DIN EN ISO 14155-1:2003-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: GENERAL REQUIREMENTS
Hardcopy , PDF
01-01-2012
English
01-01-2003
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.