National foreword

This British Standard is the UK implementation of EN ISO 15197:2015. It is identical to ISO 15197:2013. It supersedes BS EN ISO 15197:2013 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2015.

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of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by June 2018.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this standard ‘within the meaning of Annex ZA’, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.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.

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.

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.

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.

Endorsement notice

The text of ISO 15197:2013 has been approved by CEN as EN ISO 15197:2015 without any modification.

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

3 Terms and definitions

4 Design and development

4.1 General requirements

4.2 Metrological traceability

4.3 Safety and risk management

4.4 Ergonomics and human factors

4.5 User verification requirements

5 Safety and reliability testing

5.1 General requirements

5.2 Protection against electric shock

5.3 Protection against mechanical hazards

5.4 Electromagnetic compatibility

5.5 Resistance to heat

5.6 Resistance to moisture and liquids

5.7 Protection against liberated gases, explosion and implosion

5.8 Meter components

5.9 Performance test

5.10 Mechanical resistance to vibration and shock

5.11 Equipment temperature exposure limits for storage

5.12 Equipment humidity exposure limits for storage

6 Analytical performance evaluation

6.1 General requirements

6.2 Measurement precision

6.3 System accuracy

6.4 Influence quantities

6.5 Stability of reagents and materials

7 Information supplied by the manufacturer

7.1 General requirements

7.2 Performance characteristics

7.3 Options for supplying instructions for use

8 User performance evaluation

8.1 General requirements

8.2 Acceptance criteria and evaluation of results

8.3 Selection and preparation of subjects

8.4 Execution of study protocol

8.5 Glucose reference values

8.6 Human factors

8.7 Data analysis and presentation of results

8.8 Evaluation of instructions for use

Bibliography

BS EN ISO 15197:2015

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Current, Under Review

Published:

30 Jun 2015