DIN EN ISO 14155-2:2003-09
Superseded
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
Hardcopy , PDF
English
09-01-2003
01-01-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) - Case Report Forms
Bibliography
Annex ZA (informative) Relationship between this European Standard
and the Essential Requirements of EU Directive 93/42/EEC
on Medical Devices
Annex ZB (informative) Relationship between this European Standard
and the Essential Requirements of EU Directive 90/385/EEC
on Active Implantable Medical Devices
Specifies requirements for the preparation of a Clinical Investigation Plan (CIP) for clinical investigation of medical devices.
| DevelopmentNote |
Together with DIN EN ISO 14155-1 E supersedes DIN EN 540 E. (02/2004)
|
| DocumentType |
Standard
|
| Pages |
13
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| EN ISO 14155-2:2009 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| NEN EN ISO 14155-2 : 2009 | Identical |
| ISO 14155-2:2003 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| I.S. EN ISO 14155-2:2003 | Equivalent |
| BS EN ISO 14155-2:2003 | Equivalent |