I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - PART 2: CLINICAL INVESTIGATION PLANS
Hardcopy , PDF
09-02-2011
English
01-01-2009
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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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
Gives requirements for the preparation of a Clinical Investigation Plan (CIP) for 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.
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 14155-2 : 2009 | Identical |
| SN EN ISO 14155-2 : 2010 | Identical |
| EN ISO 14155-2:2009 | Identical |
| NF EN ISO 14155-2 : 2009 | Identical |
| BS EN ISO 14155-2:2009 | Identical |
| UNI EN ISO 14155-2 : 2009 | Identical |
| NBN EN ISO 14155-2 : 2009 | Identical |
| UNE-EN ISO 14155-2:2009 | Identical |
| ISO 14155-2:2003 | Identical |
| NS EN ISO 14155-2 : 2009 | Identical |
| DIN EN ISO 14155-2:2009-11 | 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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