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DIN EN ISO 14155-2:2003-09

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS

Available format(s)

Hardcopy , PDF

Superseded date

01-01-2012

Language(s)

English

Published date

01-01-2003

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) - Case Report Forms
Bibliography
Annex ZA (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
         on Medical Devices
Annex ZB (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 90/385/EEC
         on Active Implantable Medical Devices

Specifies requirements for the preparation of a Clinical Investigation Plan (CIP) for clinical investigation of medical devices.

DevelopmentNote
Together with DIN EN ISO 14155-1 E supersedes DIN EN 540 E. (02/2004)
DocumentType
Standard
Pages
13
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)

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