YY/T 0106-2021 (YY/T0106-2021, YYT 0106-2021, YYT0106-2021)
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(General technical conditions of medical diagnostic X-needle machine)
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YY/T 0106-2021
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Standards related to: YY/T 0106-2021
| Standard ID | YY/T 0106-2021 (YY/T0106-2021) | | Description (Translated English) | (General technical conditions of medical diagnostic X-needle machine) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 17,114 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2022-09-01 | | Summary | This standard specifies the classification and composition, requirements and test methods of medical diagnostic X-ray machines. This standard applies to medical diagnostic X-ray machines. For medical diagnostic X-ray machines that have national or industry-specific standards, the corresponding national or industry-specific standards should be implemented at the same time. This standard does not apply to X-ray computed tomography equipment. | YY/T 0106-2021
(General technical conditions of medical diagnostic X-needle machine)
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0106-2008
General technical conditions for medical diagnostic X-ray machines
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 1
5 Requirements 2
6 Test method 7
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0106-2008 "General Technical Conditions for Medical Diagnostic X-ray Machines". Compared with YY/T 0106-2008
The technical changes are as follows.
--- Modified the scope of application of this standard, and changed the corresponding national or industry-specific standards that should be implemented to the corresponding national standards that should be implemented at the same time.
or industry-specific standards (see Chapter 1, Chapter 1 of the.2008 edition);
--- Modified the nominal electrical power and added the description of the mammary X-ray machine (see 5.2.2, 5.2.2 of the.2008 edition);
--- Modified the description of the deviation value of the loading factor in the loading factor and control (see 5.3, 5.3 of the.2008 edition);
--- Increased the requirements and test methods for automatic exposure control (see 5.3.6, 6.3.6);
--- Modified the description of 5.4.1a)~d) [see 5.4.1a)~d), 5.4.1 of the.2008 edition];
--- Added 5.4.1e) artifacts and test methods [see 5.4.1e), 6.4.1];
--- Modified the description of 5.4.2b) [see 5.4.2b), 5.4.2b) of the.2008 edition];
--- Delete the description of 5.4.2c), and modify d) to c) [see 5.4.2c), 5.4.2c) and d) of the.2008 edition];
--- Increased requirements and test methods for three-dimensional imaging performance (see 5.4.3, 6.4.3);
--- Increased the requirements and test methods for quantum detection efficiency (see 5.4.4, 6.4.4);
--- Increased radiation safety requirements and test methods (see 5.5, 6.5);
--- Increased the requirements and test methods for pediatric examinations (see 5.6, 6.6);
--- Modified the mechanical device performance clause number, and modified the description of other requirements except 5.7.5 and 5.7.7 (see 5.7,.2008
5.5 of the year edition);
--- Deleted the software function, and added the requirements and methods of 5.8 network and software (see 5.8 for requirements and 6.8 for test methods,.2008
version 5.6 and 6.6);
--- Deleted high-voltage cable plugs and sockets (see 5.8 of the.2008 edition);
--- Increased the requirements and test methods of the accompanying documents (see 5.10, 6.10);
--- Increased the requirements and test methods of the display system (see 5.11, 6.11);
--- Modified the clause number of the environmental test (see 5.13, 5.10 of the.2008 edition);
--- Modified the security clause number (see 5.14, 5.11 of the.2008 edition).
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/SC
1) Focal point.
This standard was drafted by. Liaoning Provincial Medical Device Inspection and Testing Institute, Medical Device Technology Review Center of the State Drug Administration, Ximen
Sub-Medical System Co., Ltd., Shanghai United Imaging Medical Technology Co., Ltd.
The main drafters of this standard. Zhang Yong, Sun Zhiyong, Zhang Qing, Qian Chunjian, Liu Jiong, Xu Xiaobin, Huang Kelei, Jin Ye.
The previous editions of the standard replaced by this standard are as follows.
---YY/T 0106-1993, YY/T 0106-2004, YY/T 0106-2008.
General technical conditions for medical diagnostic X-ray machines
1 Scope
This standard specifies the classification and composition, requirements and test methods of medical diagnostic X-ray machines.
This standard applies to medical diagnostic X-ray machines. For medical diagnostic X-ray machines with national or industry-specific standards, the
Implement the corresponding national or industry-specific standards.
This standard does not apply to X-ray computed tomography equipment.
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 edition (including all amendments) applies to this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Safety
GB 9706.3 Medical Electrical Equipment Part 2.Safety Special Requirements for High Voltage Generators of Diagnostic X-ray Generators
GB 9706.11 Medical electrical equipment Part 2.Special requirements for the safety of medical diagnostic X-ray source assemblies and X-ray tube assemblies
GB 9706.12 Medical Electrical Equipment Part 1.General Requirements for Safety III. Radiation Protection of Parallel Standard Diagnostic X-ray Equipment
common enquiries
GB 9706.14 Medical Electrical Equipment Part 2.Special Requirements for the Safety of Auxiliary Equipment of X-ray Equipment
GB 9706.23 Medical Electrical Equipment Part 2-43.Special Requirements for the Safety of Interventional X-ray Equipment
GB 9706.24 Medical Electrical Equipment Part 2-45.Mammography Equipment and Mammography Stereotaxic Device Safety
with request
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
GB/T 19042.1 Evaluation and Routine Tests of the Medical Imaging Department Part 3-1.X-rays for X-ray Photography and Fluoroscopy Systems
Equipment Imaging Performance Acceptance Test
GB/T 19042.3 Evaluation and Routine Tests of the Medical Imaging Department Part 3-3.Digital Subtraction Angiography (DSA) X-ray
Line Equipment Imaging Performance Acceptance Test
YY/T 0202 Technical conditions for medical diagnostic X-ray tomography equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY 0505 Medical Electrical Equipment Part 1-2.Parallel Standard for General Requirements for Safety. Electromagnetic Compatibility Requirements and Tests
YY/T 0910.1 Medical Imaging Display System for Medical Electrical Equipment Part 1.Evaluation Method
YY/T 1708 (all parts) Basic requirements for connectivity compliance of medical diagnostic X-ray imaging equipment
3 Terms and Definitions
Terms and definitions defined in GB/T 10149, GB/T 19042.1, GB/T 19042.3 and YY/T 0910.1 apply to this document.
4 Classification and composition
4.1 Classification
Classification can be based on the intended use of the product and/or the structure of the product.
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