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YY 0570-2013: Medical electrical equipment. Part 2: Particular requirements for the safety of operating tables
Status: Valid YY 0570: Evolution and historical versions
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| YY 0570-2013 | English | 349 |
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Medical electrical equipment. Part 2: Particular requirements for the safety of operating tables
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Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables
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Basic data | Standard ID | YY 0570-2013 (YY0570-2013) | | Description (Translated English) | Medical electrical equipment. Part 2: Particular requirements for the safety of operating tables | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 15,111 | | Older Standard (superseded by this standard) | YY 0570-2005 | | Adopted Standard | ICE 60601-2-46-1998; IDT | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: 2. 12. 101 Definitions Operating Table Safety requirements. Regardless of whether the electrical components of this operating table, including 2. 12. 104 Definitions gear. This transmission is used with removable tops the operatin | YY 0570-2013: Medical electrical equipment. Part 2: Particular requirements for the safety of operating tables
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Medical electrical equipment Part 2. Particular requirements for the safety of operating tables
ICS 11.040.99
C46
People's Republic of China pharmaceutical industry standards
YY 0570-2013/IEC 60601-2-46.1998
Replacing YY 0570-2005
Medical electrical equipment -
Part 2. Particular requirements for the safety of operating tables
Part 2. Particularrequirementsforthesafety
(IEC 60601-2-46.1998, IDT)
Issued on. 2014-10-01 2013-10-21 implementation
China Food and Drug Administration released
Table of Contents
Preface Ⅰ
The first chapter Overview 1
1. Scope and purpose 1
2 Terms and definitions 2
4 2 General test requirements
5 * Category 2
6 Identification, marking and documents 2
The second environmental conditions 3
Third of the risk of electric shock protection 3
17 isolation (original title. insulation and protective impedance) 3
18 protective earthing, functional earthing and potential equalization 3
19 Continuous leakage currents and patient auxiliary current 4
20 Dielectric strength 4
Title IV of the mechanical hazards Protection 4
21 Mechanical strength 4
22 moving parts 4
Stability of 524 normal use
The fifth chapter of unwanted or excessive radiation hazard protection 5
29 X-ray radiation 5
36 Electromagnetic Compatibility 5
Title VI of the danger of ignition of flammable anesthetic mixture Protection 6
Common claim 39 the AP and APG-type device type 6
Title VII of the ultra-mild additional safety hazard protection 6
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 6
49 power supply interruption 6
7 accuracy and prevent the risk of output data of the eighth chapter of the work
7 50 Operating data accuracy
Chapter 9. abnormal operation and fault conditions; environmental testing 7
Tenth Canto structural requirements 7
56 components and subassemblies 7
101 Potential equalization connection Figure 8
Test Chart safe working load of 102 9
Annex L (informative) Reference Standard --- publications mentioned in this standard 10
Annex AA (informative) Chapter 5, some types of applications based on the operating table of the total classification guidelines and preparation instructions 11
YY 0570-2013/IEC 60601-2-46.1998
Foreword
Medical electrical equipment standard series of standards, the series standard consists of two parts.
--- Part 1. General requirements for safety of medical electrical equipment;
--- Part 2. Medical electrical equipment requirements for the safety.
This special standard for medical electrical equipment - Part 2. The safety requirements for operating tables. This is a specific standard GB 9706.1-2007
"Medical Electrical Equipment Part 1. General requirements for safety" of changes and additions.
This dedicated drafting standards in accordance with GB/T 1.1-2009 given rules.
The specific standard replaces YY 0570-2005 "Medical electrical equipment - Part 2. Safety requirements for operating tables." The specific standard
Compared with YY 0570-2005 modified as follows.
--- Removed YY 0570-2005 with GB 9706.1-2007 duplicate content.
The use of specific standard translation method is equivalent to using the international standard IEC 60601-2-46.1998 "Medical electrical equipment - Part 2-46. Hand
Operating table for the safety requirements "(in English). The specific standard IEC 60601-2-46.1998 made the following editorial changes.
--- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail;
--- The standard auxiliary translation and GB 9706.1-2007 consistent.
The specific standard is based on GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (General Standard) spot
Standard, and supporting the use of GB 9706.1-2007.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
The specific standard by the National Medical Electronic Instruments Medical Electrical Standardization Technical Committee of Standardization Technical Committee (SAC/TC10/SC5) mention
And the focal point.
The specific standard drafting units. Shanghai Medical Device detection.
The main drafters of this specific standard. Xuyue Min, Qiu yuan.
The specific standard was first released in 2005.
YY 0570-2013/IEC 60601-2-46.1998
Medical electrical equipment -
Part 2. Particular requirements for the safety of operating tables
The first chapter outlines
Except for the following part of the General Standard Benpian chapter shall apply.
1 Scope and purpose
Except for the following part of this chapter apply to the General Standard.
1.1 Scope
Addition.
This standard specifies the special safety requirements 2.12.101 defined operating table. Regardless of whether this operating table electrical component, comprising
Gearing 2.12.104 definition. Taiwan surface such transmissions for operating table tops with removable bottom for the operating table (or
Base) drive.
The specific standard does not apply to.
--- Patient dental chair;
--- Check chairs and sofas;
--- Patient support system of diagnosis and treatment equipment;
--- Operating table heating blanket;
--- Patient transfer equipment;
--- Conveyor table and bed;
--- Beds;
--- Field operating table.
1.3 Specific Standard
Addition.
The specific reference standard GB 9706.1-2007. "Medical Electrical Equipment Part 1. General requirements for safety."
When the interest of brevity, in this specific standards referenced in Part 1, referred to as "General Standard" or "General requirements."
The specific standard of articles, number and the number of chapters and the General Standard of the corresponding. Change the text of the provisions of the General Standard using the following
vocabulary.
"Replace" means the General Standard of the chapter or article is dedicated entirely replace standard text.
"Supplement" means a standard text-based special supplement to the general requirements of the standard.
"Edit" means the General Standard chapter or article as modified by this specific standard text.
Added to the General Standard bar or FIG numbered starting from 101, the supplemental appendix organized into AA, BB, etc. Added entry for aa), bb) and the like.
The term "this standard" is used as the common standards and of the specific standard collectively.
If this specific standard no corresponding article, chapter or article, the General Standard article, chapter or article (although probably not related) will be no change to apply; if
GM intends to cite any part of the standard (although that may be relevant), will give a statement in this specific standard.
The specific requirements of the standard takes precedence over generic standards.
YY 0570-2013/IEC 60601-2-46.1998
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