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GB 9706.7-2008: Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete GB 9706.7: Historical versions
Similar standardsGB 9706.7-2008: Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB9706.7-2008 Medical electrical equipment.Part 2-5.Particular requirements for the safety of ultrasonic physiotherapy equipment ICS 11.40.60 C41 National Standards of People's Republic of China GB 9706.7-2008/IEC 60601-2-5.2000 Replacing GB 9706.7-1994 Medical electrical equipment - Part 2-5. Requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5.2000, IDT) Published 2008-03-24 2009-01-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued ForewordAll technical contents of this standard is mandatory. This is equivalent to using the standard IEC 60601-2-5.2000 (English). This standard replaces GB 9706.7-1994 "Medical electrical equipment requirements for the safety of ultrasonic therapy equipment." This major change compared to the standard GB 9706.7-1994 follows. --- Standard IEC 60601-2-5 and name.2000 exactly the same; --- In the "scope and object 1" in the refinement as a "scope 1.1", "1.2 Purpose", increasing the "specific standard 1.3", "1.4 and Standard columns "," Normative References 1.5 "; --- "2 Terms and Definitions" terminology has been added; --- In the "external device or marking 6.1 Part" for the generator, increasing the treatment head marking requirements; --- In the "6.8.2 User Guide" increased use caution statements, and other information required treatment head; --- In the "acoustic energy 35 'in FIG deleted Test Method 101, the hydrophone is coupled to the side wall via a coupling agent to the treatment head; --- in "Electromagnetic Compatibility 36", increasing the predetermined value of immunity tests 3V/m of; --- In "42.3" in FIG 102 to 101, deleting the original "added 42.4", the temperature of the test generator 9 to 42.3), Added "unless it can be proven to be a particular treatment head test results obtained under the most adverse conditions, otherwise respond manufacturing Provided by each treatment head test "requirement; --- In "44.6 into the liquid" in the treatment of head and provides equipment shall meet the requirements of IPX7; --- In the "accuracy of the 50 working data", the "indicate any deviation from the actual power value should be within ± 30% of the actual value" Modify the range of ± 20%; --- the "50.101 output control means" in the output power to 20% of the rated output power to 5% or less; --- In the "51.103 Timer", the accuracy requirements are revised by a predetermined time range; --- In the "homogeneous radiation field of 51.104", the "sound intensity ratio of not more than 2" to "any treatment head manufacturer or additional Beam head unevenness factor should not exceed 8.0 "; --- increasing the informative Appendix AA, for the appropriate requirements of the more important given the principle of explanation. There are chapters explain the principles of Article marked with an asterisk before their terms of numbers. The term standard GB 9706.1 chapter 2 and defined, they appear in bold represents the standard texts. Annex AA of this standard is an informative annex. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of medical ultrasound equipment. Drafted. medical ultrasound equipment Wuhan National Quality Supervision and Inspection Center. The main drafters. Ashmore busy, Wang Zhijian. This standard supersedes the previous editions are. --- GB 6386-1986; --- GB 9706.7-1994. GB 9706.7-2008/IEC 60601-2-5.2000introductionThis standard specifies the special safety requirements and test methods ultrasound therapy apparatus, is GB 9706.1-2007 (based on IEC 60601- Amendments and additions 1988 + Am1 + Am2, hereinafter referred to as Common Criteria) content. 1.This takes into account the specific standard and YY0505-2005 IEC 61689.1996 content. The first edition of this specific standard equivalent to using IEC 60601-2-5.1984 (based on IEC 60601-1.1977 and reference IEC 60150). The purpose is to make the second edition of this specific standard updated to keep pace with the above referenced publications and documents. Change the subject In order to better reflect the scope of application development based on ultrasound treatments, and consistent with the change above IEC standard. Taking into account the understanding of the requirements of the more important reasons not only help correct application of the specific standard, and with the change in clinical practice Development and technology change, timely revised standard is necessary, given in Annex AA principles appropriate description of these requirements. but This appendix is not a part of this standard. GB 9706.7-2008/IEC 60601-2-5.2000 Medical electrical equipment - Part 2-5. Requirements for the safety of ultrasonic physiotherapy equipment The first chapter outlines In addition to the following, chapter and section of the General Standard Benpian apply. Scope 1 and object 1.1 Scope increase. This standard specifies the safety dedicated 2.1.101 defined physiotherapy equipment using ultrasound transducer unit in medical practice Claim. This does not apply to specific standard. --- equipment consists of an ultrasonically driven tool is used (for example, surgical and dental equipment); --- pulverized using a focused ultrasound pulse GB aggregates such as kidney or bladder stones apparatus (lithotripter) (see 9706.22- 2003); --- focused ultrasound using an ultrasonic physiotherapy equipment. 1.2 Purpose Alternative. The purpose of this standard is to establish special requirements for the safety of use in medical practice as defined in 2.1.101 ultrasonic physiotherapy equipment. 