EN ISO 14155-1:2009

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
ISO 14155-1:2002
specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

Klinische Prüfung von Medizinprodukten an Menschen - Teil 1: Allgemeine Anforderungen (ISO 14155-1:2003)

Diese Internationale Norm legt Verfahren für die Durchführung klinischer Prüfungen von Medizinprodukten fest. Sie legt allgemeine Anforderungen fest, mit denen Folgendes erreicht werden soll:
-   der Schutz der beteiligten Versuchspersonen;
-   die Sicherstellung der wissenschaftlich korrekten Durchführung der klinischen Prüfung;
-   die Unterstützung von Sponsoren, Monitoren, Prüfern, Ethikkommissionen, Behörden und der am Konformitätsbewertungsverfahren für Medizinprodukte beteiligten Institutionen.
Dieser Teil von ISO 14155
a)   gilt für alle klinischen Prüfungen von Medizinprodukten, deren klinische Leistungsfähigkeit und Sicherheit an menschlichen Versuchspersonen bewertet wird,
b)   legt Anforderungen für die Durchführung einer klinischen Prüfung fest, so dass die Leistung des Medizinprodukts während der klinischen Prüfung, die die normale klinische Anwendung nachahmen soll, nachgewiesen wird, deckt unerwünschte Ereignisse unter normalen klinischen Anwendungsbedingungen auf und ermöglicht eine Bewertung der vertretbaren Risiken, die mit der vorgesehenen Leistung des Medizinprodukts verbunden sind,
c)   legt Anforderungen für die Organisation, die Durchführung, Überwachung, Datenerfassung und die Dokumentation der klinischen Prüfung eines Medizinprodukts fest.
Dieser Teil von ISO 14155 gilt nicht für Medizinprodukte für die In-vitro-Diagnostik.

Investigation clinique des dispositifs médicaux pour sujets humains - Partie 1: Exigences générales (ISO 14155-1:2003)

L'ISO 14155-1:2003 définit les procédures utilisables pour la conduite et l'exécution des investigations cliniques portant sur les dispositifs médicaux. Elle fixe les exigences générales pour
protéger les sujets humains,assurer la conduite scientifique des investigations cliniques,aider les promoteurs, les moniteurs, les investigateurs cliniques, les comités d'éthique, les autorités de réglementation et les organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux.
L'ISO 14155-1:2003
définit les exigences pour la conduite d'une investigation clinique afin de démontrer la performance d'un dispositif médical pendant l'utilisation clinique reflétant l'utilisation clinique normale, de révéler tout événement indésirable dans des conditions normales d'utilisation et de permettre l'évaluation des risques acceptables au regard des performances assignées au dispositif médical,définit les exigences relatives à l'organisation, la conduite, le contrôle, le recueil des données et la documentation des investigations cliniques portant sur un dispositif médical,est relative à toute(s) investigation(s) clinique(s) portant sur des dispositifs médicaux dont la performance clinique et la sécurité sont évaluées sur des sujets humains.
L'ISO 14155-1:2003 n'est pas applicable aux dispositifs médicaux de diagnostic in vitro.

Klinične raziskave medicinskih pripomočkov za ljudi - 1. del: Splošne zahteve (ISO 14155-1:2003)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2009
• Withdrawal Date: 31-Jan-2011
• ICS: 01.040.01 - Generalities. Terminology. Standardization. Documentation (Vocabularies)
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 258 - Clinical investigation of medical devices
• Drafting Committee: CEN/TC 258 - Clinical investigation of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Feb-2011
• Completion Date: 01-Feb-2011
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 14155-1:2009 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

