YY 0592-2016High intensity focused ultrasound therapy system (English PDF)

3.1 High intensity focused ultrasound therapy system

a therapy system that focused ultrasound source consisting of cell transducer or multivariate transducer array sends ultrasound;

3.2 Acoustic pressure focal region

focal domain it includes the space body surrounded by the interfaces in which the acoustic pressure focus and its acoustic pressure value are 6 dB lower than acoustic pressure peak (0 dB)

3.3 Acoustic pressure focal area

the acoustic pressure focal plane, the area enclosed by the focal point of the acoustic pressure and its acoustic pressure level 6 dB lower than the acoustic pressure peak (0 dB) unit.

4.2 Product composition

HIFU therapy system generally consists of the following devices (or parts).

5.1 Sound field characteristics

5.1.2 Longitudinal size of focal region

It shall not exceed the nominal value announced by the manufacturer.

5.1.3 Maximum side lobe level

The side lobe amplitude at the acoustic pressure focal plane shall be more than 8 dB less than the main lobe amplitude (focal acoustic pressure).

5.2 Sound working frequency deviation

The manufacturer shall publish the nominal operating frequency of the transducer sound. The maximum deviation of the sound operating frequency shall not exceed ±15% of the nominal value.

5.3 Ultrasonic power and control

5.3.1 The manufacturers shall publish the maximum output sound power and deviation.

5.4 Localization device

5.4.1 If using ultrasound imaging equipment as localization device, the main technical performance requirements are as follows.

5.4.2 If using other medical imaging equipment as localization device, its technical performance shall meet the requirements for localization of HIFU therapy system.

5.5 Positioning device

5.5.1 Movement range and error

The maximum stroke in each axis, the cumulative error and treatment head, ultrasonic imaging equipment probe angle of the positioning device (treatment head or patient support device) shall be consistent with the manufacturer's instructions.

5.8 Appearance and structure

5.8.1 It shall look neat, in uniform color, no scars, scratches or other defects.

5.8.2 The control and adjustment mechanism shall be flexible and reliable, no loose fastening parts.

5.8.3 Rubber, plastic parts shall have no blistering, cracking, deformation.

5.8.4 Sinks, water bags and water connections shall have no media leakage.

5.9 Water treatment facility

For HIFU therapy system with medium temperature control, degassing device, the effects after therapy are required as follows. […]

5.10 Electrical safety requirements

In accordance with relevant requirements of GB 9706.1-2007 and other applicable parallel or special safety standards.

5.11 Electromagnetic compatibility

In accordance with relevant requirements of YY 0505.

5.12 Environmental test requirements

The environmental test conditions for HIFU therapy system shall be in accordance with GB/T 14710.

6.2 Measurement system requirements

In accordance with Clause 5 of GB/T 19890-2005.

6.3 Measurement of acoustic field distribution characteristics

Since only the acoustic pressure relative value is required by the sound field distribution characteristic test, it shall use hydrophone with uncorrected sensitivity but less than 10% nonlinear distortion.

6.3.3 Measurement of maximum side lobe level

Find the second maximum (secondary maximum) in the distribution of acoustic pressure effective value in the acoustic pressure focal plane.

Calculate the maximum side lobe level according to equation (2) in accordance with requirements of 5.1.3.

6.4 Measurement of maximum acoustic intensity of focal region

6.4.1 Measurement of average acoustic intensity of special peak time

It shall use the hydrophone with calibrated sensitivity. Set the pulse duration of testing HIFU therapy system less than or equal to 100 µs, pulse repetition frequency less than 1 kHz.

6.5 Measurement of acoustic operating frequency deviation

The measurement of acoustic operating frequency shall be carried out according to the method specified in 7.3.1.2 of GB/T 19890-2005. Its deviation meets requirements of 5.2.

6.6 Ultrasound power and control

Respectively set the maximum value and the minimum value for output acoustic intensity or acoustic power of HIFU therapy system. Detect the acoustic intensity or acoustic power according to the method of GB/T 19890.

Calculate the detected data. The result shall comply with the requirements of 5.3.1 and 5.3.2.

6.13 Safety performance

Carry out according to relevant method of GB 9706.1-2007 and other applicable parallel or particular safety standards.

6.14 Electromagnetic compatibility

Carry out in accordance with YY 0505.

6.15 Environmental test

Carry out according to the method and procedures specified in GB/T 14710.

7.1 Exit-factory inspection

The number of sample, inspection items, determination rules of exit-factory inspection shall be stipulated by the manufacturer in the corporate product standard.

7.2 Type inspection

7.2.1 The type inspection shall be conducted in one of the following cases.

7.2.2 The number for type inspection is one. The inspection sample shall be extracted from the qualified batches in exit-factory inspection.

7.2.3 The items of type inspection are all requirements specified in this Standard.

8.1 Marks

8.1.1 Product mark

Each set of HIFU therapy system (or each part) shall be marked with the following information in an appropriate and eye-catching place.

8.1.3 Random document

8.1.3.1 When each HIFU therapy system exits factory, the following accompanying documents shall be included in the package.

8.2 Packaging

Packaging methods shall be specified by the manufacturer to ensure the safety of the product during normal transport, storage.

8.3 Transport

The transport method shall be specified by the contract. It nevertheless shall avoid rain and snow splashing and mechanical collision.

8.4 Storage

The warehouse for storage of HIFU therapy system shall be dry, well-ventilated, with an ambient temperature of -5°C ~ 40°C, a relative humidity less than 80%.