YY/T 1601-2018 English PDF (YYT1601-2018)

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YY/T 1601-2018: Ultrasonic surgical equipment for osseous tissue
YY/T 1601-2018
Ultrasonic surgical equipment for osseous tissue
ICS 11.040.60
C41
People's Republic of China Pharmaceutical Industry Standard
Ultrasonic bone tissue surgery equipment
2018-01-19 released
2019-01-01 Implementation
Issued by the State Food and Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Technical requirements 1
5 Test method 3
6 Inspection rules 4
7 Logo and instruction manual 5
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee Medical Ultrasonic Equipment Subcommittee (SAC/TC10/SC2).
Drafting organizations of this standard. Hubei Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration, Jiangsu Shuimu Canopy Technology
Limited company.
The main drafters of this standard. Jiang Shilin, Cao Qun, Wang Zhijian, Liu Qingming.
Ultrasonic bone tissue surgery equipment
1 Scope
This standard specifies the technical requirements, test methods, inspection rules, signs and use of ultrasonic bone tissue surgery equipment (hereinafter referred to as equipment)
Instructions.
This standard applies to ultrasound bone tissue surgery equipment.
This standard does not apply to ultrasonic cleaning equipment that removes plaque and stones on teeth.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191-2008 Graphical signs for packaging, storage and transportation
GB 9706.1-2007 Medical electrical equipment Part 1.General requirements for safety
GB/T 9969-2008 General Rules for the Use of Industrial Products
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
YY/T 0644-2008 Measurement and publication of the basic output characteristics of ultrasonic surgical systems
3 Terms and definitions
The following terms and definitions defined in YY/T 0644-2008 apply to this document.
3.1
Surgical equipment powered by ultrasound, the frequency is generally 20kHz ~ 60kHz, suitable for bone tissue, as well as teeth, bone substitutes
Cutting, shaping, crushing, etc.
4 Technical requirements
4.1 Appearance and structure
4.1.1 The enclosure of the equipment should be free from mechanical damage and corrosion, and the text and logo on the panel should be firm and clearly visible.
4.1.2 The plastic parts of the equipment should be free from blistering, cracking, deformation and overflow of the filling material.
4.1.3 The operation and adjustment mechanism of the equipment should be flexible and reliable, and the fasteners should not be loosened.
4.1.4 There should be no leakage in the liquid pipeline.
4.2 Display and control
The equipment shall have the setting, control, display and/or indication of the functional status, and the output parameters can be set or adjusted.
4.3 Tip main amplitude
The manufacturer shall announce the main amplitude of the tip of the treatment head. The deviation is announced by the manufacturer.
4.4 Tip transverse amplitude
If applicable, the manufacturer shall announce the tip transverse amplitude of the tip of the treatment head. The deviation is announced by the manufacturer.
Note. The tip transverse amplitude can also be designed to participate in the cutting of bone tissue.
4.5 Excitation frequency
The manufacturer shall publish the excitation frequency of each ultrasonic hand-held component, and its error shall not exceed ± 15%.
4.6 Tip vibration frequency
The manufacturer shall publish each type of tip vibration frequency of each ultrasonic hand-held component, and the error shall not exceed ± 15%.
4.7 Exported output sound power
The derived output sound power of each type of tip of each ultrasonic handheld component should be within the range announced by the manufacturer.
4.8 Duty Cycle
If the main amplitude of the tip is modulated, its duty cycle or duty cycle range should conform to the manufacturer’s published value.
4.9 Static (no-load) electric power
The measured static (no-load) electric power should be less than the maximum static (no-load) electric power of each ultrasonic handheld component announced by the manufacturer.
4.10 Maximum electric power
The measured maximum electrical power should be less than the maximum electrical power value of each ultrasonic handheld component announced by the manufacturer.
4.11 Power reserve index
The power reserve index should conform to the value announced by the manufacturer.
4.12 Main sound output area
If applicable, the main sound output area of each type of tip should comply with the manufacturer's published value.
4.13 Secondary transverse vibration sound output area
If applicable, the secondary lateral vibration sound output area of each type of tip should comply with the manufacturer's published value.
4.14 Liquid flow
The manufacturer shall announce the adjustment range of the liquid flow rate, and the error of the liquid flow rate relative to the nominal value shall not exceed ±10%.
4.15 Noise
Should not be greater than 90dB (A weighting).
4.16 Features to be published in the specification
a) The main amplitude of the tip of the treatment head;
b) The main sound output area at the tip of the treatment head;
c) The excitation frequency of the ultrasonic hand-held parts;
d) The output sound power derived from the tip of the treatment head;
e) Type of system frequency control;
f) The power reserve index corresponding to the main amplitude state of the reference tip under the combination of ultrasonic hand-held parts/treatment head tip.
4.17 Safety requirements
The safety requirements should meet the requirements of GB 9706.1-2007.
4.18 Environmental test
The environmental test of the equipment should be carried out in accordance with the regulations in GB/T 14710-2009, and the manufacturer should specify the climate environment in the product standard.
The group of environmental test and the group of mechanical environmental test, and stipulate the initial test, intermediate test or final test item of the test.
5 Test method
5.1 Appearance and structure
Visually observe and operate the inspection, it should meet the requirements of 4.1.
5.2 Display and control
Visually observe and operate the inspection, it should meet the requirements of 4.2.
5.3 Tip main amplitude
Measure according to the method specified in 6.1 of YY/T 0644-2008, which should meet the requirements of 4.3.
Deviation = (measured value-published value)/published value
5.4 Tip transverse amplitude
Measure according to the method specified in 6.2 of YY/T 0644-2008, which should meet the requirements of 4.4.
Deviation = (measured value-published value)/published value
5.5 Excitation frequency
Measure according to the method specified in 6.3.1 of YY/T 0644-2008, and the result should meet the requirements of 4.5.
5.6 Tip vibration frequency
Measure according to the method specified in 6.4 of YY/T 0644-2008, and the result should meet the requirements of 4.6.
5.7 Exported output sound power
Measure according to the method specified in 6.5.1 of YY/T 0644-2008, and the result should meet the requirements of 4.7.
5.8 Duty Cycle
Measure according to the method specified in 6.8 of YY/T 0644-2008.The result should meet the requirements of 4.8.
5.9 Static (no-load) electric power
Measure according to the method specified in 6.9 in YY/T 0644-2008, and the result shall not exceed the published value.
5.10 Maximum electric power
Measure according to the method specified in 6.10 of YY/T 0644-2008, and the result shall not exceed the published value.
Note. The simulated tip load can use bone approximation, such as phenolic plastic.
5.11 Power reserve index
According to the results of 5.9 and 5.10, calculate the power reserve index according to the method specified in 6.13 of YY/T 0644-2008.
5.12 Main sound output area
Calculate according to the definition in 3.9 of YY/T 0644-2008 and refer to the method specified in 6.11 of YY/T 0644-2008.
5.13 Secondary transverse vibration sound output area
Calculate according to the definition in 3.15 of YY/T 0644-2008 and refer to the method specified in 6.12 of YY/T 0644-2008.
5.14 Liquid flow
Consult the manufacturer's accompanying documents. According to the manufacturer's regulations, measure the flow of liquid in the liquid pipeline, such as flow control
Measure the flow at the highest, middle, and lowest gears; if the flow control is continuous control, measure the flow at 20%, 50%, and 80%.
The deviation of the value from the nominal value shall comply with the provisions of 4.14.
5.15 Noise
Put the equipment in the normal loading state specified by the manufacturer, and use a sound level meter (A weighting) at a distance of 1m from the front, back, left and right of the ultrasonic handle
Measure the noise value separately, and the result should meet the requirements of 4.15.
Note. The normal loading state refers to the simulated tip load based on the actual use of the equipment.
5.16 Features to be published in the specification
Check relevant documents to verify compliance with 4.18.
5.17 Safety requirements
Check whether it meets the requirements according to the method specified in GB 9706.1-2007.
5.18 Environmental test
Test according to the requirements specified in GB/T 14710-2009.
6 Inspection rules
6.1 Equipment inspection is divided into factory inspection and type inspection.
6.2 The number of samples, inspection items, and judgment rules for factory inspection shall be specified by the manufacturer in the enterprise standards.
6.3 Type inspection
6.3.1 Type inspection shall be carried out in one of the following situations.
a) Registration inspection;
b) When major changes in design, process or materials may cause changes in the safety or performance of the equipment;
c) When requested by the national quality supervision department.
6.3.2 Type inspection items.
All requirements specified in this standard. The number of samples for type testing is one.
6.3.3 Qualified judgment of type test.
In the inspection items, if there are items that do not meet the requirements, the unqualified items are allowed to be repaired. After adjustment and repair, it may be inconsistent with
All items related to the grid must meet the requirements in the retest, otherwise it will be deemed unqualified.
The inspection items and determination rules for quality supervision and inspection shall be separately formulated by the quality supervision agency.
7 Logo and instruction manual
7.1 Sign
7.1.1 The following signs should be displayed on the equipment.
a) The name of the manufacturer;
b) Product name and model;
c) Use power;
d) Production date or factory number;
e) Other signs required by applicable standards and regulations.
7.1.2 The following signs should be on the packing box.
a) The name and address of the manufacturer;
b) Product name, model, quantity;
c) Weight and volume (length × width × height);
d) "Fragile items", "upward", "fear of rain" and other words or signs, the text and graphics should comply with the relevant requirements of GB/T 191-2008
Regulations;
e) Other signs required by applicable standards and regulations.
7.2 Random files
When each device leaves the factory, the packaging box should include the following random documents.
a) Packing list, random spare parts and/or accessories list;
b) Certificate of conformity;
c) Instructions for use.
7.3 Manual
The instruction manual should be able to guide users in the correct operation and maintenance, and comply with GB/T 9969-2008 and other relevant regulations and standards.