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AAMI ISO 14155 : 2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GOOD CLINICAL PRACTICE
Available format(s)

Hardcopy , PDF

Superseded date

01-20-2021

Published date

12-30-2010

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Superseded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

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