DIN EN ISO 14155-1:2003-09

Name: DIN EN ISO 14155-1:2003-09
Brand: DIN

Superseded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Superseded date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Status	Superseded

Standards	Relationship
UNE-EN ISO 14155-1:2009	Identical
I.S. EN ISO 14155-1:2009	Identical
UNI EN ISO 14155-1 : 2009	Identical
NBN EN ISO 14155-1 : 2009	Identical
SN EN ISO 14155-1 : 2010	Identical
NEN EN ISO 14155-1 : 2009	Identical
ISO 14155-1:2003	Identical
NS EN ISO 14155-1 : 2009	Identical
BS EN ISO 14155-1:2009	Identical
EN ISO 14155-1:2009	Identical
NF EN ISO 14155-1 : 2009	Identical

ISO 14155-2:2003	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
ISO 14971:2007	Medical devices Application of risk management to medical devices