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SN EN 540 : 1998

Current

Current

The latest, up-to-date edition.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS

Published date

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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