In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

ISO 15197:2013 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.
ISO 15197:2013 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.

Testsysteme für die In­vitro­Diagnostik - Anforderungen an Blutzuckermesssysteme zur Eigenanwendung bei 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)

L'ISO 15197:2013 spécifie les exigences relatives aux systèmes de surveillance de la glycémie in vitro dans des échantillons de sang capillaire, aux procédures de vérification particulières, ainsi qu'à la validation de la performance par les utilisateurs prévus. Ces systèmes sont destinés à l'autosurveillance du diabète sucré par des personnes non initiées.
L'ISO 15197:2013 est destinée aux fabricants de ces systèmes ainsi qu'aux organismes (autorités réglementaires et organismes d'évaluation de la conformité) ayant la responsabilité de l'évaluation des performances de ces systèmes.

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

Status
Published
Publication Date
09-Jun-2015
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
10-Jun-2015
Completion Date
10-Jun-2015

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SLOVENSKI STANDARD
SIST EN ISO 15197:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 15197:2013

'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 In­vitro­Diagnostik - Anforderungen an Blutzuckermesssysteme zur

Eigenanwendung bei 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 15197:2015
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
11.100.30 Analiza krvi in urina Analysis of blood and urine
SIST EN ISO 15197:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 15197:2015
---------------------- Page: 2 ----------------------
SIST EN ISO 15197:2015
EUROPEAN STANDARD
EN ISO 15197
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.100.10 Supersedes EN ISO 15197:2013
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 bei Diabetes

destinés à la prise en charge du diabète sucré (ISO mellitus (ISO 15197:2013)
15197:2013)
This European Standard was approved by CEN on 3 June 2015.

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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15197:2015 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 15197:2015
EN ISO 15197:2015 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 98/79/EC ..............................................................................................4

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SIST EN ISO 15197:2015
EN ISO 15197:2015 (E)
Foreword

The text of ISO 15197:2013 has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory

testing and in vitro diagnostic test systems” of the International Organization for Standardization (ISO) and has

been taken over as EN ISO 15197:2015 by 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 2015, and conflicting national standards shall be withdrawn

at the latest by June 2018.

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 15197:2013.

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.

The following referenced documents are indispensable for the application of this document. For undated

references, the edition of the referenced document (including any amendments) listed below 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 shall 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 undated normative references and dated EN and ISO standards

Normative references as listed Equivalent dated standard
in Clause 2
EN ISO
ISO 13485 EN ISO 13485:2012 + AC:2012 ISO 13485:2003 + Cor. 1:2009
ISO 14971 EN ISO 14971:2012 ISO 14971:2007, Corrected version
2007-10-01
ISO 17511 EN ISO 17511:2003 ISO 17511:2003
ISO 18113-1 EN ISO 18113-1:2011 ISO 18113-1:2009
ISO 18113-4 EN ISO 18113-4:2011 ISO 18113-4:2009
ISO 18113-5 EN ISO 18113-5:2011 ISO 18113-5:2009
ISO 23640 EN ISO 23640:2014 ISO 23640:2011
IEC 60068-2-64 EN 60068-2-64:2008 IEC 60068-2-64:2008
IEC 61010-1 EN 61010-1:2010 IEC 61010-1:2010 + Cor. :2011
IEC 61010-2-101 EN 61010-2-101:2002 IEC 61010-2-101:2002
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SIST EN ISO 15197:2015
EN ISO 15197:2015 (E)
IEC 61326-1 EN 61326-1:2013 IEC 61326-1:2012
IEC 61326-2-6 EN 61326-2-6:2013 IEC 61326-2-6:2012
IEC 62366 EN 62366:2008 IEC 62366:2007
EN 13612 EN 13612:2002

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 15197:2015 without any modification.

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SIST EN ISO 15197:2015
EN ISO 15197:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC

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

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 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 Essential Requirements of that Directive 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 Directive 98/79/EC. This means that risks have to be reduced ‘as far

as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the

corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.

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 an Essential 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 Directive 98/79/EC

Essential Requirements
Clause(s)/sub-clause(s) of this EN (ERs) of Qualifying remarks/notes
Directive 98/79/EC
4.3 A.2 Referenced clause covers only the first
bullet point of the ER.
Risk management of blood glucose
monitoring instrument is not covered by
the referenced clause.
Directive 98/79/EC requires
manufacturers to eliminate or reduce risks
as far as possible.
For managing risks associated with in
vitro diagnostic medical devices EN
ISO 14971:2012 should be applied.
5.11, 5.12 B.3.3 Referenced clauses cover only the
temperature (5.11) and humidity (5.12)
aspects of the ER (in second bullet)
4.4 B.3.6
6, 7.2 B.4.1 This ER is covered when accuracy limits
are stated by the manufacturer in the IFU.
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SIST EN ISO 15197:2015
EN ISO 15197:2015 (E)
4.5 B.7.2

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within

the scope of this standard.
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SIST EN ISO 15197:2015
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 15197:2015
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
Case postale 56 • CH-1211 Geneva 20
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 15197:2015
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 15197:2015
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 15197:2015
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 15197:2015
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SIST EN ISO 15197:2015
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 15197:2015
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

...

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