SIST EN ISO 15197:2013
(Main)In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not: - provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, - pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, - address the medical aspects of diabetes mellitus management, - apply to measurement procedures with measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures), or to continuous glucose monitoring systems, - apply to glucose meters intended for use in medical applications other than self-testing for the management of diabetes mellitus.
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung beim Diabetes mellitus (ISO 15197:2013)
Die vorliegende Internationale Norm legt Anforderungen an In vitro Glukosemesssysteme zur Messung von Glukosekonzent¬rationen in Kapillarblutproben für spezifische Design-Verifizierungsverfahren und zur Validierung der Leistungsfähigkeit durch die vorgesehenen Anwender fest. Diese Systeme sind für die Selbstmessung durch Laien zur Führung des Diabetes mellitus vorgesehen.
Diese Internationale Norm gilt für die Hersteller derartiger Systeme und für diejenigen sonstigen Organisationen (z. B. Zulassungsbehörden und Institutionen zur Konformitätsbeurteilung), die für die Beurteilung der Leistungsfähigkeit dieser Systeme verantwortlich sind.
Diese Internationale Norm
- liefert keine umfassende Bewertung aller möglichen Faktoren, die die Leistungsfähigkeit dieser Systeme beeinflussen können;
- gilt nicht für die Glukosekonzentrationsmessung zur Diagnose des Diabetes mellitus;
- behandelt nicht die medizinischen Aspekte der Führung des Diabetes mellitus;
- gilt nicht für Messverfahren, bei denen die Messwerte auf einer Ordinalskale dargestellt werden (z. B. visuelle, halbquantitative Messverfahren) oder für kontinuierliche Glukosemesssysteme;
- gilt nicht für Blutzuckermessgeräte in medizinischen Applikationen, die nicht für den Gebrauch der Selbstüberwachung zum Management von Diabetes mellitus gedacht sind.
Systèmes d'essais de diagnostic in vitro - Exigences relatives aux systèmes d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré (ISO 15197:2013)
Diagnostični preskusni sistemi in vitro - Zahteve za sisteme nadzora glukoze v krvi za samopreskušanje pri obravnavi sladkorne bolezni (ISO 15197:2013)
Ta mednarodni standard določa zahteve za sisteme nadzora glukoze v krvi in vitro, ki merijo koncentracije glukoze v vzorcih kapilarne krvi, za posebne postopke overjanja modelov in za preverjanje delovanja s strani predvidenih uporabnikov. Ti sistemi so namenjeni za samopreskušanje pri obravnavi sladkorne bolezni, torej za laično uporabo. Ta mednarodni standard velja za proizvajalce takšnih sistemov in druge organizacije (npr. regulativni organi in organi za ugotavljanje skladnosti), odgovorne za ocenjevanje delovanja takšnih sistemov. Ta mednarodni standard: – ne zagotavlja celovitega vrednotenja morebitnih dejavnikov, ki bi lahko vplivali na delovanje teh sistemov; – ne zadeva merjenja koncentracije glukoze z namenom diagnosticiranja sladkorne bolezni; – ne obravnava zdravstvenih vidikov obravnave sladkorne bolezni; – ne velja za postopke merjenja z izmerjenimi vrednostmi po razvrstitveni lestvici (npr. vizualni polkvantitativni postopki merjenja) ali za sisteme neprekinjenega nadzora glukoze; – ne velja za merilnike glukoze, ki so namenjeni za uporabo v medicini za nadzor sladkorne bolezni, ki ga ne izvaja oboleli sam.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15197:2013
01-september-2013
1DGRPHãþD
SIST EN ISO 15197:2003
SIST EN ISO 15197:2003/AC:2005
'LDJQRVWLþQLSUHVNXVQLVLVWHPLLQYLWUR=DKWHYH]DVLVWHPHQDG]RUDJOXNR]HYNUYL
]DVDPRSUHVNXãDQMHSULREUDYQDYLVODGNRUQHEROH]QL ,62
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus (ISO 15197:2013)
Testsysteme für die In-vitro-Diagnostik - Anforderungen an Blutzuckermesssysteme zur
Eigenanwendung beim Diabetes mellitus (ISO 15197:2013)
Systèmes d'essais de diagnostic in vitro - Exigences relatives aux systèmes
