CEI EN 60601-2-62 : 2016
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
Hardcopy , PDF
English
01-01-2016
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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, hereafter referred to as ME EQUIPMENT.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-239. (02/2016)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Standards | Relationship |
| IEC 60601-2-62:2013 | Identical |
| 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 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 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 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 |
| 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 TS 62556:2014 | Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems |
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