BS EN ISO 14155:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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. Good clinical practice
Hardcopy , PDF
08-19-2020
English
09-30-2011
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical
investigation
8 Responsibilities of the sponsor
9 Responsibilities of the principal investigator
Annex A (normative) - Clinical investigation plan (CIP)
Annex B (normative) - Investigator's brochure (IB)
Annex C (informative) - Case report forms (CRFs)
Annex D (informative) - Clinical investigation report
Annex E (informative) - Essential clinical investigation
documents
Annex F (informative) - Adverse event categorization
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
Describes good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes BS EN ISO 14155-1, BS EN ISO 14155-2 and 08/30116059 DC. (02/2011)
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 14155:2011 | Identical |
| EN ISO 14155:2011 | Identical |
| ISO 14155:2011/Cor 1:2011 | Identical |
| BS 70000:2017 | Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence |
| BIP 0113 : 2012 | GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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