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YY 9706.262-2021: Medical electrical equipment -- Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment
YY 9706.262-2021
Medical electrical equipment -- Part 2-62.Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standard
Medical Electrical Equipment Part 2-62.High Intensity Ultrasound
Basic safety and essential performance of therapeutic (HITU) equipment
Dedicated requirements
equipment
(IEC 60601-2-62.2013, MOD)
Published on 2021-03-09
2023-05-01 Implementation
Released by the State Drug Administration
Medical Electrical Equipment Part 2-62.High Intensity Ultrasound
Basic safety and essential performance of therapeutic (HITU) equipment
Dedicated requirements
201.1 Scope, Purpose and Related Standards
Clause 1 of the General Standard applies except as follows.
201.1.1 Scope
Increase.
This section applies to the basic safety and basic performance of high-intensity ultrasound therapy equipment (hereinafter referred to as ME equipment).
This section adds or replaces the specific clauses in GB 9706.1 for high-intensity ultrasound therapy equipment.
If a chapter or subclause is specifically intended to apply only to ME EQUIPMENT, or only to ME SYSTEMS, state it in the title or content of the chapter or subclause
Bright. If this is not the case, the clause or clause applies to both ME EQUIPMENT and ME SYSTEMS.
ME EQUIPMENT and ME SYSTEMS within the scope of this standard, inherent hazards in their intended physiological functions, except for general standard 7.2.13 and
8.4.1, not included in the special requirements of this section.
Note 1.See also 4.2 of the general standard.
Note 2.In the HITU sound field, due to the influence of nonlinear propagation, it is expected that the sound waveform will be severely distorted, so the ultrasonic measurement should be under quasi-linear conditions,
Then extrapolate according to the steps given in IEC /T S62556, see IEC /T S61949.
Note 3.An asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines and rationales related to the item in Appendix AA
illustrate.
This section also applies to.
--- Thrombolytic therapy devices exposed to high-intensity therapeutic ultrasound;
--- Occlusive vasa vasorum treatment equipment exposed to high-intensity therapeutic ultrasound;
--- Devices intended to relieve pain on bones caused by cancer metastases.
This section does not apply to.
--- Ultrasound equipment for physiotherapy (applicable. GB 9706.205 and YY/T 0750);
--- Ultrasonic equipment for gravel (applicable. GB 9706.22);
--- Ultrasound equipment for hyperthermia;
--- Ultrasound equipment for cataract emulsification.
201.1.2 Purpose
replace.
The purpose of this section is to specify specific requirements for the essential safety and essential performance of high-intensity ultrasound therapy equipment (HITU).
201.1.3 Tied standards
Increase.
This part refers to the applicable collateral standards listed in Chapter 2 of the General Standard and.201.2 of this part.
In Chapter 202, the revision adopts YY 9706.102.Others use all published side-by-side standards of the 9706 series.
---Time window average sound intensity, Iw, Δt/s(t);
--- Entering effective sound intensity set for clinical application, including distance ZE;
--- Peak sparse sound pressure set for clinical applications;
--- distance Zr;
--- High temperature effects (eg, vaporization effects caused by overheating).
201.11 Protection against ultra-temperature and other hazards (sources)
Clause 11 of the General Standard applies except as follows.
201.11.6.5 Intrusion of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Increase.
201.11.6.5.101 According to GB/T 4208, the treatment head of the expected handheld device should reach IPX7.
Should be in accordance with GB/T 4208, the treatment head and the inlet including the connecting line are tested to check whether they meet the requirements.
Temporary protection of parts of the transducer assembly that are not intended to be immersed in water during normal use may be provided during the test.
201.12 Accuracy of controls and instruments and protection of hazardous outputs
Clause 12 of the General Standard applies except as follows.
201.12.1 Accuracy of controllers and instruments
Increase.
201.12.1.101 Patient entry power
Accuracy of patient access power data and controls should be specified in the technical specification.
The evaluation of uncertainty should use the ISO representation method for measurement uncertainty [18].
201.12.1.102 Aiming accuracy
The accuracy of the data and controls for targeting should be specified in the technical specification.
The evaluation of uncertainty should use the ISO representation method for measurement uncertainty [18].
201.12.1.103 Accuracy of thermal equivalent time
If the thermal equivalent time is to be displayed, the uncertainty for determining the thermal equivalent time should be given in the technical specification.
If thermal equivalent time is to be displayed, either measured or estimated, depending on the setup and model, the technical specification should give its
source.
The value of the thermal equivalent time depends on the determination of the tissue type, so the thermal equivalent time should be stated for the type of tissue being treated. answer
Differences between various tissue properties are explained based on studies of living tissue.
The evaluation of uncertainty should use the ISO representation method for measurement uncertainty [18].
201.12.4 Protection of hazardous outputs
201.12.4.4 Incorrect output
Increase.
201.12.4.4.101 Output Control
The incoming power and incoming effective sound intensity should be given in relation to the control settings.
