EN 540 : 1993
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
12-01-2013
01-02-2003
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Superseded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 |