BS EN ISO 14155-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Clinical investigation plans
Hardcopy , PDF
28-02-2011
English
31-01-2010
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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 the clinical investigation of medical devices.
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes 01/562358 DC (06/2003)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
| Standards | Relationship |
| EN ISO 14155-2:2009 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| I.S. EN ISO 14155-2:2009 | Identical |
| UNI EN ISO 14155-2 : 2009 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| NEN EN ISO 14155-2 : 2009 | Identical |
| SN EN ISO 14155-2 : 2010 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| ISO 14155-2:2003 | Identical |
| DIN EN ISO 14155-2:2009-11 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| DIN EN ISO 14155-2:2003-09 | Identical |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
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