HOME   Cart(1)   Quotation   About-Us Tax PDFs Standard-List
Powered by Google-Search & Google-Books www.ChineseStandard.net Database: 189760 (28 Jan 2023)

YY/T 0106-2021 (YYT 0106-2021)

YY/T 0106-2021_English: PDF (YYT0106-2021)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)Related StandardStatusPDF
YY/T 0106-2021English359 Add to Cart 4 days (General technical conditions of medical diagnostic X-needle machine) YY/T 0106-2021 Valid YY/T 0106-2021

BASIC DATA
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 m