AAMI 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
30-12-2010
20-01-2021
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14155:2011
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
Specifies 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 |
WG 04
|
| DevelopmentNote |
Supersedes AAMI ISO 14155-1 and AAMI ISO 14155-2. (03/2011)
|
| DocumentType |
Standard
|
| Pages |
75
|
| ProductNote |
NEW CHILD ERR 1 IS NOW ADDED.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
A newer version of this standard is available.
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