YY/T 0609-2018 English PDF (YYT0609-2018)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 0609-2018 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0609-2018
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 0609-2018: General specifications of medical diagnostic X-ray tube assemblies
YY/T 0609-2018
General specifications of medical diagnostic X-ray tube assemblies
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0609-2007
General technical requirements for medical diagnostic X-ray tube components
2018-11-07 release
2019-11-01 Implementation
Published by the State Drug Administration
Contents
Foreword I
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 Classification 1
5 Requirement 2
6 Test method 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0609-2007 "General technical conditions for medical diagnostic X-ray tube components."
Compared with YY/T 0609-2007, the main technical changes of this standard are as follows.
--- Reorganized the chapters and articles in the original standard;
--- This version uses the terms in GB/T 10149 and YY/T 0064-2016;
--- Added terms and definitions;
--- Increased external dimensions and wiring, marking, nominal X-ray tube voltage, dielectric strength of high voltage circuits, and nominal anode input power
Rate, nominal continuous input power, expected service life requirements and test methods;
--- Modified the description of the scope;
--- Modified the description of power conditions;
--- Modified the description of the focus of the X-ray tube assembly, and added the focus position and test method to the outside of the X-ray tube assembly;
--- Modified the description of sealing performance;
--- Modified the description and test method of X-ray tube assembly heat capacity safety device;
--- Modified the filtering description and test method of X-ray tube components;
--- Modified the description and test method of X-ray tube component leakage radiation. Removed leakage radiation during voltage regulation during loading
The requirements for leakage radiation in the radio and non-loaded state reduce the limit of leakage radiation to 0.88mGy/h;
--- Modified the description of high voltage cable connection;
--- Modified the description of appearance;
--- Modified the description of the random file;
--- Modified the description of environmental tests;
--- Added a note in the safety requirements that YY 0505 does not apply to X-ray tube assemblies.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is regulated by the National Technical Committee for Standardization of Medical Electrical Apparatus for Medical X-ray Equipment and Appliances (SAC /
TC10/SC1).
This standard was drafted. Siemens X-Ray Vacuum Technology (Wuxi) Co., Ltd., Liaoning Medical Device Inspection and Testing Institute, Hangzhou
Wandong Electronics Co., Ltd., Wenzhou Kangyuan Electronics Co., Ltd., Hangzhou Kailong Medical Equipment Co., Ltd., Zhuhai Ruineng Vacuum Electronics Co., Ltd.
the company.
The main drafters of this standard. Zhang Zhenneng, Huang Kelei, Cheng Dahai, Zhang Erping, Ding Kai, Tao Naibo.
The release of previous versions of this standard is.
--- YY/T 0609-2007.
General technical requirements for medical diagnostic X-ray tube components
1 Scope
This standard specifies the terms and definitions, classification, requirements, and tests of medical diagnostic X-ray tube assemblies (hereinafter referred to as X-ray tube assemblies).
method.
This standard applies to medical diagnostic X-ray tube components (including combined X-ray tube components), which are used for medical diagnostic X-ray equipment
Supporting the use of.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1804-2000 Tolerances for linear and angular dimensions without general tolerances
GB 9706.1 Medical electrical equipment. Part 1. General requirements for safety
GB 9706.11 Medical electrical equipment Part 2. Particular requirements for the safety of medical diagnostic X-ray source components and X-ray tube components
GB 9706.12 Medical electrical equipment Part 1. General requirements for safety III. Parallel standards. Radiation protection for diagnostic X-ray equipment
common enquiries
GB/T 10149 Medical X-ray equipment terms and symbols
GB/T 10151-2008 Technical requirements for high voltage cable plugs and sockets for medical diagnostic X-ray equipment
YY/T 0063 Medical electrical equipment focus characteristics of medical diagnostic X-ray tube assembly
YY/T 0064-2016 Electrical and load characteristics of medical diagnostic X-ray tube components (IEC 60613..2010, IDT)
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 0892-2013 Medical diagnostic X-ray tube assembly leak radiation test method
3 terms and definitions
The terms and definitions defined in GB/T 10149 and YY/T 0064-2016 as well as the following terms apply to this document.
