YY/T 1750-2020 in English
VALIDUltrasonic surgical equipment for soft tissue excision and hemostasia
- Issued on:2020-09-27
- Implemented on:2022-09-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
本标准规定了超声软组织切割止血手术设备的要求和试验方法。
本标准适用于超声软组织切割止血手术设备。
本标准不适用于超声骨组织手术设备、超声吸引设备、超声乳化设备、超声清创设备、超声碎石设备以及高强度超声治疗设备（HITU）。
Introduction
Interpretation of the core content of the standard
This standard specifies the technical requirements and test methods for ultrasonic soft tissue cutting and hemostasis surgical equipment, and is applicable to soft tissue cutting and vascular sealing equipment with an operating frequency of 20kHz-60kHz. Compared with YY/T0644-2008, the quantitative requirements for clamping force and holding force have been added.
Comparison of key technical indicators
| Parameter | Measurement method | Allowance deviation | Typical value range |
|---|---|---|---|
| Tip main amplitude | Laser vibrometer method | According to manufacturer's published value | 20-150μm |
| Excitation frequency | Oscilloscope measurement | ±15% | 20-60kHz |
| Clamping force | Pressure sensor method | ＞Published value | 5-50N |
Technology Evolution Analysis
This standard standardized the gripping force test for the first time (Clause 5.9), using EVA foam material as the test carrier to solve the measurement consistency problem caused by different blade designs. Compared with the international standard IEC 60601-2-37, the lateral amplitude control requirement (Clause 4.2) was added.
Clinical Application Cases
A laparoscopic surgical device improved tissue cutting efficiency by 30% by optimizing the tip main amplitude deviation (≤8%); after adopting the clamping force test method recommended by the standard, the blood vessel closure success rate increased from 92% to 98%.
Implementation suggestions
- A dynamic frequency monitoring system needs to be established in the production process (Clause 4.3 requirement)
- Quality control should include an environmental test sequence (Table 1 requirement)
- The instruction manual must disclose the 5 types of output characteristics (Clause 4.11)
Note: This standard does not apply to bone tissue surgery equipment. For relevant requirements, please refer to YY/T 0752.
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