EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE   For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs to
- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.

Leistungsbewertung von In-vitro-Diagnostika

Diese Europäische Norm gilt für die Leistungsbewertung von In-vitro-Diagnostika, einschließlich solcher zur Eigenanwendung. Sie legt die Verantwortlichkeiten und allgemeinen Erfordernisse zur Planung, Durchführung, Auswertung und Dokumentation einer Leistungsbewertungsstudie durch den Hersteller fest. Spezielle Studienpläne für bestimmte In-vitro-Diagnostika oder einen speziellen Gebrauch sind nicht Gegenstand dieser Norm.
ANMERKUNG   Eine Auswahl von Veröffentlichungen über spezielle Studienpläne findet sich in den Literaturhinweisen.
Unterhält ein Hersteller ein Qualitätssicherungssystem, bezieht sich diese Norm auf die Erfüllung der Festlegungen zur "Entwicklungsvalidierung" und "Designänderung" nach EN ISO 9001, EN 46001 und EN 928, wobei die letztgenannte Norm speziell In-vitro-Diagnostika behandelt.
Diese Norm gilt insbesondere für In-vitro-Diagnostika, um
¾ für benannte Stellen und nationale Behörden mit den Ergebnissen einer Leistungsbewertung den Nachweis zu erbringen, dass das In-vitro-Diagnostikum die vom Hersteller beschriebenen Anforderungen erfüllt,
¾ angemessene Angaben aus den Leistungsbewertungsstudien zu erstellen, die aus geeigneten Studien oder der verfügbaren Literatur gewonnen wurden,
¾ die Anforderungen eines Qualitätssicherungssystems zur Entwicklungsvalidierung zu erfüllen.

Evaluation des performances des dispositifs médicaux de diagnostic in vitro

La présente Norme européenne s'applique à l'évaluation des performances des dispositifs médicaux de diagnostic in vitro, y compris ceux utilisés pour l'auto-test. Elle spécifie les responsabilités et les exigences générales relatives à la planification, la conduite, l'estimation et la documentation d'une étude d'évaluation des performances par le fabricant. Elle ne s'applique pas aux plans d'évaluation spécifiques à certains dispositifs ou à un usage particulier.
NOTE   Voir dans la bibliographie une sélection de publications concernant des plans d'évaluation spécifiques.
Si le fabricant applique un système qualité, la présente norme permet de satisfaire aux exigences de la « validation de la conception » et des « modifications de la conception » décrites dans l'EN ISO 9001, l'EN 46001 et l'EN 928, surtout en ce qui concerne la nature et l'utilisation des dispositifs médicaux de diagnostic in vitro.
La présente norme s'applique aux dispositifs médicaux de diagnostic in vitro et a pour objet :
¾ de démontrer aux organismes notifiés et aux autorités nationales, sur la base des résultats d'une évaluation de performances, que les performances du dispositif correspondent à celles déclarées par le fabricant ;
¾ de collecter des données adéquates pour évaluer les performances, à partir d'études appropriées ou d'une documentation disponible ; et
¾ de satisfaire aux exigences d'un système qualité concernant la validation de la conception.

Ovrednotenje diagnostičnih medicinskih pripomočkov lastnosti in vitro

General Information

• Status: Published
• Publication Date: 19-Mar-2002
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 1 - Labelling and performance evaluation
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 20-Feb-2020
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices

Relations

• Corrected By: EN 13612:2002/AC:2002 - Performance evaluation of in vitro diagnostic medical devices
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Performance evaluation of in vitro diagnostic medical devicesLWUREvaluation des performances des dispositifs médicaux de diagnostic in vitroLeistungsbewertung von In-vitro-DiagnostikaTa slovenski standard je istoveten z:EN 13612:2002SIST EN 13612:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13612:200201-november-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13612March 2002ICS 11.100English versionPerformance evaluation of in vitro diagnostic medical devicesDétermination des performances des dispositifs médicauxpour diagnostic in vitroLeistungsbewertung von In-vitro-DiagnostikaThis 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.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.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13612:2002 E

Scope.52
Terms and definitions.53
General requirements for the performance evaluation.63.1
Responsibilities and resources.63.2
Documentation.73.3
Final assessment and review.74
Organisation of a performance evaluation study.74.1
Preconditions.74.2
Evaluation plan.74.3
Sites and resources.84.4
Basic design information.84.5
Experimental design.94.6
Performance study records.94.7
Observations and unexpected outcomes.104.8
Evaluation report.105
Modifications during the performance evaluation study.106
Re-evaluation.107
Protection and safety of probands.11Annex ZA (informative)
Clauses of this European Standard addressing essential requirementsor other provisions of EU Directives.12Bibliography.13

ScopeThis European Standard applies to the performance evaluation of in vitro diagnostic medical devices(IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirementsfor the planning, conduct, assessment and documentation of a performance evaluation study by themanufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.NOTEFor a selection of publications on specific evaluation plans see Bibliography.Where a manufacturer maintains a quality system this standard addresses the compliance with"design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928especially considering the nature and use of IVD MDs.In particular, this standard applies to IVD MDs to- show evidence to notified bodies and national authorities by results of a performance evaluation thatthe IVD MD performs as claimed by the manufacturer,- establish adequate performance evaluation data originating from appropriate studies or resultingfrom available literature, and to- satisfy the requirements of a quality system for design validation.2
Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.2.1co-ordinator of a performance evaluation studyperson empowered by the manufacturer with responsibility for the entire performance evaluation studyof an in vitro diagnostic medical device2.2drop outspecimen or proband that had been selected for a performance evaluation study, but cannot beinvestigated as planned2.3evaluation plandescription of a planned performance evaluation study2.4evaluation reportdescription of and conclusions from a performance evaluation study2.5investigatorperson responsible for the execution of the performance evaluation at a certain location2.6lay personindividual who does not have specific medical education[EN ISO 9000:2000, 3.8.5]

The term “validated” is used to designate the corresponding status.NOTE 2
The use conditions for validation can be real or simulated.[ISO 9000, 3.8.5]3
General requirements for the performance evaluation3.1
Responsibilities and resourcesThe manufacturer takes the responsibility for the initiation and/or the conduct of a performanceevaluation study. He shall define the responsibility and the interrelation of all personnel who manageand conduct the performance evaluation of IVD MDs, particularly for personnel who need theorganisational freedom and authority to

DocumentationThe documentation of the performance evaluation study shall contain the files relating to clauses 3 to7 of this standard and shall be part of the technical documentation of the IVD MD.3.3
Final assessment and reviewThe co-ordinator shall assess and document which performance claims are met, state whether claimsare not met and give recommendations for corrective actions, where necessary.The responsible management of the manufacturer shall make sure that the results of the performanceevaluation study and the recommendations for corrective actions are carefully considered and properlydocumented before issuing a declaration of conformity.4
Organisation of a performance evaluation study4.1
PreconditionsBefore starting a performance evaluation study it shall be ensured by the co-ordinator thata) the performance claims of the IVD MD which are the subject of the study are specified;b) the IVD MD has been manufactured under controlled production processes and conditions;c) the IVD MD to be evaluated meets the quality control release specifications;d) a sufficient number of samples of the IVD MD can be provided during the entire period of theperformance evaluation study;e) all legal requirements for performance evaluation studies are met;f) the investigator(s) is (are) adequately skilled and trained to conduct the study and the necessaryresources are available.4.2
Evaluation planThe evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope ofthe evaluation, the structure and organization of the study and the number of devices concerned.Defining the objective of the study, the co-ordinator shall have assessed which performance claimsare already verified by data or scientific literature.
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