ANSI/AAMI/ISO 16142-1:2016

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

This part of ISO 16142, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended and describes the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).