ANSI/AAMI/ISO 16142-2:2017

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
 of ISO 16142-2:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
  of IVD 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

Covers the essential principles of safety and performance, 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.