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YY/T 0746-2021Particular specifications for medical X-ray equipment installed on vehicles (English PDF)

车载医用X射线诊断设备专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2021

Implementation date

April 1, 2022

Scope

YY/T 0746-2021 is the English-translated version of 车载医用X射线诊断设备专用技术条件.

YY/T 0746-2021 is the Chinese pharmaceutical industry standard for vehicle-mounted medical X-ray diagnostic equipment, the mobile units in which an X-ray machine is installed in a vehicle and used while the vehicle stands still.

It gives the terms and definitions, the classification and composition of such equipment, the requirements and the test methods, covering the imaging performance, the mechanical fastening of the equipment against the movement of the vehicle, the power supply and earthing arrangements on board, the radiation protection of the compartment and its surroundings, and the environmental conditions the unit must withstand.

It replaces YY/T 0746-2009, was issued on 9 March 2021 and has applied since 1 April 2022.

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Document preview — YY/T 0746-2021

National Standard of the People's Republic of China

Classification
C 43
Replacing
YY/T 0746-2009

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Classification and composition

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).

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 document. 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

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;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY/T 0746

EditionTitleRevisionStatus
YY/T 0746-2021Particular specifications for medical X-ray equipment installed on vehiclescurrent editionCurrent
YY/T 0746-2009Particular specifications for medical X-ray equipment installed on vehiclesprevious editionSuperseded

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