SIST EN ISO 14155-1:2009
(Main)Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
This part of ISO 14155 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. This part of ISO 14155 a) 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, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 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)
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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
SIST EN ISO 14155-1:2009
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
EN ISO 14155-1:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
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
EN ISO 14155-1:2009 (E) 3 Foreword The text of ISO 14155-1:2003 has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14155-1:2009 by Technical Committee CEN/TC 258 “Clinical investigation of 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 January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. 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 14155-1:2003. 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 EC Directives. For relationship with EC Directives, see informative Annex ZA and ZB, which are an integral part of this document. 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, 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 the United Kingdom. Endorsement notice The text of ISO 14155-1:2003 has been approved by CEN as a EN ISO 14155-1:2009 without any modification.
SIST EN ISO 14155-1:2009
EN ISO 14155-1:2009 (E) 4 Annex ZA (informative)
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.
SIST EN ISO 14155-1:2009
EN ISO 14155-1:2009 (E) 5 Annex ZB (informative)
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
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
SIST EN ISO 14155-1:2009
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SIST EN ISO 14155-1:2009
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 SIST EN ISO 14155-1:2009
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
SIST EN ISO 14155-1:2009
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 SIST EN ISO 14155-1:2009
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 and international regulatory requirements. As the legal regulatory requirements presently differ throughout the world, regulatory specifics have been excluded from the scope of this part of ISO 14155. They are part of national or regional legislative texts and can be referenced in the national or regional forewords, as appropriate.
SIST EN ISO 14155-1:2009
INTERNATIONAL STANDARD ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 1 Clinical investigation of medical devices for human subjects — Part 1: General requirements 1 Scope This part of ISO 14155 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. This part of ISO 14155 a) 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, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans SIST EN ISO 14155-1:2009
ISO 14155-1:2003(E) 2 © ISO 2003 — All rights reserved 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 adverse device effect any untoward and unintended response to a medical device NOTE 1 This definition includes any event resulting from insufficiencies or inadequacies in the instructions for use or the deployment of the device. NOTE 2 This definition includes any event that is a result of a user error. 3.2 adverse event any untoward medical occurrence in a subject NOTE This definition does not imply that there is a relationship between the adverse event and the device under investigation. 3.3 case report form document designed to record all information to be reported to the sponsor on each subject as required by the clinical investigation plan 3.4 clinical investigation any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device 3.5 clinical investigation plan CIP document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation NOTE The word “protocol” is often used synonymously with the term “clinical investigation plan”. However, it has many different meanings, some not related to clinical investigations, and these may differ from country to country. Therefore, it is not used in this part of ISO 14155. 3.6 clinical investigator individual and/or institution responsible for the conduct of a clinical investigation who and/or which takes the clinical responsibility for the well-being of the subjects involved NOTE Whether this is an individual or an institutional responsibility may depend on national legislation. 3.7 clinical investigator's brochure compilation of the clinical and non-clinical information on the device(s) under investigation, that is relevant to the investigation in human subjects 3.8 clinical performance behaviour of a specific medical device and/or its performance in relation to its intended use when correctly applied to appropriate subjects 3.9 coordinating clinical investigator clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation SIST EN ISO 14155-1:2009
ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 3 3.10 ethics committee independent and properly constituted competent body whose responsibility is to ensure that the safety, well-being and human rights of the subjects participating in a clinical investigation are protected NOTE For the purposes of this part of ISO 14155, “ethics committee” is synonymous with “research ethics committee” or “institutional review board”. The regulatory requirements pertaining to ethics committees or similar institutions may differ from country to country. 3.11 final report description, results and evaluation of the clinical investigation after its completion 3.12 informed consent legally effective, documented confirmation of a subject's (or his/her legal guardian or representative) voluntary agreement to participate in a particular clinical investigation after information has been given to the subject on all aspects of the clinical investigation that are relevant to the subject's decision to participate 3.13 investigation centre investigation site institution or site where the clinical investigation is carried out 3.14 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTE The term “medical device” is usually defined by national law. In order to inform the user of this part of ISO 14155, the definition from reference [1] is listed (see Bibliography). More information is given in reference [3]. 