eLibrary >
ANSI/AAMI/ISO 16142-2:2017 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the se >
ANSI/AAMI/ISO 16142-2:2017 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the se, 2017
- ANSI/AAMI/ISO 16142-2:2017; Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
- Objectives and uses of AAMI standards andrecommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- 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 [Go to Page]
- 6 Essential principles and references to relevant standards and guides [Go to Page]
- Annex A (informative) Rationale and guidance [Go to Page]
- Annex B (normative) Table relating essential principles to standards [Go to Page]
- Annex C (informative) Website listings of other standards suitable for the medical device sectorand for assessment purposes
- Annex D (informative) Reference to the essential principles by International Standards [Go to Page]
- Annex E (informative) Terminology—Alphabetized index of defined terms
- Bibliography [Go to Page]