UNI EN 540 : 1995
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
17-11-2005
12-01-2013
Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope
2. Normative references
3. Terminology and definitions
4. General requirements
5. Methodology
6. Presentation of results
Annex A (informative) Bibliography
National annex NA (informative) Committees responsible
Defines procedures to help manufacturers, regulatory authorities, sponsors and clinical investigators on the conduct and performance of the clinical investigation of medical devices. Also includes terminology and definitions.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| BS EN 540:1993 | Identical |
| DIN EN 540:1993-07 | Identical |
| I.S. EN 540:1994 | Identical |
| EN 540 : 1993 | Identical |
| UNE-EN 540:1994 | Identical |
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