BS EN ISO 14155-1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Clinical investigation of medical devices for human subjects General requirements
Hardcopy , PDF
28-02-2011
English
31-01-2010
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
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