I.S. EN ISO 14155-1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: GENERAL REQUIREMENTS
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
7 Documentation
8 Sponsor
9 Monitor
10 Clinical investigator
11 Final report
Annex A (informative) - Suggested procedure for literature
review
Annex B (informative) - Information for the ethics
committees
Annex C (informative) - Final reports of clinical
investigations
with medical devices
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 procedures for the conduct and performance of clinical investigations of medical devices. Applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
| DevelopmentNote |
Supersedes I.S. EN 540 (05/2004)
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 14155-1:2009 | Identical |
| NF EN ISO 14155-1 : 2009 | Identical |
| UNE-EN ISO 14155-1:2009 | Identical |
| UNI EN ISO 14155-1 : 2009 | Identical |
| BS EN ISO 14155-1:2009 | Identical |
| NBN EN ISO 14155-1 : 2009 | Identical |
| SN EN ISO 14155-1 : 2010 | Identical |
| NEN EN ISO 14155-1 : 2009 | Identical |
| ISO 14155-1:2003 | Identical |
| NS EN ISO 14155-1 : 2009 | Identical |
| DIN EN ISO 14155-1:2009-11 | Identical |
| DIN EN ISO 14155-1:2003-09 | Identical |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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