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I.S. EN 60601-2-62:2015

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as ME EQUIPMENT.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
144
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
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
IEC TR 62781:2012 Ultrasonics - Conditioning of water for ultrasonic measurements
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 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
IEC TR 62649:2010 Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices
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
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
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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