EN ISO 14155:2011
(Main)Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011)
Diese Internationale Norm legt die gute klinische Praxis für die Gestaltung, die Durchführung, Aufzeichnung
und Dokumentation klinischer Prüfungen, die an menschlichen Versuchspersonen durchgeführt werden, fest,
um die Sicherheit und Leistungsfähigkeit von Medizinprodukten für regulatorische Zwecke zu bewerten.
Die in der vorliegenden Internationalen Norm dargestellten Grundsätze treffen auf alle anderen klinische
Prüfungen zu und sollten so weit wie möglich, unter Berücksichtigung der Art der klinischen Prüfung und der
Anforderungen der nationalen Bestimmungen, eingehalten werden.
Diese Internationale Norm legt allgemeine Anforderungen fest, mit denen Folgendes erreicht werden soll
⎯ der Schutz der Rechte, Sicherheit und des Wohlergehens der beteiligten Versuchspersonen,
⎯ die Sicherstellung der wissenschaftlich korrekten Durchführung der klinischen Prüfung und der
Glaubwürdigkeit der Ergebnisse der klinischen Prüfung,
⎯ die Festlegung der Verantwortlichkeiten des Sponsors und Prüfungsleiters,
⎯ die Unterstützung der Arbeit von Sponsoren, Prüfern, Ethikkommissionen, gesetzlich Aufsichtsbehörden
und der am Konformitätsbewertungsverfahren für Medizinprodukte beteiligten Institutionen.
Sie gilt nicht für Medizinprodukten für die In vitro Diagnostik.
ANMERKUNG Von ISO/TC 194 erarbeitete Normen sind für die Anwendung auf Medizinprodukte vorgesehen.
Anwender dieser Internationalen Norm haben zu berücksichtigen, ob weitere Normen und/oder Anforderungen auf das zu
betrachtende Prüfprodukt ebenfalls angewendet werden können.
Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques (ISO 14155:2011)
L'ISO 14155:2011 traite les bonnes pratiques cliniques pour la conception, la conduite, l'enregistrement et l'établissement des rapports des investigations cliniques menées sur des sujets humains en vue d'évaluer la sécurité ou les performances des dispositifs médicaux à des fins réglementaires.
Les principes définis dans l'ISO 14155:2011 s'appliquent également aux autres investigations cliniques et il convient de les suivre dans la mesure du possible, en prenant en compte la nature de l'investigation et les exigences imposées par les réglementations nationales.
L'ISO 14155:2011 fixe les exigences générales pour protéger les droits, la sécurité et le bien-être des sujets humains, assurer la conduite scientifique de l'investigation clinique et la crédibilité des résultats de l'investigation, définir les responsabilités du promoteur et de l'investigateur principal et aider les promoteurs, les investigateurs, les comités d'éthique, les autorités réglementaires, et les autres organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux.
L'ISO 14155:2011 ne s'applique pas aux dispositifs médicaux de diagnostic in vitro.
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse (ISO 14155:2011)
Ta mednarodni standard naslavlja dobro klinično prakso za načrtovanje, izvajanje, beleženje in poročanje o kliničnih preiskavah, izvedenih na ljudeh, za ocenjevanje varnosti ali delovanja medicinskih pripomočkov za potrebe regulacije.
Načela, določena v tem mednarodnem standardu, prav tako veljajo za vse preostale klinične raziskave in jim je treba slediti, kolikor je mogoče, upoštevajoč naravo kliničnih raziskav in zahteve državnih predpisov.
Ta mednarodni standard določa splošne zahteve za:
– zaščito pravic, varnost in dobro počutje ljudi,
– zagotavljanje znanstvenega izvajanja klinične raziskave in verodostojnost rezultatov klinične raziskave,
– opredelitev odgovornosti sponzorja in vodilnega raziskovalca ter
– pomoč sponzorjem, preiskovalcem, etičnim odborom, regulativnim organom in drugim organom, ki so vključeni v ugotavljanje skladnosti medicinskih pripomočkov.
