SIST EN ISO 14155-1:2003

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)Investigation clinique des dispositifs médicaux pour sujets humains - Partie 1: Exigences générales (ISO 14155-1:2003)Klinische Prüfung von Medizinprodukten an Menschen - Teil 1: Allgemeine Anforderungen (ISO 14155-1:2003)Ta slovenski standard je istoveten z:EN ISO 14155-1:2003SIST EN ISO 14155-1:2003en11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:SIST EN 540:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN ISO 14155-1:200301-september-2003

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14155-1February 2003ICS 11.100Supersedes EN 540:1993English 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 7 February 2003.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,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovak Republic, Spain, Sweden, Switzerland andUnited Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14155-1:2003 E

2003-04-30ForewordThis document (EN ISO 14155-1:2003) has been prepared by Technical Committee ISO/TC 194"Biological evaluation of medical devices" in collaboration with Technical Committee CEN/TC258 "Clinical investigation of medical devices", the secretariat of which is held by AFNOR.This European Standard shall be given the status of a national standard, either by publication ofan identical text or by endorsement, at the latest by August 2003, and conflicting nationalstandards shall be withdrawn at the latest by August 2003.This document supersedes EN 540:1993.This document has been prepared under a mandate given to CEN by the European Commissionand the European Free Trade Association, and supports essential requirements of EUDirective(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of thisdocument.According to the CEN/CENELEC Internal Regulations, the national standards organizations ofthe following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland andthe United Kingdom.Endorsement noticeThe text of ISO 14155-1:2003 has been approved by CEN as EN ISO 14155-1:2003 without anymodifications.

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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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.9 7.3 Other documents.10 8 Sponsor.10 8.1 General.10 8.2 Responsibilities of sponsor.10 9 Monitor.11 9.1 Responsibilities of monitor.11 10 Clinical investigator.12 10.1 General.12 10.2 Qualification of clinical investigator.12 10.3 Responsibilities of clinical investigator.12 11 Final report.14 11.1 Presentation of results.14 11.2 Contents of the final report.14

ISO 14155-1:2003(E) iv © ISO 2003 — All rights reserved Annex A (informative)
Suggested procedure for literature review.15 Annex B (informative)
Information for the ethics committees.17 Annex C (informative)
Final reports of clinical investigations with medical devices.18 Bibliography.21

ISO 14155-1:2003(E) © ISO 2003 — All rights reserved v 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 14155-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This first edition of ISO 14155-1, together with ISO 14155-2, cancels and replace ISO 14155:1996, which has been technically revised. ISO 14155 consists of the following parts, under the general title Clinical investigation of medical devices for human subjects:  Part 1: General requirements  Part 2: Clinical investigation plans

ISO 14155-1:2003(E) vi © ISO 2003 — All rights reserved Introduction This part of ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfil the technical aspects of the various national, regional a
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