AS/NZS IEC 60601.2.62:2022
Medical electrical equipment, Part 2.62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Standard identically adopts IEC 60601‐2‐62:2013 which specifies safety requirements additional to those in IEC 60601‐1 for high intensity therapeutic ultrasound equipment. It adds or replaces clauses listed in IEC 60601‐1 that are specific for high intensity therapeutic ultrasound equipment. Applies to the basic safety and essential performance of high intensity therapeutic ultrasound equipment.
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AS/NZS IEC 60601.2.62:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
English
CONTENTS
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
Figures
Figure 201.101 – Schematic diagram showing the relationship between the variousdefined surfaces and distances for an ULTRASONIC TRANSDUCER with water stand-offdistance when applied to a PATIENT. [IEC 61157 Ed2]
Figure 201.102 – Parameters for describing a focusing transducer of a known geometry
Figure 201.103 – Example set-up for the measurement of the unwantedultrasound radiation on the side-wall (the handle) of the transducer
Figure DD.1 – Illustration of target, intermediate (shaded or yellow) region and safe regions defined by boundaries 1 and 2
Figure DD.2 – Exposure time vs temperature increase above 37€°C for three different bioffects threshold exposures shown as solid curves
Figure DD.3 – Two-layer model with target
Figure DD.4 – temporal-average intensity (in€dB) corrected for absorption vs transverse dimension in the focal plane
Figure DD.5 – TEMPORAL-AVERAGE INTENSITY (in dB) vs axial distance z (mm) for abeam from a spherical focusing transducer with a radius of 20 mm and a geometricfocal length of 40 mm at 1 MHz
Figure DD.6 – Overlapping multiple exposure regions in a target region depictedby the dark ellipse
Figure FF.1 – Representing the patient or operator impedance
Figure FF.2 – Possible setup for artificial hand for HITU equipment
Figure FF.3 – Showing copper band in saline
Tables
Table 201.101 – List of symbols & abbreviations
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements
Table CC.1 – Hazards related to image to focus misalignment
Table CC.2 – Hazards related to use of HITU device byunskilled or untrained personnel or reasonably foreseeable misuse
Table CC.3 – Hazards arising from improper acoustic energy
Table CC.4 – Lack of, or inadequate, specification for maintenance includinginadequate specification of post-maintenance functional checks
Table CC.5 – Miscellaneous hazards
Table CC.6 – Data transfer errors
Table CC.7 – HITU transducer failure
Table CC.8 – Generator failure
Table CC.9 – Cooling system failure
Table CC.10 – Software gets stuck in endless loop
Table CC.11 – Wrong calculations by computer
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AS/NZS IEC 60601.2.62:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
English
CONTENTS
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
Figures
Figure 201.101 – Schematic diagram showing the relationship between the variousdefined surfaces and distances for an ULTRASONIC TRANSDUCER with water stand-offdistance when applied to a PATIENT. [IEC 61157 Ed2]
Figure 201.102 – Parameters for describing a focusing transducer of a known geometry
Figure 201.103 – Example set-up for the measurement of the unwantedultrasound radiation on the side-wall (the handle) of the transducer
Figure DD.1 – Illustration of target, intermediate (shaded or yellow) region and safe regions defined by boundaries 1 and 2
Figure DD.2 – Exposure time vs temperature increase above 37€°C for three different bioffects threshold exposures shown as solid curves
Figure DD.3 – Two-layer model with target
Figure DD.4 – temporal-average intensity (in€dB) corrected for absorption vs transverse dimension in the focal plane
Figure DD.5 – TEMPORAL-AVERAGE INTENSITY (in dB) vs axial distance z (mm) for abeam from a spherical focusing transducer with a radius of 20 mm and a geometricfocal length of 40 mm at 1 MHz
Figure DD.6 – Overlapping multiple exposure regions in a target region depictedby the dark ellipse
Figure FF.1 – Representing the patient or operator impedance
Figure FF.2 – Possible setup for artificial hand for HITU equipment
Figure FF.3 – Showing copper band in saline
Tables
Table 201.101 – List of symbols & abbreviations
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements
Table CC.1 – Hazards related to image to focus misalignment
Table CC.2 – Hazards related to use of HITU device byunskilled or untrained personnel or reasonably foreseeable misuse
Table CC.3 – Hazards arising from improper acoustic energy
Table CC.4 – Lack of, or inadequate, specification for maintenance includinginadequate specification of post-maintenance functional checks
Table CC.5 – Miscellaneous hazards
Table CC.6 – Data transfer errors
Table CC.7 – HITU transducer failure
Table CC.8 – Generator failure
Table CC.9 – Cooling system failure
Table CC.10 – Software gets stuck in endless loop
Table CC.11 – Wrong calculations by computer
AS/NZS IEC 60601.2.62:2022
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.