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

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YY/T 0609-2018: General specifications of medical diagnostic X-ray tube assemblies
YY/T 0609-2018
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY/T 0609-2007
General specifications of medical diagnostic X-ray
tube assemblies
ISSUED ON: NOVEMBER 07, 2018
IMPLEMENTED ON: NOVEMBER 01, 2019
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Classification ... 6 
5 Requirements ... 6 
6 Test methods ... 10 
General specifications of medical diagnostic X-ray
tube assemblies
1 Scope
This Standard specifies the terms and definitions, classification, requirements
and test methods of medical diagnostic X-ray tube assemblies (hereinafter
referred to as the X-ray tube assemblies).
This Standard is applicable to medical diagnostic X-ray tube assemblies
(including integrated X-ray tube assembly). This product is for use with medical
diagnostic X-ray equipment.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 1804-2000, General Tolerances - Tolerances for Linear and Angular
Dimensions without Individual Tolerance Indications
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 X-ray source assemblies and X-ray tube assemblies for
medical diagnosis
GB 9706.12, Medical electrical equipment - Part 1: General requirements for
safety 3. collateral STANDARD: General requirements for radiation
protection in diagnostic X-ray equipment
GB/T 10149, Terminology and symbol for medical X-ray equipment
GB/T 10151-2008, Medical diagnostic X-ray equipment - Specifications for
high voltage cable plugs and sockets
YY/T 0063, Medical electrical equipment - X-ray tube assemblies for medical
diagnosis - Characteristics of focal spots
YY/T 0064-2016, Electrical and loading characteristics of X-ray tube
c) Atmospheric pressure: 700hPa~1060hPa.
5.1.2 Power conditions
It is 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 Dimensions
The instruction manual shall give the main dimensions of the X-ray tube
assemblies. The unmarked tolerances of the external dimensions shall meet
the requirements of Grade V in GB/T 1804-2000.
5.2.2 Wiring
The instruction manual shall give the wiring diagram of the X-ray tube
assemblies.
5.3 Marks
The marks on the X-ray tube assemblies shall meet the requirements of
"permanently attached" and "clearly identifiable" in GB 9706.1.
5.4 Focal point of the X-ray tube assemblies
5.4.1 The focal point position shall be marked on the outside of the X-ray tube
assemblies.
5.4.2 The nominal value of the focal point shall be marked on the outside of the
X-ray tube assemblies. The nominal value of focal point shall be the value
determined in accordance with YY/T 0063.
5.5 Nominal X-ray tube voltage
5.5.1 It is specified in the instruction manual.
5.5.2 The X-ray tube components shall be marked with the nominal X-ray tube
voltage on the outside.
5.6 Dielectric strength of high voltage circuits
The dielectric strength of high voltage circuit of the X-ray tube assemblies shall
be able to withstand 1.1 times the nominal X-ray tube voltage. There shall be
no abnormal discharge for 3min, such as flashover and breakdown.
- X-ray tube components, in addition to the ones that are only suitable for
mammography of which the nominal X-ray tube voltage is not exceeding
50kV, the mass-equivalent filtering of X-ray tube materials in the X-ray
tube components must meet the following requirements:
a) Non-removable material in normal use is not less than 0.5mmAl;
b) All fixed additional filters must be removed with tools;
c) In special applications it shall be stated in the instruction manual.
5.12 Leakage radiation of X-ray tube components
When the X-ray tube assemblies, according to continuous anode input power,
are loading in nominal X-ray tube voltage, the leakage radiation at 1m from the
focal point shall not exceed 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
meet the requirements of 4.1.1 in GB/T 10151-2008.
5.14 Expected service life
The instruction manual shall state the expected life of the X-ray tube assemblies.
The expected service life shall be expressed in years or months or loading times
or kilowatt-seconds (kW · s). The CT tube components can be expressed in
scan seconds (ss) or scan times.
If the expected service life is expressed in years or months, the basis shall be
given in the instruction manual.
5.15 Appearance
The X-ray tube components shall be neat, beautiful, flat, smooth and uniform in
color. There must be no defects such as scars and cracks.
5.16 Accompanying documents
5.16.1 The accompanying documents shall meet the requirements for
accompanying documents for X-ray tube components in GB 9706.11.
5.16.2 The accompanying documents shall also state the speed of the rotating
anode, the single load quota, the series load quota.
5.16.3 The CT tube assemblies shall also specify the nominal CT scan power
index in the accompanying documents.
The test voltage of the high voltage circuit is loaded from 50% of the nominal
X-ray tube voltage. Start timing after it gradually rises to the specified test
voltage value within 10s. The X-ray tube assemblies shall have no abnormal
discharge during the test.
In the dielectric strength test, the test voltage shall be kept within the range of
100%~105% of the required value. And it shall be as close as possible to the
specified test voltage value of 100%.
During the dielectric strength test of high voltage circuits, if a slight corona
discharge occurs in a high-voltage circuit but stops when the test voltage drops
to 100% of the voltage indicated by the test conditions, then, this discharge
phenomenon can be ignored.
6.7 Nominal anode input power
6.7.1 Nominal photographic anode input power
Check the accompanying documents.
The nominal photographic anode input power can be tested for the compliance
with the following tests:
According to the nominal photographic anode input power at the X-ray tube
voltage of 100kV and the nominal X-ray tube voltage, it is carried out according
to the provisions of YY/T 0064-2016;
The X-ray tube components of which the nominal X-ray tube voltage is below
100kV shall be carried out at the nominal X-ray tube voltage in accordance with
the provisions of YY/T 0064-2016;
The test duration is not less than 20min.
6.7.2 Nominal CT anode input power
Check the accompanying documents.
The nominal CT anode input power can be tested for the 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, it is carried out according to the
provisions of YY/T 0064-2016.
The test duration is not less than 2h.
6.8 Nominal continuous input power
...