands with metrological traceability only to manufacturer’s
internal arbitrarily defined RM(s).46
6 Labelling information to be provided to end-users by the manufacturer .49
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 98/79 .50
Bibliography .52
© ISO 2019 – All rights reserved iii
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oSIST prEN ISO 17511:2019
ISO/DIS 17511:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
This second edition cancels and replaces the first edition (ISO 17511:2003), which has been technically
revised. This new edition of ISO 17511 also cancels and replaces ISO 18153:2003, In vitro diagnostic
medical devices —Measurement of quantities in biological samples — Metrological traceability of values for
catalytic concentration of enzymes assigned to calibrators and control materials, by way of incorporation
of the special requirements for metrologically traceable calibration hierarchies for measurement of
catalytic concentration of enzymes into this new edition. The main changes compared to the previous
edition are as follows:
— inclusion of requirements for calibration hierarchies for catalytic concentration of enzymes
(previously covered in ISO 18153:2003)
— to clarify that final reported values on human samples shall be metrologically traceable to the highest
order available reference, the title and scope were modified to include metrological traceability of
values assigned to human samples
— updated normative references to replace International Vocabulary of Basic and General Terms in
Metrology, 2nd edition, ISO, Geneva (1993), with ISO/IEC Guide 99:2007,International vocabulary of
metrology – Basic and general concepts and associated terms (VIM ) and deleted ISO Guide 35:1989,
Certification of reference materials - General and statistical principles
— revision of clause 4 to clearly define requirements of a manufacturer of an in vitro diagnostic
medical device in establishing and documenting metrological traceability of assigned values (for
calibrators, trueness controls and human samples), while incorporating requirements previously
addressed in clauses 6, 7 and 8 (thus eliminating those sections)
— revision of clause 5 to incorporate additional models of metrologically traceable calibration
hierarchies, especially subclause 5.3 for measurement of catalytic concentration of enzymes
(previously addressed in ISO 18153:2003), and subclause 5.6 for an overview of the concept of
metrological traceability to international harmonisation protocols (addressed in detail in ISO
iv © ISO 2019 – All rights reserved
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oSIST prEN ISO 17511:2019
ISO/DIS 17511:2019(E)
21151, In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin
— Requirements for international harmonisation protocols establishing metrological traceability of
values assigned to calibrators and human samples)
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oSIST prEN ISO 17511:2019
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Introduction
In laboratory medicine, the objective in examining a stated measurand in a human sample is to produce
equivalent results within medically relevant limits, irrespective of the measurement procedure (MP)
used or the laboratory performing the measurement. Equivalent results are important to support
clinical practice guidelines that use laboratory results to assess risk for disease, and/or to diagnose
or make treatment decisions for a medical condition. Equivalent results enable uniform application of
medical decision limits and reference intervals in a way that will reduce errors due to inappropriate
medical decisions and thus improve the quality of medical care for the people served by medical
laboratories and other users of in vitro diagnostic medical devices (IVD MDs). Equivalent results are
also important for analysing results in medical records for the purpose of supporting clinical decisions
and conducting epidemiological investigations.
Equivalent results for human samples can be achieved by establishing traceability of the calibration
of a MP to the highest available reference system component for a given measurand. Metrological
traceability describes the calibration hierarchy and the sequence of value assignments, demonstrating
an unbroken linkage between the measurement result for a human sample up to the highest available
reference system component in the calibration hierarchy. The point at which metrological traceability
begins (i.e. the highest level of metrological traceability in the calibration hierarchy) depends on the
availability of higher order reference measurement procedures (RMPs), reference materials (RMs) or
harmonisation protocols for the stated measurand.
