SN EN 540 : 1998
Current
The latest, up-to-date edition.
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
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 |
Swiss Standards
|
| Status |
Current
|
| 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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