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AAMI ISO 14155-1 : 2003
Withdrawn
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
08-12-2010
01-01-2008
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-1:2003
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
5.1 Declaration of Helsinki
5.2 Improper influence or inducement
5.3 Compensation and additional health care
5.4 Responsibilities
6 General requirements
6.1 Formal agreement(s)
6.2 Qualifications
6.3 Clinical investigation plan
6.4 Design of the clinical investigation
6.5 Confidentiality
6.6 Start of clinical investigation
6.7 Informed consent
6.7.1 General
6.7.2 Process of obtaining informed consent
6.7.3 Information to be provided to the subject for
the purpose of obtaining informed consent
6.7.4 Informed consent statement
6.7.5 Informed consent agreement
6.8 Suspension or early termination of the clinical
investigation
6.9 Document and data control
6.10 Accounting for subjects
6.11 Access to preclinical and clinical information
6.12 Auditing
7 Documentation
7.1 General
7.2 Clinical investigator's brochure
7.3 Other documents
8 Sponsor
8.1 General
8.2 Responsibilities of sponsor
9 Monitor
9.1 Responsibilities of monitor
10 Clinical investigator
10.1 General
10.2 Qualification of clinical investigator
10.3 Responsibilities of clinical investigator
11 Final report
11.1 Presentation of results
11.2 Contents of the final report
Annexes
A - Suggested procedure for literature review
B - Information for the ethics committees
C - Final reports of clinical investigations with medical
devices
Bibliography
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