FOREWORD
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
7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER
(PCLC) development
Annex A (informative) - General guidance and rationale
Annex B (informative) - Description of dynamic performance
of a PCLCS
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Bibliography
Index of defined terms used in this collateral standard