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GB 9706.4-2009: Medical electrical equipment -- Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
GB 9706.4-2009
Medical electrical equipment.Part 2-2. Particular requirements for the safety 0f high frequency surgical equipment
ICS 11.040.30
C41
National Standards of People's Republic of China
GB 9706.4-2009/IEC 60601-2-2.2006
Replacing GB 9706.4-1999
Medical electrical equipment -
Part 2-2. Particular requirements for the safety of high frequency surgical equipment
(IEC 60601-2-2.2006, IDT)
Posted 2009-05-06
2010-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
Introduction Ⅱ
The first chapter Overview 1
1. Scope and purpose 1
2 Terms and definitions 2
3 4 General requirements
4 5 General test requirements
5 Category 5
6 Identification, marking and documents 5
7 Input power 8
The second environmental conditions 8
Third of the risk of electric shock protection 8
Requirements concerning classification 14 8
17 8 Isolation
18 protective earthing, functional earthing and potential equalization 9
19 Continuous leakage currents and patient auxiliary current 9
Dielectric strength 20 13
Title IV of the mechanical hazards Protection 14
The fifth chapter of unwanted or excessive radiation hazard protection 14
36 14 Electromagnetic Compatibility
Title VI of the danger of ignition of flammable anesthetic mixture Protection 14
Common claim 39 the AP and APG-type device type 14
Title VII of the ultra-mild other security risk protection 14
42 Overtemperature 14
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, disinfection, sterilization and compatibility 15
46 15 human error
16 accuracy and prevent the risk of the output data of the eighth chapter of the work
1650 data accuracy work
1851 to prevent the risk of output
Chapter 9. abnormal operation and fault conditions; environmental testing 19
52 abnormal operation and fault status 19
Tenth Canto structural requirements 20
56 20 components and subassemblies
59 and the wiring structure 22
Annex L (normative) References --- this standard relates to publication 29
Annex AA (informative) special chapter of the guidelines and principles 30
Electromagnetic Annex BB (informative) high-frequency surgical equipment generates harassment 45
GB 9706.4-2009/IEC 60601-2-2.2006
Foreword
All technical content in this section is mandatory.
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 section Medical electrical equipment - Part 2 requirements for the safety of high frequency surgical equipment. This section should be national standards
GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" supporting the use of. The requirements of this section apply to priority
The standard Terms and Conditions.
This section identical with the international standard IEC 60601-2-2.2006 "Medical electrical equipment Part 2-2. High-frequency surgical equipment safety professionals
With the requirements. "
For ease of use, IEC 60601-2-2.2006 made the following editorial changes.
--- For other international standards quoted in the standard, if it has converted to our standards, international standards will replace the corresponding reference number of the country
Standard home;
--- Remove IEC 60601-2-2.2006 standard cover and foreword.
This Part replaces GB 9706.4-1999 "Medical electrical equipment Part 2. requirements for the safety of high frequency surgical equipment."
This section is compared with GB 9706.4-1999, the main differences include.
--- Definitions of terms and the contents of supplements;
--- In the instructions for use and a greater rated accessory voltage and neutral electrode monitoring description requirements;
--- Increased transverse high frequency circuit coupled between the requirements of different patients in the high-frequency leakage current;
--- Increased requirements for high frequency surgical equipment under a single fault condition incorrect output;
--- The content of 56.11 made rearrange and supplement;
--- Original standards replace Section 101 Chapter 59, and a larger increase in the length of the content and requirements.
This section Appendix L, Appendix AA, BB appendix is informative appendix.
This part is proposed by the State Food and Drug Administration.
This part of the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This section is drafted. Shanghai Medical Device detection, Shanghai and Shanghai Electronics Co., Ltd..
The main drafters of this section. Xuyue Min, Miss E, deposition kernels.
This part of the standard replaces the previous editions are.
--- GB 9706.4-1992, GB 9706.4-1999.
GB 9706.4-2009/IEC 60601-2-2.2006
introduction
IEC 60601-2-2 fourth edition of the original version made extensive revisions, a new version is released in order to improve readability and
Versatility. You can feel the changes in technology and safety improvements range version offers quite broad, and that the new common standards for the desired coordination
It is very important.
GB 9706.4-2009/IEC 60601-2-2.2006
Medical electrical equipment -
Part 2-2. Particular requirements for the safety of high frequency surgical equipment
The first chapter outlines
Except as follows General Standard Benpian apply.
1 Scope and purpose
Except as follows, common standards in this chapter apply.
1.1 Scope
Addition.
This standard specifies the special safety requirements for high-frequency surgical equipment and high frequency medical 2.1.110 defined in the annex to this equipment and accessories
Hereinafter referred to as high-frequency surgical equipment.
Rated output power not exceeding 50W high-frequency surgical equipment (such as micro-coagulation device, or for dental or ophthalmic devices) are excluded
In addition to some special requirements of this standard, these exclusions will be specified in the related request.
1.2 Purpose
replace.
The purpose of this standard is to provide specific requirements for the safety of high frequency surgical equipment.
1.3 Specific Standard
Addition.
The specific standard for the following set of standards and IEC publications made changes and additions.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. Safety requirements for medical electrical systems
Seek (IEC 60601-1-1.2000, IDT)
YY0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Collateral standard. Electromagnetic compatibility requirements and test
Test (IEC 60601-1-2.2001, IDT)
IEC 60601-1-4.1996 Amendment 1 (1999) Medical electrical equipment - Part 1. General requirements for safety 4. Collateral Standard. Programmable
Cheng medical electrical systems
For simplicity, in this specific standard GB 9706.1 may be referred to as "General Standard" or "General requirements", and GB 9706.15,
YY0505-2005 and IEC 60601-1-4 called "collateral standard."
The term "this standard" contains specific standards and the General Standard and any Collateral standard one used.
General This standard number...