Name: DIN EN ISO 14155-1 E : 2003
Brand: DIN

DIN EN ISO 14155-1 E : 2003

Superseded

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS

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Superseded date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 Justification for a clinical investigation 5 Ethical considerations 6 General requirements 7 Documentation 8 Sponsor 9 Monitor 10 Clinical investigator 11 Final report Annex A (informative) - Suggested procedure for literature         review Annex B (informative) - Information for the ethics         committees Annex C (informative) - Final reports of clinical         investigations with medical devices 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 procedures for the conduct and performance of clinical investigations of medical devices. Applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

DevelopmentNote	Together with DIN EN ISO 14155-2 E Supersedes DIN EN 540 E (02/2004)
DocumentType	Standard
Pages	26
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
Supersedes	DIN EN 540:1993-07

Standards	Relationship
ISO 14155-1:2003	Identical
EN ISO 14155-1:2009	Identical

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