Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Essential principles of safety and performance<br>&nbsp;&nbsp;of medical devices<br>5 Use of standards and guides in support of the<br>&nbsp;&nbsp;essential principles<br>6 Essential principles and references to relevant<br>&nbsp;&nbsp;standards and guides<br>Annex A (informative) - Rationale and guidance<br>Annex B (normative) - Table relating essential principles<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;to standards<br>Annex C (informative) - Website listings of other standards<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;suitable for the medical device sector and for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;assessment purposes<br>Annex D (informative) - Reference to the essential principles<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by International Standards<br>Annex E (informative) - Terminology - alphabetized index<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of defined terms<br>Bibliography

Abstract

Gives 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.

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Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/210
Supersedes	BS PD ISO/TR 16142 : 2006 14/30290166 DC : 0