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YY/T 0746-2021: Particular specifications for medical X-ray equipment install on the vehicle
Status: Valid YY/T 0746: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0746-2021 | English | 119 |
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Particular specifications for medical X-ray equipment install on the vehicle
| Valid |
YY/T 0746-2021
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| YY/T 0746-2009 | English | 439 |
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particular specification for X-ray equipment installed on the vehicle
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YY/T 0746-2009
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PDF similar to YY/T 0746-2021
Basic data | Standard ID | YY/T 0746-2021 (YY/T0746-2021) | | Description (Translated English) | Particular specifications for medical X-ray equipment install on the vehicle | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 6,612 | | Issuing agency(ies) | State Drug Administration | YY/T 0746-2021: Particular specifications for medical X-ray equipment install on the vehicle---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Particular specifications for medical X-ray equipment install on the vehicle
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 0746-2009
Special technical requirements for vehicle-mounted medical X-ray diagnostic equipment
Released on 2021-03-09
2022-04-01 implementation
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0746-2009 "Special technical conditions for vehicle-mounted X-ray machines". This standard is compared with YY/T 0746-2009
The main changes are as follows.
---Modified the "normative references" (see Chapter 2, Chapter 2 of the.2009 edition);
---Modified "Terms and Definitions" (see Chapter 3, Chapter 3 of the.2009 edition);
--- Modified "Classification and Composition" (see Chapter 4, Chapter 4 of the.2009 edition);
--- Modified "Regulated by the product standard" to "Regulated by the manufacturer" (see Chapter 5 and Chapter 6, Chapter 5 and Chapter 6 of the.2009 edition
chapter);
---Modified "electric power", "loading factors and control", "imaging performance", "software function", "mechanical device performance", and "high-voltage cable plugs and plugs".
"Seat", "Appearance" and "Safety" requirements (see 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.12, 5.14 of the.2009 edition);
--- "Vehicle" is changed to "Space requirements of the vehicle" (see 5.3, 5.8 in the.2009 edition);
---Modified the "input power supply" (see 5.4, 5.9 of the.2009 edition);
---Modified "installation stability" (see 5.5, 5.10 of the.2009 edition);
---Modified the "environmental test" (see 5.7, 5.13 of the.2009 edition);
--- Modified 6.1.2a) [see 6.1.2a), 6.1.2a) of the.2009 edition];
---Modified "electric power", "loading factors and control", "imaging performance", "software function", "mechanical device performance", and "high-voltage cable plugs and plugs".
The test methods for "seat", "appearance" and "safety" (see 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.12, 6.14 of the.2009 edition);
--- Modify the title of "carriage vehicle" (see 6.3, 6.8 of the.2009 edition);
---Modified the "input power supply" (see 6.4, 6.9 in the.2009 edition);
---Modified the "environmental test" (see 6.7, 6.13 of the.2009 edition).
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee Medical X-ray Equipment and Apparatus Sub-Technical Committee (SAC/TC10
SC1) Centralized.
Drafting organizations of this standard. Liaoning Provincial Medical Device Inspection and Testing Institute, Shenzhen Akerui Electric Co., Ltd., Shenzhen Anke High Technology Co., Ltd.
Limited company.
The main drafters of this standard. Shan Xu, Wang Jianjun, Shi Jisheng, Wang Xiaotong, Ma Yue, Xie Tao, Liu Peng.
The previous versions of the standard replaced by this standard are as follows.
---YY/T 0746-2009.
Special technical requirements for vehicle-mounted medical X-ray diagnostic equipment
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and test methods of vehicle-mounted medical X-ray diagnostic equipment.
This standard applies to medical X-ray diagnostic equipment that is installed on a transport vehicle and the transport vehicle is in a stationary state for diagnosis.
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 9706.18 Medical electrical equipment Part 2.Special requirements for the safety of X-ray computed tomography equipment
GB/T 10149 Terms and Symbols for Medical X-ray Equipment
GB/T 19042.1-2003 Evaluation and routine tests in medical imaging departments Part 3-1.For X-ray photography and fluoroscopy systems
X-ray equipment imaging performance acceptance test
GB/T 19042.5-2006 Evaluation and routine tests in medical imaging departments Part 3-5.X-ray computed tomography equipment
Preparation imaging performance acceptance test
YY/T 0291-2016 Environmental requirements and test methods for medical X-ray equipment
YY/T 0310-2015 General technical conditions for X-ray computed tomography equipment
YY/T 0706-2017 Special technical conditions for breast X-ray machine
YY/T 0741-2018 Special technical conditions for digital photography X-ray machines
YY/T 0742-2021 Special technical conditions for gastrointestinal X-ray machine
YY/T 0745-2009 Special technical requirements for remote X-ray machine
3 Terms and definitions
GB 9706.18, GB/T 10149, GB/T 19042.1-2003 and GB/T 19042.5-2006 defined as well as the following terms and
The definition applies to this document.
3.1
On-board medical X-ray diagnostic equipment medicalX-ray equipmentinstalonthevehicle
Medical X-ray diagnostic equipment installed on a mobile transport vehicle, used to carry out X-rays on sites far away from the hospital under mobile conditions
Line diagnostic check.
4 Classification and composition
4.1 Classification
According to the product's intended use and/or product structure, it can be divided into.
a) X-ray computed tomography equipment;
b) Mammography camera;
c) Digital photography X-ray machine;
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