3.1
Expected service life
The length of time that the ME equipment or ME system specified by the manufacturer is expected to remain safe to use (e.g., basic safety and basicity
can).
3.2
Integrated X-raytube assembly
The high-voltage transformer part of the high-voltage generator is integrated with the X-ray tube.
4 Classification
X-ray tube components are divided into.
a) fixed anode X-ray tube assembly;
b) rotating anode X-ray tube assembly;
c) Grid-controlled X-ray tube assembly.
5 Requirements
5.1 Working conditions
5.1.1 Environmental conditions
Unless otherwise specified in the instruction manual, the working environmental conditions of the X-ray tube assembly should meet.
a) Ambient temperature. 10 ℃ ~ 40 ℃;
b) Relative humidity. 30% ~ 75%;
c) Atmospheric pressure. 700hPa ~ 1060hPa.
5.1.2 Power conditions
Powered by a specific power source.
If applicable, the instruction manual shall give the requirements for the power supply.
5.2 Dimensions and wiring
5.2.1 Overall dimensions
The instruction manual should give the main dimensions of the X-ray tube assembly, and the unspecified tolerances of the dimensions should conform to GB/T 1804-2000
Level V regulations.
5.2.2 Wiring
The instruction manual should give the wiring diagram of the X-ray tube assembly.
5.3 Marking
The marking on the X-ray tube assembly should meet the requirements of "permanently attached" and "clearly identifiable" in GB 9706.1.
5.4 X-ray tube assembly focus
5.4.1 The focus position shall be marked on the outside of the X-ray tube assembly.
5.4.2 The X-ray tube assembly should be marked with a nominal focal value on the outside.
5.5 Nominal X-Ray Tube Voltage
5.5.1 Specified by the instruction manual.
5.5.2 The nominal X-ray tube voltage shall be marked on the outside of the X-ray tube assembly.
5.6 Dielectric Strength of High Voltage Circuits
The dielectric strength of the high-voltage circuit of the X-ray tube assembly should be able to withstand 1.1 times the nominal X-ray tube voltage, and there must be no abnormality for 3 minutes.
Discharge phenomena such as flashover and breakdown.
For example, the X-ray tube assembly is suitable for the perspective mode, and the nominal X-ray tube voltage in the perspective mode exceeds the nominal in the photography mode.
When the voltage of the X-ray tube is 80%, the dielectric strength of the high-voltage circuit of the X-ray tube assembly should also be able to withstand the nominal X-ray in 1.1 times the perspective mode
The voltage of the line tube shall not be abnormally discharged for 15 minutes, such as flashover and breakdown.
5.7 Nominal anode input power
5.7.1 Nominal photographic anode input power
Provided by the instruction manual.
5.7.2 Nominal CT anode input power
Provided by the instruction manual.
5.8 Nominal continuous input power
Provided by the instruction manual.
The nominal continuous input power includes the anode input power of the X-ray tube, the filament, the stator (if applicable), and other components in the X-ray tube assembly.
The power of any of his devices.
When the module is continuously loaded according to the nominal continuous input power until the module reaches thermal equilibrium, the temperature of the module shell should not exceed 85 ° C.
Unless otherwise specified, the ambient temperature should be between 20 ° C and 25 ° C.
5.9 Sealing performance
X-ray tube components should be sealed without leakage.
5.10 Thermal capacity safety device of X-ray tube assembly
The X-ray tube assembly should be equipped with a device that responds to a critical level of one or more thermal capacities, such as automatically detecting a predetermined
A device or analog computing device for the temperature level, volume, or pressure of the insulating medium inside the X-ray tube sleeve.
5.11 Filtration of X-ray tube components
The instruction manual should clarify the filtration of the X-ray tube assembly.The filtration of the X-ray tube assembly must comply with the following requirements.
--- X-ray tube components, except for the only ones that are suitable for mammography with a nominal X-ray tube voltage not exceeding 50kV,
The mass equivalent filtering of the X-ray beam shielding material in the tube assembly must meet the following requirements.
a) Non-removable materials in normal use, not less than 0.5mmAl;
b) all fixed additional filters must be removed with tools;
c) In special applications it should be stated in the instructions.
