YY/T 1750-2020 PDF in English
YY/T 1750-2020 (YY/T1750-2020, YYT 1750-2020, YYT1750-2020)
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Ultrasonic surgical equipment for soft tissue excision and hemostasia
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Standards related to (historical): YY/T 1750-2020
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YY/T 1750-2020: PDF in English (YYT 1750-2020) YY/T 1750-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 41
Ultrasonic surgical equipment for soft tissue excision and
hemostasia
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 8
Ultrasonic surgical equipment for soft tissue excision and
hemostasia
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.
4.5 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.
4.10 Use functions
The equipment shall have the use functions specified by the manufacturer in the
accompanying documents.
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.
5.3 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.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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