ANSI/AAMI/ISO 16142-1:2016
Current
The latest, up-to-date edition.
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Hardcopy , PDF
English
07-07-2016
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 16142-1:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
of medical devices
5 Use of standards and guides in support of the
essential principles
6 Essential principles and references to relevant
standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential principles
to standards
Annex C (informative) - Website listings of other standards
suitable for the medical device sector and for
assessment purposes
Annex D (informative) - Reference to the essential principles
by International Standards
Annex E (informative) - Terminology - alphabetized index
of defined terms
Bibliography
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