National foreword

This British Standard is the official English language version of EN 13641:2002.

The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

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

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled "International Standards Correspondence Index", or by using the "Search" facility of the BSI Electronic Catalogue or of British Standards Online.

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

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 27 May 2002

This European Standard was approved by CEN on 5 January 2002.

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, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document EN 13641:2002 has been prepared 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 November 2002, and conflicting national standards shall be withdrawn at the latest by November 2002.

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 ZA, which is an integral part of this document.

This standard includes a Bibliography.

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, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Introduction

Although medical laboratory staff routinely handle specimens that are potentially infectious and appropriate protective measures and safety procedures have to be followed, according to the provisions of the Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) (see Bibliography, [1]) the additional risk of accidental infection caused by IVD MDs containing infectious or potentially infectious material is to be reduced to a minimum. This requirement of the EU Directive is an essential requirement relating to the design and manufacture of IVD MDs. Manufacturers are obliged to ensure by appropriate design features and manufacturing procedures that the risk of infection presented by the product itself is minimal. The EU Directive does not specifically address the following aspects which are covered by specific international, European and/or national legislation:

general aspects of workers' protection and the measures that have to be implemented when infectious or potentially infectious materials are handled in laboratories or manufacturing sites,
transportation of infectious goods,
disposal routes and processes.

1 Scope

This European Standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.

The standard does not apply to the following:

instruments and specimen receptacles;
NOTE 1 The prevention of infection due to handling of biological materials throughout such equipment is addressed in other relevant International and/or European Standards.
general aspects of workers' protection;
transportation of infectious goods;
disposal measures.
NOTE 2 Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

2 Normative references

3 Terms and definitions

4 Requirements related to design and manufacture

4.1 General

4.2 Use of infectious biological materials or potentially infectious biological materials

4.3 Raw material specifications

4.4 Manufacturing process

5 Information supplied by the manufacturer

Bibliography

BS EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Current, Under Review

Published:

27 May 2002