3.15 monitor individual appointed by the sponsor responsible for assessing the investigator's compliance with the clinical investigation plan and for performing source-data verification NOTE The monitor is also responsible for reporting to the sponsor on the progress of the clinical investigation, including the compliance of the investigators. 3.16 multicentre investigation clinical investigation which is conducted according to a single clinical investigation plan and which takes place at two or more sites 3.17 principal clinical investigator clinical investigator responsible for the organization of the clinical investigation at one site SIST EN ISO 14155-1:2009
ISO 14155-1:2003(E) 4 © ISO 2003 — All rights reserved 3.18 serious adverse device effect adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made or if circumstances had been less opportune 3.19 serious adverse event adverse event that a) led to a death, b) led to a serious deterioration in the health of the subject that 1) resulted in a life-threatening illness or injury, 2) resulted in a permanent impairment of a body structure or a body function, 3) required in-patient hospitalization or prolongation of existing hospitalization, 4) resulted in medical or surgical intervention to prevent permanent impairment to body structure or a body function. c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 3.20 source data all information in original and identified records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation 3.21 source documents original documents, data and records NOTE This may be for example, hospital records, laboratory notes, pharmacy dispensing records, copies or transcriptions certified after verification as being accurate copies, photographic negatives, radiographs, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical investigation. 3.22 sponsor individual or organization who or which takes responsibility for the initiation and/or implementation of a clinical investigation NOTE 1 For the purposes of this part of ISO 14155 the word “sponsor” is synonymous with the word “promoter”. NOTE 2 When a clinical investigator independently initiates, implements and takes full responsibility for the clinical investigation, the clinical investigator also assumes the role of the sponsor. 3.23 subject individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control SIST EN ISO 14155-1:2009
ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 5 4 Justification for a clinical investigation In order to determine the justification and optimal design for a clinical investigation, an objective review of published and available unpublished medical and scientific data and information shall be conducted and documented. NOTE 1 Guidance for such a literature review is given in Annex A. The decision to embark upon a clinical investigation of a medical device requires inter alia the residual risks to be balanced against the anticipated benefits of the clinical investigation. NOTE 2 For further information, see ISO 14971[6]. 5 Ethical considerations 5.1 Declaration of Helsinki
The rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki. This shall be understood, obse
...
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)11.100.20Biological evaluation of medical devices11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:FprEN ISO 14155-1kSIST FprEN ISO 14155-1:2009enkSIST FprEN ISO 14155-1:2009SLOVENSKI
STANDARD
kSIST FprEN ISO 14155-1:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTFprEN ISO 14155-1February 2009ICS 11.100.20Will supersede 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 draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 258.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.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. FprEN ISO 14155-1:2009: EkSIST FprEN ISO 14155-1:2009
FprEN ISO 14155-1:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
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 kSIST FprEN ISO 14155-1:2009
FprEN ISO 14155-1:2009 (E) 3 Foreword The text of ISO 14155-1:2003 has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 14155-1:2009 by Technical Committee CEN/TC 258 “Clinical investigation of medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 14155-1:2003. 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 EC Directives. For relationship with EC Directives, see informative Annex ZA and ZB, which are an integral part of this document. Endorsement notice The text of ISO 14155-1:2003 has been approved by CEN as a FprEN ISO 14155-1:2009 without any modification. kSIST FprEN ISO 14155-1:2009
FprEN ISO 14155-1:2009 (E) 4 Annex ZA (informative)
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.
kSIST FprEN ISO 14155-1:2009
FprEN ISO 14155-1:2009 (E) 5 Annex ZB (informative)
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. kSIST FprEN ISO 14155-1:2009
kSIST FprEN 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
kSIST FprEN ISO 14155-1:2009
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kSIST FprEN ISO 14155-1:2009
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 kSIST FprEN ISO 14155-1:2009
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
kSIST FprEN ISO 14155-1:2009
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 kSIST FprEN ISO 14155-1:2009
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 and international regulatory requirements. As the legal regulatory requirements presently differ throughout the world, regulatory specifics have been excluded from the scope of this part of ISO 14155. They are part of national or regional legislative texts and can be referenced in the national or regional forewords, as appropriate.
