BS 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

Specifies the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

This document, which includes 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. This document identifies and describes the six general essential principles of safety and performance (see TableB.1) that apply to all medical devices, including IVD medical devices (in vitro diagnostic).

This document also identifies and describes the additional essential principles of safety and performance which need to be considered during the design and manufacturing process, which are relevant to IVD medical devices.

NOTE During the design process, the manufacturer selects which of the listed design and manufacturing principles apply to the particular medical device and documents the reasons for excluding others.

This document is intended for use as guidance by medical devicemanufacturers, standards development organizations, authorities having jurisdiction, and conformity assessment bodies.