YY/T 1750-2020Ultrasonic surgical equipment for soft tissue excision and hemostasia (English PDF)
超声软组织切割止血手术设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 27, 2020
Implementation date
September 1, 2022
Scope
YY/T 1750-2020 is the English-translated version of 超声软组织切割止血手术设备.
YY/T 1750-2020 is the Chinese pharmaceutical industry standard for ultrasonic surgical equipment used to cut soft tissue and to seal vessels, the ultrasonic scalpel systems.
It sets the requirements and the test methods, covering the frequency and amplitude of the transducer, the power delivered and its stability, the cutting and haemostatic performance, the temperature reached by the blade, the handpiece and its accessories, the alarms and the safety and electromagnetic compatibility by reference to the general standards. Issued on 27 September 2020, it has applied since 1 September 2022.
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Document preview — YY/T 1750-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions4
- 4 Requirements5
- 5 Test methods8
1 Scope
This Standard specifies the requirements and test methods for ultrasonic surgical equipment for soft tissue excision and hemostasia (hereinafter referred to as equipment).
This Standard applies to ultrasonic surgical equipment for soft tissue excision and hemostasia.
This Standard does not apply to ultrasonic surgical equipment for bone tissue, ultrasonic suction equipment, phacoemulsification equipment, ultrasonic debridement equipment, ultrasonic lithotripsy equipment, and high-intensity ultrasonic therapeutic equipment (HITU).
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
YY/T 0644-2008 Ultrasonics-surgical systems - Measurement and declaration of the basic output characteristics
YY 1057 General specifications for medical foot switch
YY/T 1420 Environmental requirement and test methods for medical ultrasonic equipment
3 Terms and definitions
The terms and definitions defined in YY/T 0644-2008 and the following ones apply to this document.
The maximum output sound power, derived from each cutter head of each ultrasonic hand-held part, shall comply with the requirements published by the manufacturer.
4 Requirements
4.10 Use functions The equipment shall have the use functions specified by the manufacturer in the accompanying documents.
4.5 Static electric power
The static electric power of each ultrasonic hand-held part and its deviation shall comply with the requirements published by the manufacturer.
4.6 Maximum electric power
The maximum electric power of each ultrasonic hand-held part and its deviation shall comply with the requirements published by the manufacturer.
4.7 Clamping force
The maximum clamping force for each tip of each ultrasonic hand-held part shall be greater than the minimum limit published by the manufacturer.
4.8 Grasping force
The grasping force of each cutter head of each ultrasonic hand-held part with grasping function shall be greater than the value published by the manufacturer.
4.9 Appearance and structure
4.9.1 The surface of the equipment shall be clean and free from scratches, cracks and other defects.
4.9.2 The text and signs indicating the operation shall be clear, easy to recognize, and durable.
4.9.3 The control and adjustment mechanism shall be flexible and reliable. The fastening parts shall not be loose.
Note: This article does not involve product design parameters or function items that cannot be verified by intuitive test methods.
4.11 Declaration of output characteristics
The following characteristics shall be declared in the accompanying documents:
a) The reference tip principal amplitude of each type of cutter head tip (i.e. the maximum tip principal amplitude); T - Declared value or nominal value. Deviation is usually expressed as a percentage.
5 Test methods
5.3 Lateral amplitude of tip
According to the method specified in 6.2 of YY/T 0644-2008, measure the maximum lateral amplitude of the tip of cutter head. It is also possible to use the laser vibrometer method specified in 6.1.2 of YY/T 0644-2008 to measure.
According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value.
5.4 Excitation frequency
Measure according to the method specified in 6.3 of YY/T 0644-2008. It is also possible to use an oscilloscope to measure.
According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value.
5.5 Derived output sound power
Measure according to the method specified in 6.5.1 of YY/T 0644-2008.
5.6 Static electric power
Measure according to the method specified in 6.9 of YY/T 0644-2008.
According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value.
5.7 Maximum electric power
Measure according to the method specified in 6.10 of YY/T 0644-2008.
According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value.
5.8 Clamping force
Set a pressure sensor at the tip of cutter head. Its clamping position is specified by the manufacturer. Set the equipment in the state of maximum clamping force. Read the value of the pressure sensor. Repeat 5 times. Take the average value as the maximum clamping force.
The test results shall indicate the geometrical position at which the maximum clamping force occurs.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY/T 0644-2008Ultrasonics- surgical systems - Measurement and declaration of the basic output characteristics
- YY 1057General specifications for medical foot switches
- YY/T 1420Environmental requirement and test methods for medical ultrasonic equipment
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
YY 1057-2016 — General specifications for medical foot switches
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