EN 540 : 1993
Superseded
Superseded
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
Published date
01-12-2013
Publisher
Superseded date
02-01-2003
Superseded by
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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.
| Committee |
CEN/TC 258
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 540 : 1993 | Identical |
| NF EN 540 : 1993 | Identical |
| NEN EN 540 : 1994 | Identical |
| NS EN 540 : 1ED 1993 | Identical |
| I.S. EN 540:1994 | Identical |
| AS EN 540-2002 | Identical |
| BS EN 540:1993 | Identical |
| DIN EN 540:1993-07 | Identical |
| UNE-EN 540:1994 | Identical |
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