I.S. EN 540:1994
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
Hardcopy , PDF
16-05-2003
English
01-01-1994
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market.
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 540 : 1994 | Identical |
| NF EN 540 : 1993 | Identical |
| BS EN 540:1993 | Identical |
| NBN EN 540 : 1993 | Identical |
| UNI EN 540 : 1995 | Identical |
| SN EN 540 : 1998 | Identical |
| NS EN 540 : 1ED 1993 | Identical |
| EN 540 : 1993 | Identical |
| UNE-EN 540:1994 | Identical |
| DIN EN 540:1993-07 | Identical |
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