Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established
6 Requirements for accompanying information
7 Other information that is required to be supplied with the medical device or accessory
Annex A (informative) Particular guidance and rationale
Annex B (informative) Example test method for assessing clearly legible requirements
Annex C (informative) Example test method for assessing durability
Annex D (informative) Cross reference between the document and the requirements
considered
Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
Annex F (informative) Reference to the essential principles
Annex G (informative) Reference to the general safety and performance requirements for
medical devices
Annex H (informative) Reference to the general safety and performance requirements for
IVD medical devices
Annex I (informative) Terminology — Alphabetized index of defined terms
Bibliography