Relations

• Replaces: EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
• Effective Date: 18-Jul-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Klinische Prüfung von Medizinprodukten an Menschen - Teil 1: Allgemeine Anforderungen (ISO 14155-1:2003)Investigation clinique des dispositifs médicaux pour sujets humains - Partie 1: Exigences générales (ISO 14155-1:2003)Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:EN ISO 14155-1:2009SIST EN ISO 14155-1:2009en01-december-2009SIST EN ISO 14155-1:2009SLOVENSKI
STANDARDSIST EN ISO 14155-1:20031DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14155-1July 2009ICS 11.100.20Supersedes EN ISO 14155-1:2003
English VersionClinical investigation of medical devices for human subjects -Part 1: General requirements (ISO 14155-1:2003)Investigation clinique des dispositifs médicaux pour sujetshumains - Partie 1: Exigences générales (ISO 14155-1:2003)Klinische Prüfung von Medizinprodukten an Menschen -Teil 1: Allgemeine Anforderungen (ISO 14155-1:2003)This European Standard was approved by CEN on 27 June 2009.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 CEN 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 CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14155-1:2009: ESIST EN ISO 14155-1:2009

Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices .4Annex ZB (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices .5 SIST EN ISO 14155-1:2009

Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/NotesA.2.5 Annex X:
1.1.1 This requirement is also addressed in 4.5.1 of EN 14155-2:2003 11 Annex X: 1.1.2 This requirement is also addressed in 4.5.3 of EN 14155-2:2003
Annex X: 1.1.a) This requirement is not addressed in this standard 7 Annex X: 1.1.b) This requirement is partly addressed in this standard
Annex X: 1.1.c) This requirement is not addressed in this standard
Annex X: 1.1.d) This requirement is not addressed in this standard 5 Annex X: 2.2
6.3 Annex X: 2.3.1 Entire EN 14155-2 6.4 Annex X: 2.3.2 This requirement is also addressed in 4.7 of EN 14155-2:2003 6.4 Annex X: 2.3.3 This requirement is also addressed in 4.7 of EN 14155-2:2003
Annex X: 2.3.4 This requirement is not addressed in this standard
This requirement is addressed in 4.5.4 of EN 14155-2:2003 8.2 i) Annex X: 2.3.5 This requirement is also addressed in 4.11 of EN 14155-2:2003 10.2 a) Annex X: 2.3.6
11.2 Annex X: 2.3.7
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZB confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB — Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/NotesA.2.5 Annex 7:
1.1.1 This requirement is also addressed in 4.5.1 of EN 14155-2:2003 11 Annex 7: 1.1.2 This requirement is also addressed in 4.5.3 of EN 14155-2:2003 A.2.5 Annex 7: 1.2
7 Annex 7: 1.3
Annex 7: 1.4 This requirement is not addressed in this standard
Annex 7: 1.5 This requirement is not addressed in this standard 6.3 Annex 7: 2.3.1 Entire EN 14155 6.4 Annex 7: 2.3.2 This requirement is also addressed in 4.7 of EN 14155-2:2003 6.4 Annex 7: 2.3.3 This requirement is also addressed in 4.7 of EN 14155-2:2003 6.5 Annex 7: 1.6
Annex 7: 2.3.4 This requirement is not addressed in this standard
This requirement is addressed in 4.5.4 of EN 14155-2:2003 8.2 i) Annex 7: 2.3.5 This requirement is also addressed in 4.11 of EN 14155-2:2003 10.2 a) Annex 7: 2.3.6
11.2 Annex 7: 2.3.7
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 14155-1:2009

Reference numberISO 14155-1:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO14155-1First edition2003-02-15Clinical investigation of medical devices for human subjects —
Part 1: General requirements Investigation clinique des dispositifs médicaux pour sujets humains —
Partie 1: Exigences générales
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ii © ISO 2003 — All rights reserved
ISO 14155-1:2003(E) © ISO 2003 — All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Justification for a clinical investigation.5 5 Ethical considerations.5 5.1 Declaration of Helsinki.5 5.2 Improper influence or inducement.5 5.3 Compensation and additional health care.5 5.4 Responsibilities.5 6 General requirements.5 6.1 Formal agreement(s).5 6.2 Qualifications.5 6.3 Clinical investigation plan.6 6.4 Design of the clinical investigation.6 6.5 Confidentiality.6 6.6 Start of clinical investigation.6 6.7 Informed consent.6 6.8 Suspension or early termination of the clinical investigation.8 6.9 Document and data control.8 6.10 Accounting for subjects.9 6.11 Access to preclinical and clinical information.9 6.12 Auditing.9 7 Documentation.9 7.1 General.9 7.2 Clinical investigator's brochure.
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