DIN EN ISO 14155-1:2003-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: GENERAL REQUIREMENTS
Hardcopy , PDF
01-01-2012
English
01-01-2003
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 |
Together with DIN EN ISO 14155-2 E Supersedes DIN EN 540 E (02/2004)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| UNE-EN ISO 14155-1:2009 | Identical |
| I.S. EN ISO 14155-1:2009 | Identical |
| UNI 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 |
| BS EN ISO 14155-1:2009 | Identical |
| EN ISO 14155-1:2009 | Identical |
| NF EN ISO 14155-1 : 2009 | 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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