kSIST FprEN ISO 14155-1:2009
INTERNATIONAL STANDARD ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 1 Clinical investigation of medical devices for human subjects — Part 1: General requirements 1 Scope This part of ISO 14155 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. This part of ISO 14155 a) 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, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans kSIST FprEN ISO 14155-1:2009
ISO 14155-1:2003(E) 2 © ISO 2003 — All rights reserved 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 adverse device effect any untoward and unintended response to a medical device NOTE 1 This definition includes any event resulting from insufficiencies or inadequacies in the instructions for use or the deployment of the device. NOTE 2 This definition includes any event that is a result of a user error. 3.2 adverse event any untoward medical occurrence in a subject NOTE This definition does not imply that there is a relationship between the adverse event and the device under investigation. 3.3 case report form document designed to record all information to be reported to the sponsor on each subject as required by the clinical investigation plan 3.4 clinical investigation any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device 3.5 clinical investigation plan CIP document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation NOTE The word “protocol” is often used synonymously with the term “clinical investigation plan”. However, it has many different meanings, some not related to clinical investigations, and these may differ from country to country. Therefore, it is not used in this part of ISO 14155. 3.6 clinical investigator individual and/or institution responsible for the conduct of a clinical investigation who and/or which takes the clinical responsibility for the well-being of the subjects involved NOTE Whether this is an individual or an institutional responsibility may depend on national legislation. 3.7 clinical investigator's brochure compilation of the clinical and non-clinical information on the device(s) under investigation, that is relevant to the investigation in human subjects 3.8 clinical performance behaviour of a specific medical device and/or its performance in relation to its intended use when correctly applied to appropriate subjects 3.9 coordinating clinical investigator clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation kSIST FprEN ISO 14155-1:2009
ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 3 3.10 ethics committee independent and properly constituted competent body whose responsibility is to ensure that the safety, well-being and human rights of the subjects participating in a clinical investigation are protected NOTE For the purposes of this part of ISO 14155, “ethics committee” is synonymous with “research ethics committee” or “institutional review board”. The regulatory requirements pertaining to ethics committees or similar institutions may differ from country to country. 3.11 final report description, results and evaluation of the clinical investigation after its completion 3.12 informed consent legally effective, documented confirmation of a subject's (or his/her legal guardian or representative) voluntary agreement to participate in a particular clinical investigation after information has been given to the subject on all aspects of the clinical investigation that are relevant to the subject's decision to participate 3.13 investigation centre investigation site institution or site where the clinical investigation is carried out 3.14 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTE The term “medical device” is usually defined by national law. In order to inform the user of this part of ISO 14155, the definition from reference [1] is listed (see Bibliography). More information is given in reference [3]. 3.15 monitor individual appointed by the sponsor responsible for assessing the investigator's compliance with the clinical investigation plan and for performing source-data verification NOTE The monitor is also responsible for reporting to the sponsor on the progress of the clinical investigation, including the compliance of the investigators. 3.16 multicentre investigation clinical investigation which is conducted according to a single clinical investigation plan and which takes place at two or more sites 3.17 principal clinical investigator clinical investigator responsible for the organization of the clinical investigation at one site kSIST FprEN ISO 14155-1:2009
ISO 14155-1:2003(E) 4 © ISO 2003 — All rights reserved 3.18 serious adverse device effect adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made or if circumstances had been less opportune 3.19 serious adverse event adverse event that a) led to a death, b) led to a serious deterioration in the health of the subject that 1) resulted in a life-threatening illness or injury, 2) resulted in a permanent impairment of a body structure or a body function, 3) required in-patient hospitalization or prolongation of existing hospitalization, 4) resulted in medical or surgical intervention to prevent permanent impairment to body structure or a body function. c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 3.20 source data all information in original and identified records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation 3.21 source documents original documents, data and records NOTE This may be for example, hospital records, laboratory notes, pharmacy dispensing records, copies or transcriptions certified after verification as being accurate copies, photographic negatives, radiographs, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical investigation. 3.22 sponsor individual or organization who or which takes responsibility for the initiation and/or implementation of a clinical investigation NOTE 1 For the purposes of this part of ISO 14155 the word “sponsor” is synonymous with the word “promoter”. NOTE 2 When a clinical investigator independently initiates, implements and takes full responsibility for the clinical investigation, the clinical investigator also assumes the role of the sponsor. 3.23 subject individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control kSIST FprEN ISO 14155-1:2009
ISO 14155-1:2003(E) © ISO 2003 — All rights reserved 5 4 Justification for a clinical investigation In order to determine the justification and optimal design for a clinical investigation, an objective review of published and available unpublished medical and scientific data and information shall be conducted and documented. NOTE 1 Guidance for such a literature review is given in Annex A. The decision to embark upon a clinical investigation of a medical device requires inter alia the residual risks to be balanced against the anticipated benefits of the clinical investigation. NOTE 2 For further information, see ISO 14971[6]. 5 Ethical considerations 5.1 Declaration of Helsinki
The rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki. This shall be understood, observed and applied at every step in the clinical investigation. 5.2 Improper influence or inducement The sponsor and the clinical investigator(s) shall avoid improper influence or inducement of the subject, monitor, the clinical investigator(s) or other parties participating in or contributing to the clinical investigation. 5.3 Compensation and additional health care The sponsor shall state what provision will be made for compensation of subjects in the event of injury arising from participation in the clinical investigation and this shall be docume
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