Limitations in implementing metrologically traceable calibrations occur when different IVD MDs
intended for the same measurand do not measure the same or very closely related measureable
quantities. Some measurands of medical interest may be well-defined elements or molecules. Other
measurands are complex and possibly variable mixtures of molecular species with medically relevant
properties in common, but with differences in chemical structures and molecular complexes in varying
proportions, e.g. glycoproteins with multiple isoforms, variant amino acid sequences, molecular
complexes. When the selectivity of an IVD MD is inadequate, sample-specific influence quantities in
human samples due to factors including disease, drugs or other pathological conditions may lead to
erroneous values for the intended measured quantity. Thus, the selectivity of MPs at all levels in the
calibration hierarchy for an IVD MD can influence the ability of a metrologically traceable calibration,
even with traceability to higher order reference system components, to achieve equivalent results
for human samples among different IVD MDs. Since measured values for complex molecular species
are important for medical decisions, calibration hierarchies for IVD MDs, regardless of the molecular
complexity of the measurand, need to be established with careful consideration and recognition of
MP selectivity limitations. To help ensure that metrologically traceable calibrations for IVD MDs with
claims of traceability to the same higher order reference system components are of practical value, the
selectivity of the applicable IVD MDs shall be fit-for-purpose to achieve equivalent results for human
samples among different IVD MDs.
This international standard presents requirements for documenting the calibration hierarchy for a
measured quantity in human samples using a specified IVD MD up to the highest available metrological
reference. This international standard includes models offering potential technical solutions to support
metrological traceability of measured values for measurands in human samples, calibrators and
trueness control materials.
vi © ISO 2019 – All rights reserved
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oSIST prEN ISO 17511:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 17511:2019(E)
In vitro diagnostic medical devices — Requirements for
establishing metrological traceability of values assigned to
calibrators, trueness control materials and human samples
1 Scope
This international standard 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 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 international standard 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 international standard 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;
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oSIST prEN ISO 17511:2019
ISO/DIS 17511:2019(E)
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 1 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 2 Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g. ‘sick’ vs.
‘healthy’), and may also be applied to results differentiated into non-dichotomous categories where the result
categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative
degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual
observation.
2 Normative references
The following document is referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
analyte
component represented in the name of a measurand
constituent of a sample with a measureable property
EXAMPLE In the measurand (measured quantity) "mass of total protein in 24-hour urine", "total protein" is
the analyte (and “mass” is the property.) In "amount of substance concentration of glucose in plasma", "glucose" is
the analyte (and “amount of substance concentration” is the property.)
[SOURCE: Adapted from ISO 18113-1:2009]
3.2
analytical selectivity
selectivity of a measuring system
selectivity
property of a measuring system, used with a specified MP, whereby it provides measured quantity
values for one or more measurands such that the values of each measurand are independent of other
measurands or other quantities in the phenomenon, body, or substance being investigated
EXAMPLE Capability of a measuring system to measure the amount-of-substance concentration of creatinine
in blood plasma without being influenced by the other components present in the sample.
Note 1 to entry: In chemistry, selectivity of a measuring system is usually obtained for quantities with selected
components in concentrations within stated intervals.
Note 2 to entry: Selectivity as used in physics is a concept close to specificity as it is sometimes used in chemistry.
[SOURCE: Adapted from VIM, 4.13]
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oSIST prEN ISO 17511:2019
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3.3
measurement bias
bias
estimate of a systematic measurement error
[SOURCE: VIM, 2.18]
Note 1 to entry: See VIM, 2.17, systematic measurement error
Note 2 to entry: This definition of applies to quantitative measurements only.
3.4
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with associated measurement uncertainties provided by measurement standards (calibrators)
and their corresponding indications and, in a second step, uses this relationship to establish a
measurement result from an indication (for an unknown sample).
Note 1 to entry: A calibration may be expressed by a statement, calibration function, calibration diagram,
calibration curve, or calibration table. In some cases, it may consist of an additive or multiplicative correction of
the indication with associated measurement uncertainty.
Note 2 to entry: Calibration should not be confused with adjustment of a measuring system, often mistakenly
called “self-calibration”, or with verification of calibration.
Note 3 to entry: Often, the first step alone in the above definition is perceived as being calibration.
[SOURCE: Adapted from VIM, 2.39]
3.5
calibration hierarchy
sequence of calibrations from a reference to the final measuring system, where the outcome of each
calibration depends on the outcome of the previous calibration.
Note 1 to entry: Measurement uncertainty necessarily increases along the sequence of calibrations.
