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YY/T 0106-2008 English PDF (YY/T 0106-2021 Newer Version)

YY/T 0106-2008 (YY/T0106-2008, YYT 0106-2008, YYT0106-2008)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0106-2021English359 Add to Cart 4 days [Need to translate] (General technical conditions of medical diagnostic X-needle machine) Valid YY/T 0106-2021
YY/T 0106-2008English85 Add to Cart 0--9 seconds. Auto-delivery General specifications for medical diagnostic X-ray equipment Obsolete YY/T 0106-2008
YY/T 0106-2004EnglishRFQ ASK 9 days [Need to translate] General specifications for medical diagnostic X-ray equipment Obsolete YY/T 0106-2004
YY/T 0106-1993EnglishRFQ ASK 3 days [Need to translate] (Medical Diagnostic X-ray machine general technical conditions) Obsolete YY/T 0106-1993
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BASIC DATA
Standard ID YY/T 0106-2008 (YY/T0106-2008)
Description (Translated English) General specifications for medical diagnostic X-ray equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 9,930
Date of Issue 2008-10-17
Date of Implementation 2010-01-01
Older Standard (superseded by this standard) YY/T 0106-2004
Quoted Standard GB 5579; GB 9706.1-2007; GB 9706.3-2000; GB 9706.11-1997; GB 9706.12-1997; GB 9706.14-1997; GB 9706.15-1999; GB 9706.23-2005; GB 9706.24-2005; GB/T 10149; GB/T 19042.1-2003; GB/T 19042.3-2005; YY 0076-1992; YY/T 0202; YY/T 0291-2007; YY 0505-2005
Drafting Organization Beijing Wandong Medical Equipment Co., Ltd.
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) SFDA [2008] No. 605
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the diagnostic X-ray machine (hereinafter referred to as X-ray machines) Classification, requirements and test methods. This standard applies to diagnostic X-ray machine. For national or industry-specific requirements of the standard diagnostic X-ray machine, should perform the appropriate national or industry-specific standards. This standard does not apply to X-ray computed tomography device.


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.
YY/T 0106-2008 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.50 C 43 Replacing YY/T 0106-2004 General specifications for medical diagnostic X-ray equipment ISSUED ON. OCTOBER 17, 2008 IMPLEMENTED ON. JANUARY 1, 2010 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 6  4 Classification and composition ... 6  5 Requirements ... 6  6 Test methods ... 11  Foreword This Standard replaces YY/T 0106-2004 General specifications for medical diagnostic X-ray equipment. Compared with YY/T 0106-2004, the main changes are as follows. - Rewrote Clause 1 and defined the application scope of this Standard; - Added Clause 3 Terms and definitions; - Revised Clause 4 to define the product’s classification and composition requirements; - Reorganized Clause 5, so as to make the clauses and sub-clauses of this Standard clearer; revised or deleted some clauses and sub-clauses; - Deleted Appendix A (informative) Applicable national standards and industrial standards for X-ray equipment; - Deleted Appendix B (normative) Safety. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Sub-committee on Medical X- ray Equipment and Utensils of National Technical Committee on Medical Appliances of Standardization Administration of China. Drafting organizations of this Standard. Beijing Wandong Medical Equipment Co., Ltd., and Liaoning Provincial Medical Device Testing Institute. Main drafters of this Standard. Lu Jinming, Sun Lijuan, Liu Baishi and Chen Yong. This Standard replaces the following previous standards. - YY/T 0106-1993; - YY/T 0106-2004. General specifications for medical diagnostic X-ray equipment 1 Scope This Standard specifies the classification, requirements and test methods of medical diagnostic X-ray equipment (hereinafter referred as X-ray equipment, for short). This Standard is applicable to medical diagnostic X-ray equipment. For medical diagnostic X-ray equipment with national or industrial specific standard requirements, it shall perform the appropriate national or industrial specific standards. This Standard is not applicable to X-ray equipment for computed tomography. 2 Normative references The following standards contain the provisions which, through reference in this Standard, constitute the provisions of this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Standard. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, IDT) GB 9706.3-2000 Medical electrical equipment Part 2. Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (idt IEC 60601-2-7.1998) GB 9706.11-1997 Medical electrical equipment - Part 2. Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (idt IEC 60601-2-28.1993) GB 9706.12-1997 Medical electrical equipment - Part 1. General requirements for safety - 3. Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment (idt IEC 60601-1-3.1994) GB 9706.14-1997 Medical electrical equipment - Part 2. Particular requirements for the safety of associated equipment of X-ray equipment (idt IEC 60601-2-32.1994) GB 9706.15-1999 Medical electrical equipment - Part 1. General requirements for safety - 1. Collateral standard. Safety requirements for medical electrical systems (idt IEC 60601-1-1.1995) GB 9706.23-2005 Medical electrical equipment - Part 2-43. Particular requirements for the safety of X-ray equipment for interventional procedures (IEC 60601-2-43.2000, IDT) GB 9706.24-2005 Medical electrical equipment - Part 2-45. Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45.2001, IDT) GB/T 10149 Terminology and symbol for medical X-ray equipment GB/T 10151 Medical diagnostic X-ray equipment - Specifications for high voltage cable plugs and sockets GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments - Part 3-1. Acceptance test-Imaging performance of X-ray equipment for radiographic and radioscopic systems (IEC 61223-3-1.1999, IDT) GB/T 19042.3-2005 Evaluation and routine testing in medical imaging departments - Part 3-3.Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) (IEC 61223-3-3.1996, IDT) YY 0076-1992 Coating classifications for metal product - Technical conditions YY/T 0202 Specifications for medical diagnostic X-ray device for tomography YY/T 0291-2007 Environmental requirements and test methods for medical x-ray equipment YY 0505-2005 Medical electrical equipment Part 1-2. General requirements for safety Collateral standards. Electromagnetic compatibility Requirements and tests (IEC 60601-1-2.2001, IDT) value; b) Power frequency. 50 Hz ± 1 Hz; c) Power resistor stipulated by the product standard (stipulated adapted power resistor shall not be less than the values stipulated in Table 101 of 10.2.2a) of GB 9706.3-2000); d) Power capacity stipulated by the product standard. 5.2 Electric power 5.2.1 The maximum output power For X-ray equipment which works in continuous mode and/or intermittent mode, it shall stipulate the corresponding combination of X-ray tube voltage and X-ray tube current that causes the maximum output power. 5.2.2 Nominal electric power It shall stipulate that when loading time is 0.1 s, X-ray tube voltage is 100 kV, the maximum constant electrical power output provided by X-ray equipment in kW is the nominal electric power. If this value cannot be preselected, it can use the X-ray tube voltage value which is the closest to 100 kV AND the closest loading time value, however, it shall not be less than 0.1 s. The nominal electric power shall be provided with the combination of X-ray tube voltage, X-ray tube current and loading time. 5.3 Loading factors and control 5.3.1 X-ray tube voltage X-ray tube voltage shall comply with the following requirements. a) For X-ray equipment which works in continuous mode and/or intermittent mode, it shall stipulate X-ray tube voltage adjustment range and adjustment method; b) Product standard shall stipulate the deviation of X-ray tube voltage value, but it shall at least comply with. - For mammography X-ray equipment, requirements in 50.103.1 of GB 9706.24-2005; - For other X-ray equipment, requirements in 50.103.1 of GB 9706.3- 2000. If applicable, the ancillary equipment shall stipulate rotation angle range, longitudinal, lateral and vertical range of movement as well as its deviation. 5.5.2 Indicated value of Length The deviation value between indicated value of length and actual value shall be within ± 5% of the indicated value. 5.5.3 Indicated value of angle The deviation value between indicated value of angle and actual value shall be stipulated by the product standard. 5.5.4 Braking force Linear movement part in mechanical device shall have braking device (excluding the one in suspension device of which braking is nor required), and its braking force shall not be less than 100 N. 5.5.5 Start-up force Under continuous X-ray radiation conditions, for the movement part which requires manual operation, the start-up force shall not be greater than 50 N. 5.5.6 Load bearing The device that supports adult patients shall be able to work as normal after bearing 100 kg of weight. 5.5.7 Noise When X-ray equipment is operating in idling state (non-load bearing state), the noise it produces shall not be greater than 70 dB (A weighting network) (excluding unsustainable and aperiodic noise within 3 s). NOTE. It shall consider the composite noise produced by possible composite movement. 5.6 Software features If applicable, the product standard shall stipulate the features of operation software. 5.7 X-ray tomography apparatus It shall comply with the requirements of YY/T 0202. 5.8 High voltage cable plug and socket Sound level meter probe is 1 m away from X-ray equipment surface and 1.5 m away from the ground. Use sound level meter “A” weighting network to measure. Calculate based on the maximum noise value. 6.6 Software features Practical operation and observation. 6.7 X-ray tomography apparatus Conduct according to the provisions of YY/T 0202. 6.8 High voltage cable plug and socket Conduct according to the provisions in 5.8. 6.9 Appearance Visual observation. 6.10 Environment test Conduct according to the provisions of YY/T 0291-2007. 6.11 Safety Conduct according to the provisions of GB 9706.1-2007, GB 9706.3-2000, GB 9706.11-1997, GB 9706.12-1997, GB 9706.14-1997, GB 9706.15-1999, GB 9706.23-2005, GB 9706.24-2005 and YY 0505-2005. ......