SIST EN ISO 14155-2:2009

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

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.

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 sur les sujets humains - Partie 2: Plan 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• Status: Withdrawn
• Public Enquiry End Date: 14-May-2009
• Publication Date: 12-Oct-2009
• Withdrawal Date: 24-Feb-2011
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 24-Feb-2011
• Due Date: 19-Mar-2011
• Completion Date: 25-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: EN ISO 14155-2:2009 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Relations

• Replaced By: SIST EN ISO 14155:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• Effective Date: 01-Apr-2011
• Replaced By: SIST EN ISO 14155:2011 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
• Effective Date: 01-Nov-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: 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 14155-2:2003 has been approved by CEN as a EN ISO 14155-2:2009 without any
modification.
3

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SIST EN ISO 14155-2:2009
EN ISO 14155-2:2009 (E)
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 Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
4.5.1 Annex X: This requirement is also addressed
1.1.1 in A.2.5 of EN 14155-1:2003
4.5.3 Annex X: This requirement is also addressed
1.1.2 in 11 of EN 14155-1:2003
4.5.4 Annex X:
2.3.4
Annex X: This requirement is not addressed in
1.1.a) this standard
Annex X: This requirement is partly addressed
1.1 b) in Clause 7 of EN 14155-1:2003
Annex X: This requirement is not addressed in
1.1 c) this standard
Annex X: This requirement is not addressed in
1.1 d) this standard
Annex X: This requirement is addressed in
2.2 Clause 5 of EN 14155-1:2003
Entire document Annex X: This requirement is also addressed
2.3.1 in 6.3 of EN 14155-1:2003
4.7 Annex X: This requirement is also addressed
2.3.2 in 6.3 of EN 14155-1:2003
4.7 Annex X: This requirement is also addressed
2.3.3 in 6.3 of EN 14155-1:2003
4.11 Annex X: This requirement is also addressed
2.3.5 in 8.2 i) of EN 14155-1:2003
Annex X: This requirement is addressed in
2.3.6 10.2 a) of EN 14155-1:2003
Annex X: This requirement is addressed in
2.3.7 11.2 of EN 14155-1:2003

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

4

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SIST EN ISO 14155-2:2009
EN ISO 14155-2:2009 (E)
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 Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 90/385/EEC
4.5.1 Annex 7: This requirement is also addressed
1.1.1 in A.2.5 of EN 14155-1:2003
4.5.3 Annex 7: This requirement is also addressed
1.1.2 in Clause 11 of EN 14155-1:2003
4.5.4 Annex 7:
2.3.4
Annex 7: This requirement is addressed in
1.2 A.2.5 of EN 14155-1:2003
Annex 7: This requirement is addressed in
1.3 Clause 7 of EN 14155-1:2003
Annex 7: This requirement is not addressed in
1.4 this standard
Annex 7: This requirement is not addressed in
1.5 this standard
Annex 7: This requirement is addressed in 6.5
1.6 of EN 14155-1:2003
Entire document Annex 7: This requirement is also addressed
2.3.1 in 6.3 of EN 14155-1:2003
4.7 Annex 7: This requirement is also addressed
2.3.2 in 6.3 of EN 14155-1:2003
4.7 Annex 7: This requirement is also addressed
2.3.3 in 6.3 of EN 14155-1:2003
4.11 Annex 7: This requirement is also addressed
2.3.5 in 8.2 i) of EN 14155-1:2003
Annex 7: This requirement is addressed in
2.3.6 10.2 a) of EN 14155-1:2003
Annex 7: This requirement is addressed in
2.3.7 11.2 of EN 14155-1:2003

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5

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SIST EN ISO 14155-2:2009

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SIST EN ISO 14155-2:2009


INTERNATIONAL ISO
STANDARD 14155-2
First edition
2003-05-15

Clinical investigation of medical devices
for human subjects —
Part 2:
Clinical investigation plans
Investigation clinique des dispositifs médicaux pour sujets humains —
Partie 2: Plans d'investigation clinique




Reference number
ISO 14155-2:2003(E)
©
ISO 2003

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SIST EN ISO 14155-2:2009
ISO 14155-2:2003(E)
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ii © ISO 2003 – All rights reserved

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SIST EN ISO 14155-2:2009
ISO 14155-2:2003(E)
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 14155-2 was prepared by the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 194, Biological evaluation of medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International
Standard.".
This first edition, together with the first edition of ISO 14155-1, cancels and replaces 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
For the purposes of this part of ISO 14155, the CEN annex regarding fulfilment of European Council
Directives has been removed.
© ISO 2003 – All rights reserved iii

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SIST EN ISO 14155-2:2009
ISO 14155-2:2003(E)


