National foreword

This British Standard is the UK implementation of EN ISO 15197:2003, incorporating corrigendum March 2005. It is identical with ISO 15197:2003.

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 27 May 2003

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.

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 relative or absolute deficiency in insulin secretion or by insulin resistance leading to abnormal 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 laypersons. The primary objectives are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance to this International Standard.

Performance criteria for blood-glucose monitoring systems were established from the accuracy (precision and trueness) required for individual glucose results. System accuracy criteria, also known in the in vitro diagnostics (IVD) industry as total error criteria (see NCCLS EP21-P^[35]), are used in this International Standard because some of the metrological terms commonly used in International Standards (e.g. uncertainty) would not be familiar to lay users. System accuracy, which is affected by systematic bias and measurement uncertainty, describes the degree to which the individual results produced by a glucose monitoring system agree with the true glucose values when the system is used as intended by laypersons.

The criteria for system accuracy are based on three considerations (see References [2] to [21] in the Bibliography):

the effectiveness of current technology for monitoring patients with diabetes mellitus, as demonstrated in clinical outcome studies using state-of-the-art monitoring devices;
recommendations of diabetes researchers as well as existing product standards and regulatory guidelines;
the state-of-the-art of currently available technology, as evidenced by the performance of existing commercial products.

In arriving at the performance criteria, desirable goals had to be weighed against the capabilities of existing devices (the current state-of-the-art) and their effectiveness in clinical outcome studies. It was decided that overly demanding performance requirements would cause manufacturers to focus design improvements on analytical performance at the expense of other important attributes. For example, frequency of testing by diabetic patients can be as important as the accuracy of an individual result, and greater convenience of glucose self-testing improves patient compliance. The system accuracy criteria define the minimum acceptable performance of a blood-glucose measuring device intended for self-monitoring.

Future advances in technology are expected, which should result in improved performance of glucose monitoring devices. Such performance improvements will be driven by the competitive marketplace, particularly through reduction of dependence on user technique.

Requirements that are unique to self-monitoring devices for blood-glucose, including the content of information supplied by the manufacturer, are addressed in this International Standard. General requirements that apply to all in vitro diagnostic medical devices and are covered by other standards [e.g. ISO 13485 and ISO 14971] are incorporated by reference where appropriate.

Although this International Standard does not apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative measurement procedures), it may be useful as a guide for developing procedures to evaluate the performance of such systems.

This European Standard was approved by CEN on 25 April 2003.

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 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 Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document (EN ISO 15197:2003) has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro 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 November 2003, and conflicting national standards shall be withdrawn at the latest by November 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(s), see informative Annex ZB, 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 15197:2003 has been approved by CEN as EN ISO 15197:2003 without any modifications.

NOTE: Normative references to International Standards are listed in Annex ZA (normative).

1 Scope

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons 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, or
apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

2 Normative references

3 Terms and definitions

4 Design and development

4.1 General requirements

4.2 Safety

4.3 Traceability

4.4 Ergonomic/human factor aspects

4.5 Risk analysis

4.6 User verification

5 Information supplied by the manufacturer

5.1 Labels for the blood-glucose meter

5.2 Instructions for use for the blood-glucose monitoring system

5.3 Labels for the reagent system and control material

5.4 Instructions for use for reagents and control material

6 Safety and reliability testing

6.1 General requirements

6.2 Protection against electric shock

6.3 Protection against mechanical hazards

6.4 Electromagnetic compatibility

6.5 Resistance to heat

6.6 Resistance to moisture and liquids

6.7 Protection against liberated gases, explosion and implosion

6.8 Meter components

6.9 Performance test

6.10 Mechanical resistance to shock, vibration and impact

6.11 Equipment temperature exposure limits

6.12 Equipment humidity exposure test protocol

6.13 Reagent storage and use testing

7 Analytical performance evaluation

7.1 General requirements

7.2 Precision evaluation

7.3 System accuracy evaluation

7.4 Minimum acceptable system accuracy

8 User performance evaluation

8.1 General

8.2 Evaluation sites

8.3 User evaluation

8.4 Evaluation of instructions for use

Bibliography

BS EN ISO 15197:2003

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

Published:

27 May 2003

Withdrawn:

30 Jun 2013