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YY/T 1106-2023: (electric operating table)
Status: Valid YY/T 1106: Evolution and historical versions
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| YY/T 1106-2023 | English | 319 |
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(electric operating table)
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YY/T 1106-2023
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| YY/T 1106-2008 | English | 150 |
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Electrically powered operating table
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Basic data | Standard ID | YY/T 1106-2023 (YY/T1106-2023) | | Description (Translated English) | (electric operating table) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.140 | | Word Count Estimation | 15,132 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2026-01-15 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements and test methods for electric operating tables. This standard applies to electric operating tables. | YY/T 1106-2023: (electric operating table)---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.
ICS 11.140
CCSC46
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 1106-2008
electric operating table
Released on 2023-01-13
2026-01-15 Implementation
Released by the State Drug Administration
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 4
Appendix A (Informative) Explanation of Basic Dimensions 10
Figure 1 Schematic diagram of basic dimensions 2
Figure 2 Leakage test [5.5a)] 4
Figure 3 Leakage test [5.5b)] 5
Figure 4 Leakage test [5.5c)] 5
Figure 5 Longitudinal swing (back tilt) 6
Figure 6 Longitudinal swing (forward tilt) 7
Figure 7 Lateral swing 8
Figure 8 Horizontal lateral swing 9
Table 1 Basic parameters 2
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document replaces YY/T 1106-2008 "Electric Operating Table". Compared with YY/T 1106-2008, except for editorial modifications, the main
The technical changes are as follows.
--- Increased term definition (see Chapter 3);
--- Added the size requirements for the side rails of the electric operating table (see 4.2);
--- Added the requirements for the post-environmental test inspection clause (see 5.10);
--- Modified the basic parameter requirements for a single action of the electric operating table (see 4.3, 3.3 of the.2008 edition);
--- Modified the requirements after installing accessories (see 4.7, 4.5 of the.2008 edition);
--- Modified the loading requirements in the leak test (see 5.5, 5.2 of the.2008 edition);
---Modified the schematic diagram for detecting the swing of the table (see 5.7, 5.4 of the.2008 edition);
--- Deleted Chapter 6 (Inspection Rules) and Chapter 7 (Marking, Instructions for Use, Packaging, Transportation, Storage) of YY/T 1106-2008
deposit) (see Chapter 6 and Chapter 7 of the.2008 edition).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5)
Focus on.
This document was drafted by. Shanghai Institute of Medical Device Testing, Microway Medical Equipment (Suzhou) Co., Ltd., Nanjing Mindray Biomedical Co., Ltd.
Therapy Electronics Co., Ltd.
The main drafters of this document. Xu Chao, Cen Jian, Tao Hua, Gu Xiaowei, Yu Qingfang, Zhang Jinmiao.
The previous versions of the documents replaced by this document are as follows.
---ZBC46006-1989;
---YY 91106-1999;
---YY/T 1106-2008.
electric operating table
1 Scope
This document specifies the performance requirements and test methods for electric operating tables. This document applies to electric operating tables.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY 9706.246 Medical Electrical Equipment Part 2-46.Particular Requirements for Basic Safety and Essential Performance of Operating Tables
3 Terms and Definitions
The following terms and definitions defined in GB 9706.1 and YY 9706.246 apply to this document.
3.1
Used in general surgery, orthopedics, neurosurgery, cardiothoracic surgery, gynecology, obstetrics, ophthalmology, urology, etc., the main intended use
It is the ME equipment or ME system that supports and operates the patient in multiple positions, making it placed in different postures.
Note. The electric operating table includes. table top, lifting column, base, transmission system and control system. In general, the countertop includes a backboard and a hipboard. may also include the header
board, waist board, arm rest board, leg board, foot board.
Electric operating table can be divided into. hydraulic type, pneumatic type, mechanical type.
3.2
Electric operating table intended for more than one specialized surgery.
Note. For example, electric operating tables that can be used for orthopedic surgery and neurosurgery.
4 requirements
4.1 Appearance
The appearance of the electric operating table should be flat, uniform in color, without defects such as scars and scratches.
4.2 Basic dimensions
The basic dimensions of the electric operating table shall comply with the regulations in Figure 1.
Table lifting stroke S should be greater than or equal to.200mm.
The size of the side rail of the electric operating table should meet a=10mm, b=25mm or a=8mm, b=30mm, and the tolerance should meet
±0.3mm. See Appendix A.
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