Ne velja za diagnostične medicinske pripomočke in vitro.
OPOMBA Standardi, ki jih je razvil ISO/TC, so namenjeni uporabi pri medicinskih pripomočkih. Uporabniki tega mednarodnega standarda bodo morali upoštevati, ali drugi standardi in/ali zahteve prav tako veljajo za raziskovalne naprave, ki jih obravnavajo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2011
1DGRPHãþD
SIST EN ISO 14155-1:2009
SIST EN ISO 14155-2:2009
.OLQLþQHUD]LVNDYHPHGLFLQVNLKSULSRPRþNRY]DOMXGL'REUHNOLQLþQHSUDNVH ,62
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO
14155:2011)
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO
14155:2011)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques
cliniques (ISO 14155:2011)
Ta slovenski standard je istoveten z: EN ISO 14155:2011
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 14155
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2011
ICS 11.100.20 Supersedes EN ISO 14155-1:2009, EN ISO 14155-2:2009
English Version
Clinical investigation of medical devices for human subjects -
Good clinical practice (ISO 14155:2011)
Investigation clinique des dispositifs médicaux pour sujets Klinische Prüfung von Medizinprodukten an Menschen -
humains - Bonnes pratiques cliniques (ISO 14155:2011) Gute klinische Praxis (ISO 14155:2011)
This European Standard was approved by CEN on 10 December 2010.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA .4
Annex ZB .5
Foreword
This document (EN ISO 14155:2011) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation of medical devices" in collaboration with 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 August 2011, and conflicting national standards shall be withdrawn at
the latest by August 2011.
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 14155-1:2009 and EN ISO 14155-2:2009.
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(s).
For relationship with EU Directives, see informative Annexes 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, Croatia, 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 14155:2011 has been approved by CEN as a EN ISO 14155:2011 without any modification.
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 Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard 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.
NOTE This standard is specifically intended to provide a means for getting presumption of conformity to the part of
Essential Requirement 6a that refers to clinical investigations, as developed in Annex X, 2nd part (2.1 to 2.3.7) of the
above-mentioned directive.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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 93/42/EEC on Medical Devices
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard 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.
NOTE This standard is specifically intended to provide a means for getting presumption of conformity to the part of
Essential Requirement 5. that refers to clinical investigations, as developed in Annex 7, 2nd part (2.1 to 2.3.7) of the above
mentioned directive.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 14155
Second edition
2011-02-01
Clinical investigation of medical devices
for human subjects — Good clinical
practice
Investigation clinique des dispositifs médicaux pour sujets humains —
Bonnes pratiques cliniques
Reference number
ISO 14155:2011(E)
©
ISO 2011
ISO 14155:2011(E)
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ISO 14155:2011(E)
Contents Page
Foreword .v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Ethical considerations .7
4.1 General .7
4.2 Improper influence or inducement .8
4.3 Compensation and additional health care.8
4.4 Responsibilities.8
4.5 Communication with the ethics committee (EC).8
4.5.1 General .8
4.5.2 Initial EC submission .8
4.5.3 Information to be obtained from the EC.9
4.5.4 Continuing communication with the EC .9
4.5.5 Continuing information to be obtained from the EC .9
4.6 Vulnerable populations.9
4.7 Informed consent .10
4.7.1 General .10
4.7.2 Process of obtaining informed consent.10
4.7.3 Special circumstances for informed consent .10
4.7.4 Information to be provided to the subject .11
4.7.5 Informed consent signature .13
4.7.6 New information .13
5 Clinical investigation planning .14
5.1 General .14
5.2 Risk evaluation .14
5.3 Justification for the design of the clinical investigation.14
5.4 Clinical investigation plan (CIP).14
5.5 Investigator's brochure (IB).15
5.6 Case report forms (CRFs).15
5.7 Monitoring plan.15
5.8 Investigation site selection .15
5.9 Agreement(s) .
...
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