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GB 9706.7-2008 Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

Standard Number:  GB 9706.7-2008
Title:  Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
Language:  Simplified Chinese
Publication Date:  2008/3/24
Execute Date:  2009/1/1
Status:  Current
Standard Type:  Safety
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment>>Therapy equipment
Publisher:  Chinese Standards(GB)
Price:20.40  
Number of Pages:20  

Preface: All the technical content of this standard is mandatory. The standard equivalent adopts IEC60601  2  "00 (English version). This standard instead of GB9706.7-1994 "medical electrical equipment ultrasonic treatment equipment special safety requirements". This standard major change compared with GB9706.7-1994 As follows: - the standard name and IEC60601  2  "00 exactly; - refinement in scope and purpose of 1 to 1.1 1.2 purpose, scope, increased by 1.3, 1.4 for standard, 1.5 normative reference file; - in 2 Language added terms and definitions; - in 6.1 equipment or equipment parts for generator, external markers in the therapy of head increases the marking requirements; - in 6.8.2 increased use of declarations, instruction for use in the therapy of head of information requirements; - in 35 sound energy, test method in figure 10 1, change the hydrophone to through the coupling agent and treatment head wall coupling; - in 36 electromagnetic compatibility, increased against immunity test 3 v/m numerical rules; - change the figure of 102 to 101 in 42.3, and delete the original 42.4 supplement, generator's temperature rise test to 42.3 9), Increased unless it is confirmed to test a specific treatment head can obtain the result of the most unfavorable conditions, or cope with the manufacturers to provide every treatment head test; - set equipment in 44.6 ___________ into liquid treatment head should accord with the requirement of IPX7; - in 50 Work data, the accuracy of any power indicator and the actual value of deviation should be within the scope of the actual value plus or minus 30% to plus or minus 20% range; - in 50.101 the output control device, the power output dropped to under 20% to 5% of the rated output power; - in 51.103 the timer That will require revision accuracy as stipulated in the time range respectively; - in 51.104 radiation field uniformity, change the sound intensity than no more than 2 to manufacturers of any treatment or additional head beam non-uniformity coefficient should be no more than 8.0; - increase the informative appendices AA, is given to the requirement of appropriate is more important The principle of the instructions. A principle that chapter of the article and on the terms and conditions before have an asterisk  tag. Chapter 2 of this standard GB9706.1 and defined in terms of the standard in the text appear in boldface. The appendix of this international standard AA is informative appendices. This standard put forward by the state food and drug administration. By this standard The national medical ultrasonic equipment standards tumble technical committee to review. This standard drafting unit: wuhan medical ultrasonic instruments and quality supervision and inspection center. Ashmore, Wang Zhijian main drafter of this standard: busy. This standard replaced all previous releases of standard is: GB6386-1986; - GB9 706.7-1994  
Description:All the technical content of this standard is mandatory. This standard instead of gb9706.7-1994 "medical electrical equipment ultrasonic treatment equipment special safety requirements". This special standard specifies the safety requirements and test methods of ultrasonic therapy equipment, is to gb9706.1-2007 (based on iec60601 - "88 + + am2 am1) supplement and revision of the content. Suitable for medical ultrasound therapy equipment. This special standard does not apply Used for:
- driven by ultrasonic is used as the tool equipment (used in surgical and dental equipment, for example);
- use of focused ultrasound pulse wave shattered condensate, such as kidney or bladder stones equipment (crusher) (see gb9706.22-2003);
- use of focused ultrasonic ultrasonic therapy equipment. Compared with gb9706.7-1994 main changes of this standard are as follows:
- standard name exactly the same as that of iec60601-2 - "00;
- in the scope and purpose "1" to 1.1 "scope", the purpose of "1.2", increase the "1.3 special marks Tied for standard ", "1.4", "1.5" normative reference file.
- in the "2 terms and definitions" added terms;
- in "6.1 equipment or equipment parts of external markers" in the generator, the treatment head increases the marking requirements,
- in the "6.8.2 use manual" increased use of statement, information for the treatment of head and other requirements;
-- - In the "35 sound energy", the method eliminates the figure 101, change the hydrophone to through the coupling agent and treatment head wall coupling;
- in the electromagnetic compatibility "" 36, increased against immunity test 3 v/m numerical rules;
- in the "42.3" change the figure of 102 to 101, delete the original "42.4", the generator temperature rise test is changed to 42.3 9), increase the "unless Can confirm to test a specific treatment head can obtain the most unfavorable conditions as a result, or cope with the manufacturers to provide every treatment head test ",
- stipulated in the "44.6 into liquid" equipment in the treatment of head shall comply with the requirements of ipx7,
- in the "50 jobs data accuracy", will be "any power indicator and the actual value of deviation should be within the scope of the actual value plus or minus 30%" is modified to plus or minus Within the scope of 20%;
- in the "50.101 output control device", reduced output power to the rated power output of less than 20% to below 5%;
- in the "51.103" timer, amend accuracy requirements as stipulated in the time range respectively;
- in 51.104 the uniformity of the radiation field, change the "sound intensity ratio should not exceed 2" to "manufacturers provide any cure Cure head or additional beam non-uniformity coefficient should be no more than 8.0 ";
- increases the informative appendices aa, principle is given to the requirement of appropriate is more important.  
Cross References:
IEC 60601-2-5-2000,
GB 4208-1993;
GB 9706.1-2007;
GB 9706.22-2003;
GB/T 16540-1996;
IEC 60050(801)
  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  847KB
Tile in English:  Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

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