Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Published date

22-05-2015

Publisher

European Committee for Standards - Electrical

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.

Committee	CLC/TC 62
DocumentType	Standard
PublisherName	European Committee for Standards - Electrical
Status	Current

Standards	Relationship
IEC 60601-2-62:2013	Identical
NF EN 60601-2-62 : 2015	Identical
NBN EN 60601-2-62 : 2015	Identical
NEN EN IEC 60601-2-62 : 2015	Identical
I.S. EN 60601-2-62:2015	Identical
PN EN 60601-2-62 : 2015	Identical
VDE 0750-2-62 : 2016	Identical
DIN EN 60601-2-62 : 2016	Identical
SN EN 60601-2-62:2015	Identical
BS EN 60601-2-62:2015	Identical
CEI EN 60601-2-62 : 2016	Identical
UNE-EN 60601-2-62:2015	Identical

IEC 62127-1:2007+AMD1:2013 CSV	Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
IEC 60601-2-5:2009	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 62464-1:2007	Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
IEC 61689:2013	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
IEC 62555:2013	Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
IEC 60050-802:2011	International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
IEC 61828:2001	Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
EN 61828:2001	Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
EN 60601-2-5:2015	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC TR 62781:2012	Ultrasonics - Conditioning of water for ultrasonic measurements
EN 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 61689:2013	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
EN 60601-1-2:2015	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-2-36:2015	Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
EN 62127-2:2007/A2:2017	ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	Degrees of protection provided by enclosures (IP Code)
IEC 62127-2:2007+AMD1:2013+AMD2:2017 CSV	Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz
EN 62555:2014	Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
IEC TS 61949:2007	Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams
EN 60529:1991/AC:2016-12	DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
IEC 62359:2010+AMD1:2017 CSV	Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
CLC/TS 61949:2008	Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams
EN 62127-1:2007/A1:2013	ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
IEC 60601-2-36:2014	Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
IEC TS 62556:2014	Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
EN 62464-1:2007	Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
ISO/IEC Guide 98-3:2008	Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)