Table of Contents

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME
       EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME
       EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
       HAZARDS
201.11 Protection against excessive temperatures and other
hazards
201.12 ACCURACY of controls and instruments and protection
       against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
       for ME EQUIPMENT
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
       ME SYSTEMS
Annexes
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and
        ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - Evaluating ME EQUIPMENT
         performance using the FUNCTIONAL NIRS PHANTOM
Annex CC (informative) - Reference to the essential principles
Bibliography
Index of defined terms

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN