Foreword
Introduction
1 Scope
2 Terms and definitions
3 Essential principles of safety and performance of medical
devices
4 Use of standards and guides in support of regulatory
requirements
5 Essential principles and references to relevant standards
or guides
6 How to find relevant standards
Annex A (informative) Table relating essential principles
to standards
Annex B (informative) Examples of reference to basic
standards
Annex C (informative) Website listings of other standards
suitable for the medical device sector and for
assessment purposes
Annex D (informative) Information on the Global
Harmonization Task Force
Bibliography