EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

Klinische Prüfung von Medizinprodukten an Menschen - Teil 2: Klinische Prüfpläne (ISO 14155-2:2003)

Dieser Teil von EN ISO 14155 legt Anforderungen für die Erarbeitung von Prüfplänen (CIP) für die klinische Prüfung von Medizinprodukten fest. Die Erarbeitung eines CIP in Übereinstimmung mit den Anforderungen dieser Norm und dessen Befolgung wird die wissenschaftliche Gültigkeit einer klinischen Prüfung und die Reproduzierbarkeit ihrer Ergebnisse verbessern helfen.
Diese Norm gilt nicht für Medizinprodukte für die In-vitro-Diagnostik.

Investigation clinique des dispositifs médicaux pour sujets humains - Partie 2: Plans d'investigation clinique (ISO 14155-2:2003)

Klinične raziskave medicinskih pripomočkov za ljudi - 2. del: Načrti kliničnih raziskav (ISO 14155-2:2003)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2009
• Withdrawal Date: 31-Jan-2011
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 258 - Clinical investigation of medical devices
• Drafting Committee: CEN/TC 258/WG 2 - Clinical investigation plans
• 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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14155-2:2009 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Relations

• Replaces: EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• Effective Date: 18-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14155-2:2009
01-november-2009
1DGRPHãþD
SIST EN ISO 14155-2:2003
.OLQLþQHUD]LVNDYHPHGLFLQVNLKSULSRPRþNRY]DOMXGLGHO1DþUWLNOLQLþQLK
UD]LVNDY,62
Clinical investigation of medical devices for human subjects - Part 2: Clinical
investigation plans (ISO 14155-2:2003)
Klinische Prüfung von Medizinprodukten an Menschen - Teil 2: Klinische Prüfpläne (ISO
14155-2:2003)
Investigation clinique des dispositifs médicaux sur les sujets humains - Partie 2: Plan
d'investigation clinique (ISO 14155-2:2003)
Ta slovenski standard je istoveten z: EN ISO 14155-2:2009
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14155-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14155-2:2009

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SIST EN ISO 14155-2:2009
EUROPEAN STANDARD
EN ISO 14155-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2009
ICS 11.100.20 Supersedes EN ISO 14155-2:2003
English Version
Clinical investigation of medical devices for human subjects -
Part 2: Clinical investigation plans (ISO 14155-2:2003)
Investigation clinique des dispositifs médicaux pour sujets Klinische Prüfung von Medizinprodukten an Menschen -
humains - Partie 2: Plans d'investigation clinique (ISO Teil 2: Klinische Prüfpläne (ISO 14155-2:2003)
14155-2:2003)
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 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 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 Management Centre has the same 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155-2:2009: E
worldwide for CEN national Members.

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SIST EN ISO 14155-2:2009
EN ISO 14155-2:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .5

2

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SIST EN ISO 14155-2:2009
EN ISO 14155-2:2009 (E)
Foreword
The text of ISO 14155-2:2003 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 14155-2:2009 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 14155-2:2003.
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: Aus
...