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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
Hardcopy , PDF
20-01-2021
30-12-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded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 |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| MEDDEV 2.12-1 : REV 8 : 2013 | GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
| 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 |
| MEDDEV 2.12-2 : REV 2012 | POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.