5.12 Leak radiation from X-ray tube components
When the X-ray tube assembly is loaded with the continuous anode input power at the nominal X-ray tube voltage, the leakage radiation at a distance of 1 m from the focus should not be
Over 0.88mGy/h.
5.13 High-voltage cable connection
Unless otherwise specified in the instruction manual, the basic dimensions of the connection part between the high-voltage cable socket and the plug shall comply with GB/T 10151-
4.1.1 requirements of.2008.
5.14 Expected life
The instruction manual should state the expected life of the X-ray tube assembly.
The expected service life should be expressed in years or months or loading times or kilowatt-seconds (kWs). CT tube components can be used in scan seconds (ss) or scan times.
Number representation.
If the expected service life is expressed in years or months, the basis should be given in the description.
5.15 Appearance
X-ray tube components should be neat, beautiful, flat and smooth surface, uniform color, and there should be no flaws, cracks and other defects.
5.16 Random files
5.16.1 The random files shall meet the requirements for the random files for X-ray tube components in GB 9706.11.
5.16.2 The random documents shall also state the rotational speed of the rotating anode, the single load rating, and the series load rating.
5.16.3 The CT tube assembly should also state the nominal CT scan power index in the random file.
5.17 Environmental test
Should meet the requirements of YY/T 0291.
5.18 Safety requirements
Should meet the requirements of standards GB 9706.1, GB 9706.11 and GB 9706.12.
Note. YY 0505 is not applicable to X-ray tube components.
6 Test method
6.1 Test conditions
Should comply with the provisions of 5.1.
6.2 Dimensions and wiring
6.2.1 Use vernier calipers or other general measuring tools to measure and visually inspect.
6.2.2 Check the random files.
6.3 Marking
Rub the mark with no excessive pressure by hand, first wipe with a cloth soaked in distilled water for 15s, and then wipe with a cloth soaked with 96% ethanol at room temperature
15s, and finally wipe with a cloth soaked with isopropyl alcohol for 15s;
After the test is completed, the marking shall be clearly legible. Pasted marks should not be loose or curled.
6.4 X-ray tube assembly focus
6.4.1 Check the external focus mark of the X-ray tube assembly.
6.4.2 Focus size shall be determined according to YY/T 0063.
6.5 Nominal X-ray tube voltage
6.5.1 Check random files.
6.5.2 Check the external marking of the X-ray tube assembly.
6.6 Dielectric Strength of High Voltage Circuits
The test voltage of the high-voltage circuit is loaded from 50% of the nominal X-ray tube voltage, and gradually rises to the specified test within 10s.
After the voltage value is checked, the X-ray tube assembly should have no abnormal discharge during the test.
In the dielectric strength test, the test voltage should be kept in the range of 100% to 105% of the required value and should be as close to 100% as possible.
The specified test voltage value.
During a dielectric strength test of a high voltage circuit, if a slight corona discharge occurs in the high voltage circuit,
The test conditions stop when the voltage refers to 100%, then this discharge phenomenon can be ignored.
6.7 Nominal anode input power
6.7.1 Nominal photographic anode input power
Check random files.
The nominal photographic anode input power can be tested for compliance with the following tests.
According to the nominal photographic anode input power at the X-ray tube voltage 100kV and the nominal X-ray tube voltage, according to YY/T 0064-2016
Regulations.
X-ray tube components with a nominal X-ray tube voltage below 100kV, according to YY/T 0064-2016 at the nominal X-ray tube voltage
Required.
The test duration is not less than 20min.
6.7.2 Nominal CT anode input power
Check random files.
The nominal CT anode input power can be tested for compliance with the following tests.
According to the nominal CT anode input power at the X-ray tube voltage of 120kV and the nominal X-ray tube voltage, according to YY/T 0064-2016
Regulations.
The test duration is not less than 2h.
6.8 Nominal continuous input power
Check random files.
When the component is continuously loaded at the nominal continuous input power until the component reaches thermal equilibrium, the temperature of the component case is measured.
6.9 Sealing performance
After carrying out the requireme...