GB 9706.4-2009 English PDF (GB9706.4-2009)

Delivery: 2 working-hours manually (Sales@ChineseStandard.net)
Need delivered in 3-second? USA-Site: GB 9706.4-2009
Get Quotation: Click GB 9706.4-2009 (Self-service in 1-minute)
Historical versions (Master-website): GB 9706.4-2009
Preview True-PDF (Reload/Scroll-down if blank)

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 of articles, chapters, corresponding article. Changes to the general body of the standard, the requirement to use the following words.
"Replace" indicates that common standards chapter or article to be completely replaced text of this standard.
"Supplement" means text of this standard is a general standard additions (or increase).
"Edit" means the General Standard or Chapter shall be the standard text-based content expressed.
Added to the General Standard bars and drawings are numbered starting from 101, appendix projects AA, BB and other labels, supplemental additions to aa),
bb) and other labels.
Theoretical description of chapters and bar labeled "" number. These theories instructions can be found in informative Annex AA. Appendix AA can be used to determine
The relationship between the proposed requirements for a given, but not used to establish additional test requirements.
If common standards and criteria in parallel some papers, chapters, this article is not listed in the corresponding standard, it means no change to apply. If you pass
GB 9706.4-2009/IEC 60601-2-2.2006
With a standard parallel or in any part of the standard, although that may be relevant, but does not intend to use, the impact of this standard on its clarification.
If a requirement of this standard is to replace or modify the General Standard or tied for the corresponding requirements of the standard, the requirements for priority to be universal
Seeking adoption.
2 Terms and definitions
Except as follows, common standards in this chapter apply.
Addition.
2.1.101
It expected to be used by the operator to produce the expected results of operations in the high frequency part of the patient attachment, usually by a surgical handle, surgical cable, hand
Connectors surgery and surgical electrodes.
2.1.102
Intended to be connected to a surgical operation output port attachment member, which may contain a finger snap switch connected to the switch detector to go
Some additional terminals.
2.1.103
The surgical handle extension member to the surgical site attachment.
2.1.104
Expected member by an operator handheld surgical accessories.
2.1.105
And high-frequency surgical equipment different, but the same electrical circuit connected to the patient and the device is not expected to be used alone.
2.1.106
Only two or more surgical electrode assembly on the same support, when energized, so that this structure is mainly in high-frequency current between the two electrodes
flow.
2.1.107
High-frequency surgical equipment or accessory devices, intended to be connected to the neutral electrode can be monitored, when in contact with patients to provide variation among electrode
Line alarm.
NOTE. Only use neutral electrode can be monitored, the contact quality monitoring device to work.
2.1.108
Application may be part of medical electrical equipment, but not endoscopic device, like an endoscope introduced into a patient through the same channels
An annex.
2.1.109
It is usually contained within a surgical attachment device, controlled by the operator to start the high-frequency output, when released can ban high-frequency output.
Note. do not expect to make a similar switch requires high-frequency output start still under consideration.
2.1.110
Intended for transmission, supplement or monitor attachment of high frequency energy from the high frequency surgical device applied to a patient.
GB 9706.4-2009/IEC 60601-2-2.2006
Note. Accessories include high-frequency high-frequency electrode, and connect them to high-frequency surgical equipment up cables and connectors, and intend to work with the high-frequency circuits surgery
Other ancillary equipment connected.
2.1.111
Expected neutral electrode contact quality monitors for use with.
Note. Only the same can be used together to monitor the neutral electrode contact quality monitors to work.
2.1.112
High-frequency surgical equipment or accessory devices, intended to be connected to a neutral electrode (neutral electrode can be monitored except) circuit, which electrodes
Provides alarm cable or connector Electrical outage.
Note. The neutral electrode is expected to only be used for continuous monitoring of non-neutral electrode monitoring.
2.1.113
For connecting with the patient's body, an electrode having a relatively large area, low current density is expected to provide a high-frequency current
Return channel, to prevent undesirable physical effects such burns in human tissues.
Note. also known as neutral electrode plates, the electrode plate, a negative electrode, a return electrode or a dispersive electrode.
2.1.114
Part of the high-frequency surgical equipment or ancillary equipment, which means the press in response to the connected switch or foot switch to control the operation of the high-frequency output
Start.
2.2.101
Including related accessories, including medical electrical equipment, it is expected to use a high-frequency current surgical procedures, such as biological tissue cut (cut) or condensate
(solid).
2.3.101
Fixed to the surgical electrode member electrically insulating material, it is expected to prevent the operator or the patient's tissue adjacent undesirable
damage.
2.4.101
For each high-frequency operation modes are available in each of the patient circuit connections (points) occurred between the maximum possible peak frequency output power
Pressure value.
2.4.102
Accessories and monopolar high frequency maximum output voltage between the neutral electrode connected to the patient may be applied. For bipolar high frequency surgical accessories,
It is applied to the maximum output voltage of opposite polarity between a pair of electrodes.
2.7.101
Accessory intended for surgery or high-frequency surgical equipment and ancillary equipment connected to deliver high-frequency current components.
2.12.101
The method of applying high-frequency current output through the multi-polar electrode surgery to the patient.
GB 9706.4-2009/IEC 60601-2-2.2006
2.12.102
A high-frequency current to raise the tissue temperature, e.g., reduction or suspension of unwanted bleeding.
Note. The condensate can be contacted (formula) condensate or non-contact (type) condensate.
2.12.103
The use of high-density high-frequency current surgical electrodes so that the body tissue removal or separately.
2.12.104
Patient circuit is equipped to provide high-frequency current low resistance path to ground elements, such as capacitors.
2.12.105
Use long EDM (≥0.5mm), surgery and without mechanical contact between the electrode and the tissue, so to ...