Note 2 to entry: The elements of a calibration hierarchy are one or more measurement standards and measuring
systems operated according to MPs.
Note 3 to entry: A comparison between two measurement standards may be viewed as a calibration if the
comparison is used to check and, if necessary, correct the quantity value and measurement uncertainty attributed
to one of the measurement standards.
[SOURCE: VIM, 2.40]
Note 4 to entry: In this document, a calibration hierarchy is defined as a detailed description of the process for
assigning a value of a measurand to a sample using a specified sequence of MPs and RMs (calibrated by higher
order RMs and/or MPs for the same type of quantity, where available.)
Note 5 to entry: For purposes of this definition, a sample includes human samples as well as calibration materials,
EQA materials or other RMs.
3.6
calibrator
measurement standard used in calibration
[SOURCE: VIM, 5.12]
Note 1 to entry: In this international standard, calibrator is synonymous with calibration material.
Note 2 to entry: A calibrator is a measurement standard used in the calibration of a measuring system according
to a specified MP.
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ISO/DIS 17511:2019(E)
3.7
catalytic activity
property of a component corresponding to the catalysed substance rate of conversion of a specified
chemical reaction, in a specified measurement system
[SOURCE: Adapted from (26)]
Note 1 to entry: In this standard the "component" is an enzyme.
Note 2 to entry: The quantity "catalytic activity" relates to an amount of active enzyme, not its concentration, see
subclause 3.8.
-1
Note 3 to entry: The coherent derived SI unit is "katal" (kat), equal to "mole per second" (mol s ).
Note 4 to entry: The MP is an essential element of the definition of the measurand for the quantity "catalytic
activity".
Note 5 to entry: In many instances, instead of the conversion rate of the substrate ascribed in the short name
of the enzyme analyte, e.g. "creatine" in "creatine kinase", the conversion rate of an indicator substance as
substrate of a combined reaction is measured. (In these circumstances) the measurand should be defined as
'catalytic activity of the enzyme as measured by the conversion rate of an indicator substance in a specified
system according to a given MP', e.g. 'catalytic activity of creatine kinase as measured by the rate of conversion of
NADP+ in the IFCC reference procedure in human serum'.
[SOURCE: Adapted from ISO 18153:2003, 3.2]
3.8
catalytic-activity concentration
catalytic concentration
catalytic activity of a component divided by volume of the original system[SOURCE: Adapted from [26]]
-3
Note 1 to entry: The coherent derived SI unit is "katal per cubic metre" or "mole per second cubic metre" (kat m
-1 -3
= mol s m ). In laboratory medicine, the unit of volume can be chosen to be "litre" (L).
Note 2 to entry: In this standard the "component" is an enzyme and the "original system" can be, for example,
blood plasma.
[SOURCE: Adapted from ISO 18153:2003, 3.3]
3.9
certified reference material
CRM
RM accompanied by documentation issued by an authoritative body and providing one or more
specified property values with associated uncertainties and traceabilities, using valid procedures.
EXAMPLE Human serum with assigned quantity value for the concentration of cholesterol and associated
measurement uncertainty stated in an accompanying certificate, used as a calibrator or measurement trueness
control material.
Note 1 to entry: ‘Documentation’ is given in the form of a ‘certificate’ (see ISO Guide 31).
Note 2 to entry: Procedures for the production and certification of CRMs are given in ISO 17034:2016 and ISO
Guide 35:2017.
Note 3 to entry: In this definition, “uncertainty” covers both ‘measurement uncertainty’ and ‘uncertainty
associated with the value of a nominal property’, such as for identity and sequence. “Traceability” covers both
‘metrological traceability of a quantity value’ and ‘traceability of a nominal property value’.
Note 4 to entry: Specified quantity values of CRMs require metrological traceability with associated measurement
[27]
uncertainty .
[27]
Note 5 to entry: ISO/REMCO has an analogous definition but uses the modifiers “metrological” and
“metrologically” to refer to both quantities and nominal properties.
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[SOURCE: Adapted from VIM, 5.14]
Note 6 to entry: Specific requirements for CRMs and the content of supporting documentation (in the field of
...
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