INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 Accuracy of controls and instruments and protection
against hazardous outputs
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER
(PCLC) development
Annex A - General guidance and rationale
Annex C - Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS