YY/T 0752-2016 English PDF (YY/T0752-2016)

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YY/T 0752-2016: Electrical surgical equipment for osseous tissue
YY/T 0752-2016
Electrical surgical equipment for osseous tissue
ICS 11.040.30
C35
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0752-2009
Electric bone tissue surgery equipment
Released on.2016-01-26
2017-01-01 Implementation
Issued by the State Food and Drug Administration
Table of contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Product Category 2
5 Technical requirements 2
6 Test method 3
Electric bone tissue surgery equipment
1 Scope
This standard specifies the terms and definitions, product classification, technical requirements, and test methods of electric bone tissue surgery equipment.
This standard applies to electric bone tissue surgery equipment (hereinafter referred to as equipment) powered by a network power supply.
This standard does not apply to bone tissue surgery equipment powered by an internal power source.
This standard does not apply to similar dental equipment.
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 reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1-2007 Medical electrical equipment Part 1.General requirements for safety (IEC 60601-1.1988, IDT)
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
YY/T 0149-2006 Stainless steel medical equipment corrosion resistance test method (ISO 13402.1995, MOD)
YY 0505-2012 Medical electrical equipment Part 1~2.General safety requirements Parallel standard electromagnetic compatibility requirements and testing
Inspection (IEC 60601-1-2.2004, IDT)
YY 1057-2016 General technical conditions for medical foot switches
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Electric bone tissue surgery equipment electricsurgical equipmentforosseoustissue
It is powered by a network power source and provides the mechanical power required by the surgical tool to perform bone tissue surgery.
3.2
Host (controller) mainframe
Electric bone tissue surgery equipment provides mechanical kinetic energy and/or electrical energy for mobile phones, and implements real-time monitoring of its output.
3.3
Flexiblecable
The component that realizes the transmission of mechanical kinetic energy between the host and the mobile phone.
3.4
Cable
The component that realizes the electrical connection between the host and the mobile phone.
3.5
Mobile phone handpiece
The mobile phone is a component that is held by the operator and can drive the clamped surgical knife to achieve the purpose of surgery. The mobile phone can be integrated or split.
The split type is composed of a (power) handle that can provide power to the machine head, a machine head that clamps the tool, and (or) a variable speed and direction changing mechanism.
3.6
Cutter
An instrument that is clamped on a mobile phone to perform bone tissue surgery.
3.7
Rotationspeed/frequencyofwork
Within the maximum output speed/frequency range of the mobile phone output specified by the manufacturer, the corresponding output speed/frequency under a specific workload.
3.8
Loadofwork
The torque and/or force specified by the manufacturer that can sustain a specific working speed/frequency.
4 Product Classification
The classification according to the connection mode of the host and the mobile phone is as follows.
a) Flexible shaft type;
b) Cable type;
c) Mixed type.
5 Technical requirements
5.1 Basic requirements
5.1.1 When the equipment has multiple working states, there should be an indication of the current working state.
5.1.2 The allowable error of the set speed/frequency and no-load speed/frequency is.
a) When the set speed/frequency≤3000r/min(c/min), the error should be within ±15%;
b) When 3000r/min(c/min)< set speed/frequency≤30000r/min(c/min), the error should be within ±10%;
c) When the set speed/frequency>30000r/min(c/min), the error should be within ±8%.
5.1.3 The allowable error between the rotational speed at a specific working load point set by the manufacturer and the rotational speed measured at that point is.
a) When the set speed is less than or equal to 3000r/min, the error should be within ±15%;
b) When 3000r/min< set speed≤30000r/min, the error should be within ±10%;
c) When the set speed>30000r/min, the error should be within ±8%.
5.1.4 The corrosion resistance of the stainless steel products of some parts of the equipment application should meet the 5.4b requirements of YY/T 0149-2006.
5.1.5 According to the conditions of use, the noise should not exceed the following requirements. rotating mobile phones 75dB (A), non-rotating mobile phones 90dB (A).
