DIN EN ISO 14155-2 E : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
Hardcopy , PDF
01-01-2012
English
01-01-2003
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Requirements<br>Annex A (informative) - Case Report Forms<br>Bibliography<br>Annex ZA (informative) Relationship between this European Standard<br> and the Essential Requirements of EU Directive 93/42/EEC<br> on Medical Devices<br>Annex ZB (informative) Relationship between this European Standard<br> and the Essential Requirements of EU Directive 90/385/EEC<br> 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Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 14155-2:2003 | Identical |
| EN ISO 14155-2:2009 | Identical |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| DIN EN ISO 10993-10:2003-02 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
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