National foreword

This British Standard is the UK implementation of EN ISO 23640:2015. It is identical to ISO 23640:2011. It supersedes BS EN ISO 23640:2013 which is withdrawn.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 23640:2011 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 23640:2015 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of an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest by June 2018.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 23640:2013.

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.

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this standard ‘within the meaning of Annex ZA’, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.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 23640 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.

Introduction

One important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents is initially designing the stability of a product, then determining and verifying the expiry date of the product that is placed on the market. To determine shelf life, transport stability, and in-use stability, the manufacturer performs an evaluation. In order to provide this important information to the customer, the manufacturer identifies critical factors that might influence stability of the IVD reagent and carefully evaluates these characteristics. Stability of the IVD reagent affects the performance of the device and therefore has an impact on patient results.

It is the manufacturer’s responsibility to determine and monitor stability of IVD reagents to ensure that performance characteristics of the product are maintained. This is best accomplished by developing a stability evaluation protocol, and producing valid data and analysis to establish appropriate shelf life, transport limitations and in-use stability information, which are then provided to the customers.

The basis for this ISO standard is EN 13640, Stability testing of in vitro diagnostic reagents^[2].

Endorsement notice

The text of ISO 23640:2011 has been approved by CEN as EN ISO 23640:2015 without any modification.

1 Scope

This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. This International Standard can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.

This International Standard specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:

the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
the establishment of stability of the IVD reagent in use after the first opening of the primary container;
EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.
the monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.

This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.

2 Normative references

3 Terms and definitions

4 General requirements

4.1 General principles

4.2 Protocol

4.3 Stability reports

5 Procedures

5.1 General

5.2 Real time stability evaluation

5.3 Accelerated stability evaluation

Bibliography

BS EN ISO 23640:2015

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

Current, Under Review

Published:

30 Jun 2015