Contents
Page
Foreword.v
Introduction .vi
1 Scope .1
2 Normative references .1
3 Terms and definitions.1
4 Requirements .2
4.1 General.2
4.2 Clinical Investigation Plan (CIP).2
4.3 General information.2
4.3.1 Identification of the clinical investigation plan.2
4.3.2 Clinical investigators, principal clinical investigator, co-ordinating clinical investigator,
investigation centres/site(s) .2
4.3.3 Sponsor.2
4.3.4 Monitoring arrangements.2
4.3.5 Data and quality management.2
4.3.6 An overall synopsis of the clinical investigation.3
4.3.7 Approval and agreement to the clinical investigation plan.3
4.4 Identification and description of the medical device to be investigated .3
4.5 Preliminary investigations and justification of the study.3
4.5.1 Literature review .3
4.5.2 Preclinical testing .3
4.5.3 Previous clinical experience.4
4.5.4 Device risk analysis and risk assessment .4
4.6 Objectives of the clinical investigation .4
4.7 Design of the clinical investigation.4
4.8 Statistical considerations .5
4.9 Deviations from the clinical investigation plan .6
4.10 Amendments to the clinical investigation plan .6
4.11 Adverse events and adverse device effects .6
4.12 Early termination or suspension of the investigation.6
4.13 Publication policy .6
4.14 Case Report Forms.7
Annex A (informative) Case Report Forms .8
Bibliography .9
iv © ISO 2003 – All rights reserved

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SIST EN ISO 14155-2:2009
ISO 14155-2:2003(E)


Foreword
This document (EN ISO 14155-2:2003) has been prepared by Technical Committee CEN /TC 258 "Clinical
investigation of medical devices", the secretariat of which is held by AFNOR, in collaboration with Technical
Committee ISO/TC 194 "Biological evaluation of medical devices".
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 November 2003, and conflicting national standards shall be withdrawn at the latest
by November 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 EU Directive(s).
Annex A is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
© ISO 2003 – All rights reserved v

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SIST EN ISO 14155-2:2009
ISO 14155-2:2003(E)


Introduction
This standard is the second part of EN ISO 14155 "Clinical investigation of medical devices for human subjects",
and should be read in conjunction with that standard.
The standard is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design and
conduct of clinical investigations. It is also intended to assist regulatory bodies and ethics committees in their roles
of reviewing Clinical Investigation Plans (CIP). The CIP is a framework within which appropriate experience, insight,
judgement, qualification and education need to be applied. The scientific rigour of a CIP can be verified and
possibly improved by an independent review of the CIP.
vi © ISO 2003 – All rights reserved

-----------
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski standard je istoveten z:FprEN ISO 14155-2kSIST FprEN ISO 14155-2:2009enkSIST FprEN ISO 14155-2:2009SLOVENSKI
STANDARD



kSIST FprEN ISO 14155-2:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTFprEN ISO 14155-2February 2009ICS 11.100.20Will supersede EN ISO 14155-2:2003
English VersionClinical investigation of medical devices for human subjects -Part 2: Clinical investigation plans (ISO 14155-2:2003)Investigation clinique des dispositifs médicaux sur lessujets humains - Partie 2: Plan d'investigation clinique (ISO14155-2:2003)Klinische Prüfung von Medizinprodukten an Menschen -Teil 2: Klinische Prüfpläne (ISO 14155-2:2003)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 14155-2:2009: EkSIST FprEN ISO 14155-2:2009



FprEN ISO 14155-2:2009 (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 14155-2:2009



FprEN ISO 14155-2:2009 (E) 3 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 FprEN ISO 14155-2:2009 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 14155-2:2003. 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. Endorsement notice The text of ISO 14155-2:2003 has been approved by CEN as a FprEN ISO 14155-2:2009 without any modification. kSIST FprEN ISO 14155-2:2009



FprEN ISO 14155-2:2009 (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/Notes4.5.1 Annex X:
1.1.1 This requirement is also addressed in A.2.5 of EN 14155-1:2003 4.5.3
Annex X: 1.1.2 This requirement is also addressed in 11 of EN 14155-1:2003 4.5.4 Annex X: 2.3.4
Annex X: 1.1.a) This requirement is not addressed in this standard
Annex X: 1.1 b) This requirement is partly addressed in Clause 7 of EN 14155-1:2003
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
Annex X: 2.2 This requirement is addressed in Clause 5 of EN 14155-1:2003 Entire document Annex X: 2.3.1 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.7 Annex X: 2.3.2 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.7 Annex X: 2.3.3 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.11 Annex X: 2.3.5 This requirement is also addressed in 8.2 i) of EN 14155-1:2003
Annex X: 2.3.6 This requirement is addressed in 10.2 a) of EN 14155-1:2003
Annex X: 2.3.7 This requirement is addressed in 11.2 of EN 14155-1:2003
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
kSIST FprEN ISO 14155-2:2009



FprEN ISO 14155-2:2009 (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/Notes 4.5.1 Annex 7:
1.1.1 This requirement is also addressed in A.2.5 of EN 14155-1:2003 4.5.3 Annex 7: 1.1.2 This requirement is also addressed in Clause 11 of EN 14155-1:2003 4.5.4 Annex 7: 2.3.4
Annex 7: 1.2 This requirement is addressed in A.2.5 of EN 14155-1:2003
Annex 7: 1.3 This requirement is addressed in Clause 7 of EN 14155-1:2003
Annex 7: 1.4 This requirement is not addressed in this standard
Annex 7: 1.5 This requirement is not addressed in this standard
Annex 7: 1.6 This requirement is addressed in 6.5 of EN 14155-1:2003 Entire document Annex 7: 2.3.1 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.7 Annex 7: 2.3.2 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.7 Annex 7: 2.3.3 This requirement is also addressed in 6.3 of EN 14155-1:2003 4.11 Annex 7: 2.3.5 This requirement is also addressed in 8.2 i) of EN 14155-1:2003
Annex 7: 2.3.6 This requirement is addressed in 10.2 a) of EN 14155-1:2003
Annex 7: 2.3.7 This requirement is addressed in 11.2 of EN 14155-1:2003
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. kSIST FprEN ISO 14155-2:2009



kSIST FprEN ISO 14155-2:2009



Reference numberISO 14155-2:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO14155-2First edition2003-05-15Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans Investigation clinique des dispositifs médicaux pour sujets humains — Partie 2: Plans d'investigation clinique
kSIST FprEN ISO 14155-2:2009



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kSIST FprEN ISO 14155-2:2009



ISO 14155-2:2003(E) © ISO 2003 – All rights reserved iii 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 14155-2 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 194, Biological evaluation of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read ".this European Standard." to mean ".this International Standard.". This first edition, together with the first edition of ISO 14155-1, cancels and replaces 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 For the purposes of this part of ISO 14155, the CEN annex regarding fulfilment of European Council Directives has been removed. kSIST FprEN ISO 14155-2:2009



ISO 14155-2:2003(E) iv © ISO 2003 – All rights reserved
ContentsPageForeword.vIntroduction.vi1Scope.12Normative references.13Terms and definitions.14Requirements.24.1General.24.2Clinical Investigation Plan (CIP).24.3General information.24.3.1Identification of the clinical investigation plan.24.3.2Clinical investigators, principal clinical investigator, co-ordinating clinical investigator,investigation centres/site(s).24.3.3Sponsor.24.3.4Monitoring arrangements.24.3.5Data and quality management.24.3.6An overall synopsis of the clinical investigation.34.3.7Approval and agreement to the clinical investigation plan.34.4Identification and description of the medical device to be investigated.34.5Preliminary investigations and justification of the study.34.5.1Literature review.34.5.2Preclinical testing.34.5.3Previous clinical experience.44.5.4Device risk analysis and risk assessment.44.6Objectives of the clinical investigation.44.7Design of the clinical investigation.44.8Statistical considerations.54.9Deviations from the clinical investigation plan.64.10Amendments to the clinical investigation plan.64.11Adverse events and adverse device effects.64.12Early termination or suspension of the investigation.64.13Publication policy.64.14Case Report Forms.7Annex A (informative)
Case Report Forms.8Bibliography.9kSIST FprEN ISO 14155-2:2009



ISO 14155-2:2003(E) © ISO 2003 – All rights reserved v
ForewordThis document (EN ISO 14155-2:2003) has been prepared by Technical Committee CEN /TC 258 "Clinicalinvestigation of medical devices", the secretariat of which is held by AFNOR, in collaboration with TechnicalCommittee ISO/TC 194 "Biological evaluation of medical devices".This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by November 2003, and conflicting national standards shall be withdrawn at the latestby November 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).Annex A is informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,Slovakia, Spain, Sweden, Switzerland and the United Kingdom.kSIST FprEN ISO 14155-2:2009



ISO 14155-2:2003(E) vi © ISO 2003 – All rights reserved
IntroductionThis standard is the second part of EN ISO 14155 "Clinical investigation of medical devices for human subjects",and should be read in conjunction with that standard.The standard is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design andconduct of clinical investigations. It is also intended to assist regulatory bodies and ethics committees in their rolesof reviewing Clinical Investigation Plans (CIP). The CIP is a framework within which appropriate experience, insight,judgement, qualification and education need to be applied. The scientific rigour of a CIP can be verified andpossibly improved by an independent review of the CIP.kSIST FprEN ISO 14155-2:2009



ISO 14155-2:2003(E) © ISO 2003 – All rights reserved 1 1ScopeThis part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for theclinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of thisstandard and adherence to it will help in optimising the scientific validity and reproducibility of the results of aclinical investigation.This Standard does not apply to in vitro diagnostic medical devices.2Normative references
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