Compliance is checked according to the method described in IEC 62555.
Even if the equipment has an automatic stop function, the ME EQUIPMENT or SYSTEM shall be equipped with a manual panic button for cutting off the ultrasonic excitation voltage.
Risk management procedures should cover other hazards associated with activating the panic button.
201.12.4.4.102 Aiming accuracy
Guidance for the use of the positioning device to determine the target tissue should be given to illustrate the three-dimensional structure of the target and surrounding tissue.
The uncertainty of the positioning device used to locate the point of the maximum pulsed sound pressure square integral value on the ultrasonic beam axis at the target position should be given.
fixed.
201.12.4.4.103 *Unexpected output level
The magnitude of the side lobe peak time-averaged sound intensity should be given based on measurements and/or modeling, and the point relative to the focal area or maximum sound beam area should be given
The position of the maximum sound intensity point in the domain.
Risk assessment procedures should demonstrate that the risk of possible damage to tissue outside the target area during ultrasound irradiation is acceptable.
Note 1.See Appendix DD for information demonstrating that minimal tissue damage occurs.
Compliance is checked according to the method described in IEC /T S62556.
The magnitude of the pre-focal peak time-averaged sound intensity should be given based on measurements and/or modeling, and the point relative to the focal area or maximum sound beam area should be given
The position of the maximum sound intensity point in the domain.
Risk assessment procedures should demonstrate that the risk of possible damage to tissue outside the target area during ultrasound irradiation is acceptable.
Note 2.See Appendix DD for information demonstrating minimal tissue damage.
Compliance is checked according to the method described in IEC /T S62556.
If critical structures other than the target location are irradiated by ultrasound, the temperature rise at these critical structures should be limited according to the risk assessment
at acceptable values.
The acceptable risk of adjacent tissue damage should be weighed against the benefit that can be obtained from treatment.
Compliance is checked by the method described in Annex CC.
201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAILURE STATES
Increase.
201.13.101
For tissue exposed to ultrasound outside the target location, the temperature rise and thermal equivalence time should be limited to acceptable
numerical value.
201.14 Programmable Medical Electrical System (PEMS)
Clause 14 of the General Standard applies.
201.15 Structure of ME equipment
Clause 15 of the General Standard applies.
201.16 ME System
Clause 16 of the General Standard applies.
201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the General Standard applies except as follows.
Increase.
High-intensity ultrasound therapy equipment shall comply with the requirements of YY 9706.102 as amended by Chapter 202.
202 Electromagnetic compatibility - requirements and tests
Except for the following, YY 9706.102 applies.
202.6 Electromagnetic compatibility
202.6.1 Launch
202.6.1.1 Protection of radio services
202.6.1.1.1 Requirements
replace.
Except for the exceptions and instructions specified in a) and b) below, high-intensity ultrasound therapy equipment shall be in accordance with GB 4824, according to the manufacturer's instructions for use
The intended use specified in the manual is classified as Group 1 Class A or Class B. See Appendix EE for the classification guidelines of GB 4824.
a) ME EQUIPMENT and ME SYSTEMS specified for use only in shielded locations
--- For ME EQUIPMENT and ME SYSTEMS specified for use only in shielded locations, when tested at the test site, only the minimum radio frequency
The technical requirements for shielding effectiveness meet the requirements specified in 5.2.2.3b), and the electromagnetic radiation disturbance limit of GB 4824 can be increased.
Add up to the maximum value specified for the corresponding minimum RF shielding effectiveness.
--- For ME EQUIPMENT and ME SYSTEMS specified for use only in shielded locations, when tested at the test site, only the minimum radio frequency
The technical requirements for filter attenuation meet the requirements specified in 5.2.2.3b). Only the power supply terminal disturbance voltage limit of GB 4824 can be
Increase, the increased value for all cables drawn from the shielded place can reach the specified value of the corresponding minimum filter attenuation.
b) for radio equipment containing radio equipment that has been tested and found to comply with the applicable national radio regulations
ME EQUIPMENT and ME SYSTEMS, if the emission limits of the applicable National Radio Regulations are less than or equal to the applicable CISPR standard
The corresponding electromagnetic disturbance limit value can be exempted from the test required by CISPR electromagnetic disturbance. ME EQUIPMENT containing RF transmitters and
ME systems are exempt from the emission requirements of this part in the dedicated emission frequency band of the transmitter. Otherwise the emission requirements of this part shall apply
For ME EQUIPMENT and ME SYSTEMS intended only for use in countries without national radio regulations, the emission requirements of this part
should also apply.
test file
The test documentation shall include the test method used to verify compliance with the requirements of this subclause and a justification for the use of any deviations from this part. document
Shall include information on the ME EQUIPMENT or ME SYSTEM under test, test equipment and test arrangements, ME EQUIPMENT or ME SYSTEM settings and modes, cable routing
Bureau and a description of all patient physiology simulators, accessories, and subsystem simulators used.
202.6.1.1.2 Test
Clause a) adds.