DIN EN ISO 14155-2 E : 2003

Name: DIN EN ISO 14155-2 E : 2003
Brand: DIN

Superseded

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Superseded date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

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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Status	Superseded
Supersedes	DIN EN 540:1993-07

Standards	Relationship
ISO 14155-2:2003	Identical
EN ISO 14155-2:2009	Identical

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