EN 60601-2-62:2015

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 of
       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
202 Electromagnetic compatibility - Requirements
       and tests
Annexes
Annex AA (informative) - Particular guidance
         and rationale
Annex BB (informative) - Targeting
Annex CC (informative) - HITU - specific risks
Annex DD (informative) - Determining regions of
         HITU fields for measurement
Annex EE (informative) - Guidance in classification
         according to CISPR 11
Annex FF (informative) - Notes on using a saline
         or water bath for EMI testing
Index of defined terms used in this particular standard
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

IEC 60601-2-62:2013 applies to the basic safety and essential performance of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT. If a clause or subclause is specifically intended to be applicable to such equipment only, or to related systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to individual equipment and to systems, as relevant. Hazards inherent in the intended physiological function of the equipment or systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to - therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound; - therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound; - and equipment intended to be used for relieving cancer pain due to bone metastases. This particular standard does not apply to - Ultrasound Equipment intended to be used for physiotherapy (use IEC 60601-2-5 and IEC 61689); - Ultrasound Equipment intended to be used for lithotripsy (use IEC 60601-2-36); - Ultrasound Equipment intended to be used for dedicated hyperthermia devices; and - Ultrasound Equipment intended to be used for phacoemulsification.