5.2 Mobile phone performance requirements
5.2.1 The clamping of the tool by the mobile phone should meet the following requirements.
a) When a 30N tensile force is applied in the axial direction, no slippage phenomenon can occur;
b) The mobile phone holding part should not slip or be permanently deformed under the 1.5 times the maximum working load claimed by the manufacturer.
5.2.2 The tool should be easy to install and unload. If there are auxiliary installation tools, the requirements for use should be stated in the manual.
5.2.3 The radial circle runout output by the mobile phone of the rotary motion category shall meet the following requirements.
a) When the set speed is less than or equal to 3000r/min, it is not more than 0.20mm;
b) When 3000r/min< set speed ≤30000r/min, not more than 0.10mm;
c) When the set speed>30000r/min, it is not more than 0.08mm.
5.2.4 The axial movement between the tool and the chuck should not be greater than 0.5mm.
5.2.5 Under rated working conditions, the accessible shell surface temperature should not exceed the ambient temperature by 20°C.
5.2.6 The surface roughness of the smooth metal surface is Ra≤1.6μm (without sandblasted surface), and there must be no sharp edges, burrs, or sharp corners.
5.3 Performance requirements for flexible shafts and connectors
5.3.1 The length is not less than 1800mm.
5.3.2 The loading and unloading between the flexible shaft and the host, and between the flexible shaft and the mobile phone shall not require the aid of accessory tools, and the axial pulling force of 30N shall not slip off.
5.3.3 The minimum bending radius for normal operation should be less than or equal to 120mm, and the flexible shaft should not be twisted or shaken when it reaches the overload protection.
5.4 Performance requirements of cables and connectors
5.4.1 The length should not be less than 1800mm.
5.4.2 The connection with the mobile phone and the host should be reliable, and the axial pulling force of not less than 20N should not slip off.
5.5 Foot controller requirements
5.5.1 It shall meet the requirements of YY 1057-2016.
5.5.2 The connection between the pedal cable and the host should be convenient and reliable. A tensile force of not less than 20N applied in the axial direction shall not slip off.
5.6 Environmental test requirements
It should meet the requirements of GB/T 14710-2009, and the requirements of test group II (except for special circumstances) should be adopted.
5.7 Safety requirements
Should meet the requirements of GB 9706.1-2007 and YY 0505-2012.
The degree of protection against electric shock of the equipment should meet the requirements of the F-type application part.
6 Test method
6.1 Basic test
6.1.1 The inspection and operation verification of the equipment according to the instructions shall meet the requirements of 5.1.1.
6.1.2 Test according to the following steps.
a) After the mobile phone is connected to the host, fix the mobile phone on the test platform;
b) Connect the output terminal of the mobile phone to the test device (dynamometer or other dynamometer) through the test rod;
c) When detecting the output speed/frequency of equipment with preset speed, at least three points shall be taken, including the minimum setting value, the maximum setting value and the approximate value of the two.
The value of the intermediate point (it is recommended to set a detection point in each segment); detect the only preset speed/frequency equipment no-load output speed/
In the case of frequency, take the preset point for testing.
Measure the speed/frequency of the mobile phone running without load, record it as ni, and record the corresponding set speed/frequency of the device at the same time, record it as Ni,
Each measurement value should meet the requirements of formula (1).
ni-Ni
Ni ×
100% ≤5.1.2 specified requirements (1)
Where.
Ni---set speed/frequency (r/min, c/min);
ni ---Measured no-load speed/frequency (r/min, c/min).
6.1.3 Test according to the following steps.
a) Operate according to 6.1.2a) and 6.1.2b);
b) According to the working speed in each speed range required by 5.1.2, set a specific range provided by the manufacturer
The rotational speed of the working load point is denoted as N';
c) Detect the steady-state speed when gradually loaded to the specific load point, denoted as n'.
The measured value should meet the requirements of formula (2).
n'-N'
N'×100% ≤5.1.3
Prescribed requirements (2)
Where.
N'---speed at a specific working load point (r/min);
n'---Measured speed (r/min) at a specific working load point.
