MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT
International Electrotechnical Committee
FOREWORD
INTRODUCTION
INTRODUCTION TO AMENDMENT 1
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
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
202.6 ELECTROMAGNETIC COMPATIBILITY
Annex AA (informative) - Guidance and rationale for particular
subclauses
Annex BB (informative) - Guidance in classification according
to CISPR 11
Annex CC (informative) - Guidance to the MANUFACTURER on the
interpretation of TI and MI to be used to inform the
OPERATOR
Annex DD (informative) - Example set-up to measure surface
temperature of externally applied TRANSDUCER ASSEMBLIES
Annex EE (informative) - Acoustic output table intended
for 3rd parties
Bibliography
Index of defined terms
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