d'autosurveillance de la glycémie destinés à la prise en charge du diabète sucré (ISO
15197:2013)
Ta slovenski standard je istoveten z: EN ISO 15197:2013
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
SIST EN ISO 15197:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15197:2013
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SIST EN ISO 15197:2013
EUROPEAN STANDARD
EN ISO 15197
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2013
ICS 11.100.10 Supersedes EN ISO 15197:2003
English Version
In vitro diagnostic test systems - Requirements for blood-
glucose monitoring systems for self-testing in managing
diabetes mellitus (ISO 15197:2013)
Systèmes d'essais de diagnostic in vitro - Exigences Testsysteme für die In-vitro-Diagnostik - Anforderungen an
relatives aux systèmes d'autosurveillance de la glycémie Blutzuckermesssysteme zur Eigenanwendung beim
destinés à la prise en charge du diabète sucré (ISO Diabetes mellitus (ISO 15197:2013)
15197:2013)
This European Standard was approved by CEN on 15 May 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15197:2013: E
worldwide for CEN national Members.
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SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC in vitro diagnostic medical devices .4
2
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SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
Foreword
This document (EN ISO 15197:2013) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with the 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 November 2013, and conflicting national standards shall be withdrawn
at the latest by November 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15197:2003.
This document has been prepared under a 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, see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2013 without any modification.
3
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SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC in vitro diagnostic medical
devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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 Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 98/79/EC in vitro
diagnostic medical devices
Essential requirements
Clauses of this international
(ERs) of Qualifying Comments/Notes
Standard
Directive 98/79/EC
4.2, 6 A.3
4.3, 4.4 A.4 Aspects related to mechanical stress are
not covered
4.3, 4.4, 6.5, 7 A.5 Packaging aspects are not covered.
4.3, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8, 5.10, B.3.3
5.11, 5.12
5.7 B.3.4
4.4 B.3.6
6, 7 B.4.1
6 B.6.1
5.2 B.6.3
5.3, 5.6 B.6.4.1 “Life time resistance to mechanical stress”
is not covered.
5.2 B.6.4.4 Clause 5.2 only partially covers this ER,
as it deals only with electrical terminals
and connectors.
4.4, 7, 8 B.7.1
7 B.8.1 The sixth paragraph of this ER
(translation into other languages) is not
covered.
7 B.8.2 Covered by reference to EN ISO 18113-1.
4
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SIST EN ISO 15197:2013
EN ISO 15197:2013 (E)
7 B.8.3 This aspect is covered by normative
reference to EN ISO 18113-4 and
EN ISO 18113-5. However, essential
requirement B.8.3 of Directive 98/79/EC
should be consulted for a comprehensive
list of the information required
7 B.8.4 Not all the requirements of ER B.8.4 are
covered, but only those required by
EN ISO 18113-1, EN ISO 18113-4 and
EN ISO 18113-5, related to IVD medical
devices for self – testing
7 B.8.4(a) If the manufacturer is not located in the
EU, the manufacturer is required to
designate an “EC Authorised
Representative” established in the EU. In
such cases and to comply with this ER,
the name and address of the Authorised
Representative are required
7 B.8.4(d) Full compliance with this ER requires the
use of the symbol [LOT] and the symbol
[SN], as applicable.
7 B.8.6 Covered by normative reference to
EN ISO 18113-4 and EN ISO 18113-5.
4.2, 7 B.8.7 Not all the requirements of this ER are
covered, but only those required by the
labelling standards EN ISO 18113-1,
EN ISO 18113-4 and EN ISO 18113-5,
related to IVD medical devices for self –
testing
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
5
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SIST EN ISO 15197:2013
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SIST EN ISO 15197:2013
INTERNATIONAL ISO
STANDARD 15197
Second edition
2013-05-15
In vitro diagnostic test systems —
Requirements for blood-glucose
monitoring systems for self-testing in
managing diabetes mellitus
Systèmes d’essais de diagnostic in vitro — Exigences relatives aux
systèmes d’autosurveillance de la glycémie destinés à la prise en
charge du diabète sucré
Reference number
ISO 15197:2013(E)
©
ISO 2013
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SIST EN ISO 15197:2013
ISO 15197:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, 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 on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
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SIST EN ISO 15197:2013
ISO 15197:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Design and development . 8
4.1 General requirements . 8
4.2 Metrological traceability . 8
4.3 Safety and risk management . 9
4.4 Ergonomics and human factors .10
4.5 User verification requirements .10
5 Safety and reliability testing .10
5.1 General requirements .10
5.2 Protection against electric shock .11
5.3 Protection against mechanical hazards .11
5.4 Electromagnetic compatibility .11
5.5 Resistance to heat .11
5.6 Resistance to moisture and liquids .11
5.7 Protection against liberated gases, explosion and implosion.12
5.8 Meter components .12
5.9 Performance test .12
5.10 Mechanical resistance to vibration and shock .12
5.11 Equipment temperature exposure limits for storage .13
5.12 Equipment humidity exposure limits for storage .13
6 Analytical performance evaluation .14
6.1 General requirements .14
6.2 Measurement precision .16
6.3 System accuracy .19
6.4 Influence quantities .25
6.5 Stability of reagents and materials .30
7 Information supplied by the manufacturer .30
7.1 General requirements .30
7.2 Performance characteristics.31
7.3 Options for supplying instructions for use .31
8 User performance evaluation .31
8.1 General requirements .31
8.2 Acceptance criteria and evaluation of results .32
8.3 Selection and preparation of subjects .32
8.4 Execution of study protocol .32
8.5 Glucose reference values .33
8.6 Human factors .33
8.7 Data analysis and presentation of results .33
8.8 Evaluation of instructions for use .34
Annex A (informative) Possible interfering substances .35
Annex B (informative) Traceability chain .36
Annex C (informative) Rationale for the analytical performance requirements .38
Bibliography
.45
© ISO 2013 – All rights reserved iii
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SIST EN ISO 15197:2013
ISO 15197:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 15197 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 15197:2003), the clauses, subclauses and
annexes of which have been technically revised.
iv © ISO 2013 – All rights reserved
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SIST EN ISO 15197:2013
ISO 15197:2013(E)
Introduction
Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by
individuals affected by diabetes mellitus. Diabetes mellitus is caused by a deficiency in insulin secretion
or by insulin resistance leading to abnormally high concentrations of glucose in the blood, which may
result in acute and chronic health complications. When used properly, a glucose monitoring system
allows the user to monitor and take action to control the concentration of glucose present in the blood.
This International Standard is intended for blood-glucose monitoring systems used by lay persons. The
primary objectives are to establish requirements that result in acceptable performance and to specify
procedures for demonstrating conformance to this International Standard.
Minimum performance criteria for blood-glucose monitoring systems were established from the
analytical requirements (precision and trueness) for individual glucose measurement results. “System
accuracy” is the term used in this International Standard to communicate the analytical capability of
a blood-glucose monitoring system to the intended users (i.e. lay persons), who would not be familiar
with metrological terms commonly used in laboratory medicine. System accuracy describes the ability
of a glucose monitoring system to produce measurement results that agree with true glucose values
when the system is used as intended. The concept of “system accuracy” includes measurement bias and
measurement precision.
The requirements for system accuracy are based on three considerations:
— the effectiveness of current technology for monitoring patients with diabetes mellitus;
— recommendations of diabetes researchers as well as existing product standards and regulatory
guidelines; and
— the state-of-the-art of blood-glucose monitoring technology.
In arriving at the performance requirements specified in the second edition of this International
Standard, desirable goals had to be weighed against the capabilities of existing blood-glucose
monitoring technology. The revised performance criteria in this edition are the result of improvements
in technology since publication of the first edition. The considerations that formed the basis for the
minimum acceptable analytical performance of a blood-glucose measuring device intended for self-
monitoring are described in Annex C.
Requirements that are unique to self-monitoring devices for blood-glucose are addressed in this
International Standard. Requirements that apply in general to all in vitro diagnostic medical devices are
incorporated by reference to other standards where appropriate.
Although this International Standard does not apply to glucose monitoring systems that provide
measured values on an ordinal scale (e.g. visual, semiquantitative measurement procedures) or medical
devices that measure blood-glucose continuously for self-monitoring, it may be useful as a guide for
developing procedures to evaluate the performance of such systems.
© ISO 2013 – All rights reserved v
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SIST EN ISO 15197:2013
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SIST EN ISO 15197:2013
INTERNATIONAL STANDARD ISO 15197:2013(E)
In vitro diagnostic test systems — Requirements for blood-
glucose monitoring systems for self-testing in managing
diabetes mellitus
1 Scope
This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples, for specific design verification procedures and for
the validation of performance by the intended users. These systems are intended for self-measurement
by lay persons for management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations
(e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing
the performance of these systems.
This International Standard does not:
— provide a comprehensive evaluation of all possible factors that could affect the performance of
these systems,
— pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
— address the medical aspects of diabetes mellitus management,
— apply to measurement procedures with measured values on an ordinal scale (e.g. visual,
semiquantitative measurement procedures), or to continuous glucose monitoring systems,
— apply to glucose meters intended for use in medical applications other than self-testing for the
management of diabetes mellitus
2 Normative references
The following referenced documents are indispensable for the application 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 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values assigned to calibrators and control materials
ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 1: Terms, definitions and general requirements
ISO 18113-4, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-5, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 5: In vitro diagnostic instruments for self-testing
ISO 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and
guidance
© ISO 2013 – All rights reserved 1
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SIST EN ISO 15197:2013
ISO 15197:2013(E)
IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use —
Part 1: General requirements
IEC 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-1, Electrical equipment for measurement, control and laboratory use — EMC requirements —
Part 1: General requirements
IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use — EMC requirements —
Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment
IEC 62366, Medical devices — Application of usability engineering to medical devices
EN 13612, Performance evaluation of in vitro diagnostic medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18113-1 and the following apply.
3.1
blood-glucose monitoring system
measuring system consisting of a portable instrument and reagents used for the in vitro monitoring of
glucose concentrations in blood
Note 1 to entry: Blood-glucose monitoring systems measure glucose in capillary blood samples, but can express
measured values as either the glucose concentration in capillary blood or the equivalent glucose concentration
in capillary plasma. Concentrations in this International Standard refer to the type of measured values reported
by the system.
3.2
blood-glucose meter
component of a blood-glucose monitoring system that converts the product of a chemical reaction into
the glucose concentration of the sample
3.3
capillary blood-sample
blood sample collected by skin puncture
Note 1 to entry: A finger punctured by a lancet is commonly called a “fingerstick”.
3.4
commutability of a reference material
property of a reference material, demonstrated by the closeness of agreement between the relation among
the measurement results for a stated quantity in this material, obtained according to two given measurement
procedures, and the relation obtained among the measurement results for other specified materials
Note 1 to entry: The reference material in question is usually a calibrator and the other specified materials are
usually routine samples.
Note 2 to entry: The measurement procedures referred to in the definition are the one preceding and the one following
the reference material (calibrator) in question in a calibration hierarchy. See ISO 17511 for further information.
Note 3 to entry: The stability of commutable reference materials is monitored regularly.
[ISO/IEC Guide 99:2007, definition 5.15]
Note 4 to entry: Although blood would be the ideal matrix for reference materials for blood-glucose monitoring
devices, such materials are not available at this time.
2 © ISO 2013 – All rights reserved
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SIST EN ISO 15197:2013
ISO 15197:2013(E)
3.5
consecutive selection method
sampling method for a research study in which all subjects that meet the enrolment criteria are
...
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