6.1.4 Perform the test evaluation in accordance with the test method in YY/T 0149-2006, and the stainless steel products of the applied part of the equipment should comply with
The requirements specified in YY/T 0149-2006 5.4b.
6.1.5 Place the mobile phone close to the host and load the test rod or tool with the largest specification, and fix it at a height of about 1.2m from the ground. The device is set according to the manual
Maximum speed/frequency no-load operation, use a sound level meter (A-weighted) to measure the noise value at a distance of 1m from the front, back, left, and right of the mobile phone, and measure the final result.
The fruit value should not be greater than the requirements of 5.1.5.
6.2 Performance test of mobile phone
6.2.1 Test according to the following steps.
a) Clamp the test rod or tool to the mobile phone, then fix the mobile phone on the measuring platform, and apply a 30N axial tension to the test
Test on the rod or tool, the test rod or tool should not fall off;
b) Clamp the test rod or tool with the largest specification to the mobile phone, then fix the mobile phone on the measuring platform, and place the test rod or tool on the
Gradually load to 1.5 times the rated load, there should be no relative slippage or permanent deformation between the test rod or tool and the chuck.
6.2.2 Carry out the loading and unloading test of the test rod or tool and the mobile phone according to the instructions, which should meet the requirements of 5.2.2.
6.2.3 Clamp the test rod or tool to the mobile phone, then fix the mobile phone on the test platform, and keep the test rod or tool with the test platform.
parallel.
a) When the set speed is less than or equal to 3000r/min, the equipment is running at low speed and no-load. After the speed is stable, use a dial indicator to measure and record the test rod or
The radial runout of the tool at 20mm from the output end of the mobile phone is measured 3 times, and the arithmetic mean value should meet the requirements of 5.2.3.
b) When the set speed>3000r/min, run at no-load within the recommended speed range, after the speed is stable, use a non-contact measuring instrument
Measure the radial circular runout of the test rod or tool 20mm away from the output end of the mobile phone, measure 3 times, and the arithmetic mean value should match
Meet the requirements of 5.2.3.
6.2.4 Install a test rod or cutter on the output end of the mobile phone, fix the mobile phone on the test platform, and apply a 10N axial direction on the test rod or cutter.
Push-pull force. Using a dial indicator to measure the relative displacement between the test rod or tool and the cell phone chuck should meet the requirements of 5.2.4.
6.2.5 Load the maximum specification test rod or tool at the maximum speed according to the manufacturer's instructions to run the mobile phone without load. The measurement can be reached after 3min
The maximum temperature on the surface of the phone case. The test is carried out at an ambient temperature of 20°C ± 2°C.
6.2.6 The surface roughness is measured by the sample block comparison method or the electrical measurement method, and the electrical measurement method is used for the arbitration.
Hand feel inspection, no sharp edges, burrs, sharp corners.
6.3 Flexible shaft performance test
6.3.1 Measuring the length of the flexible shaft should meet the requirements of 5.3.1.
6.3.2 Load and unload the flexible shaft according to the method specified in the manual, and apply 30N axially on the connection end of the flexible shaft and the host and the connection end of the flexible shaft and the mobile phone.
The pulling force should meet the requirements of 5.3.2.
6.3.3 Test according to the following steps.
a) After the flexible shaft is connected to the host, fix the output end of the flexible shaft on the test platform;
b) Connect the output end of the flexible shaft to the test device through the connector, and set the output speed/frequency of the equipment at the highest value.
Run; put the flexible shaft under the natural bending shape during normal operation, and then adjust the distance between the test device and the host until it is soft.
One of the curved parts of the shaft has a radius of curvature that reaches the minimum radius specified by the standard;
c) Gradually load until the equipment reaches the overload protection, it should meet the requirements of 5.3.3.
6.4 Connecting cable test
6.4.1 Measuring the cable length should meet the requirements of 5.4.1.
6.4.2 Apply an axial pulling force of 20N on the cable connecting the cable to the host and the cable connecting to the mobile phone, which should meet the requirements of 5.4.2
Require.
6.5 Foot controller test
6.5.1 Car...