1.3 Specific Standard increase. This specific standard reference GB 9706.1-2007/IEC 60601-1.1988 "Medical Electrical Equipment Part 1.General requirements for safety" For brevity, in this specific standard referred to in the first part "General Standard." This medium-length specific standard, chapter and section numbers correspond to common standards, changes to standards common in the content, require the use of the following wording. "Replacement" means General Chapter criterion is completely replaced by the content-specific criteria. Content "increase" means increased specific standard requirements in the General Standard. "Fix" means General Chapter amended standard is expressed as content-specific standards. General Standard strip or FIG increased, starting from the number 101, increased Appendix letters AA, BB, etc., by increasing the amount to AA), bb) and the like represent. The term "present standard" is used and refers to the overall general standard of this specific standard. Although may not be relevant, without corresponding articles in the specific standard, the number of chapters bars, universal standard articles, Chapter article without modification Mining Use; although may be related, but not ready to use any common part of the standard, given in the statements relating specific standard. Standard requires special preference to the following common standards and criteria in parallel. 1.4 Collateral Standard increase. Side by side with the following standard GB 9706.15-1999 Medical Electrical Equipment Part 1.General requirements for safety. Collateral standard. medical electrical systems security General Requirements (idt IEC 60601-1-1.1995) YY0505-2005 Medical Electrical Equipment Part 1-2.General requirements for safety Collateral Standard. EMC requirements and tests GB 9706.7-2008/IEC 60601-2-5.2000 (IEC 60601-1-2.1993, idt) IEC 60601-1-4.2000 Medical Electrical Equipment Part 1-4.General requirements for safety Collateral Standard. Programmable Electrical Medical system 1.5 Normative References Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard Whether the latest versions of these documents. For undated references, the latest version applies to this standard. GB 4208-1993 shell protection (IP code) (eqv IEC 60529.1989) GB 9706.1-2007 Medical Electrical Equipment Part 1.General requirements for safety (IEC 60601-1.1988, IDT) GB 9706.22-2003 Medical electrical equipment - Part 2.In vitro safety of equipment for initiator (IEC 60601-2- 36.1997, MOD) Ultrasound field characteristics GB/T 16540-1996 acoustic frequency in the range of 0.5 ~ 15MHz and hydrophone measurement method (Eqv IEC 61102.1991) IEC 60050 (801) International Electrotechnical Vocabulary - Chapter 801.Acoustics and electro-acoustics IEC 60469-1.1987 and Pulse Technique - Part 1.Pulse terms and definitions IEC 61161.2006 and ultrasound radiation force balance performance sound power measurement requirements IEC 61689.1996 within a frequency range of 0.5MHz ~ 15MHz physical therapy ultrasound system performance requirements and test methods2 Terms and DefinitionsIn addition to the following, common standards in this chapter applies. 2.1 parts and accessories and attachments Increase definitions. 2.1.101 For therapeutic purposes, and generate ultrasonic device acts on the patient. NOTE. The device consists essentially of a high-frequency power generator and to convert it to an ultrasonic transducer components. 2.1.102 In the ultrasonic frequency range converts electrical energy into mechanical energy device. 2.1.103 By the ultrasound transducer and the ultrasound assembly locally in the patient-related members thereof. Note. The treatment head is also referred to the role of head. 2.1.104 An ultrasonic beam to change the properties of the treatment tip attached accessory. 2.12 Other 2.12.101 At rated grid voltage, maximum output power of the device. [IEC 61689.1996 definition of 3.32] GB 9706.7-2008/IEC 60601-2-5.2000 2.12.102 Audible sound frequency higher than the upper limit frequency (above 16kHz) oscillation. (See IEC 60050 (801) of 801-21-04) [IEC 61689.1996 definition of 3.45] 2.12.103 Extrapolation to the beam cross-sectional area of the front end face of the treatment head, is multiplied by a dimensionless coefficient defined by IEC 61689. [IEC 61689.1996 definition of 3.20, Change] NOTE. It is considered that the treatment tip end surface comprise 100% of the total area of the mean square of sound power. 2.12.104 Ratio of the output power and the effective radiation area, in watts per square centimeter units. [IEC 61689.1996 definition of 3.18, Change] 2.12.105 The hydrophone output in the sound field, using acoustic signals through frequency analysis of the zero-crossing technique observed. (see GB/T 16540-1996 3.4.1) [IEC 61689.1996 is defined 3.3] 2.12.106 The average ratio of the maximum effective value of the square of the rms sound pressure of the sound pressure square space, where the determined effective in accordance with IEC 61689 The average radiation within a spatial area. [IEC 61689.1996 definition of 3.9, Change] 2.12.107 There are three illustrative ultrasonic beam classification. type collimator, convergent, divergent. [IEC 61689.1996 definition of 3.11] 2.12.108 Than the period of the pulse duration and pulse repetition. (See IEC 60469-1 is 5.3.2.4) [IEC 61689.1996 definition of 3.17] 2.12.109 Treatment head device under certain conditions, free-field approximation to a particular medium (preferably water) in the time-averaged irradiation ultrasonic power. (See IEC 61161.2006 3.5) [IEC 61689.1996 definition of 3.31] 2.12.110 When the amplitude of the sound pressure exceeds the reference value and the first time the magnitude of sound pressure and finally back to the reference value, the time interval between the two. Reference value, etc. The most sound pressure amplitude and difference between maximum and minimum sound pressure amplitude of 10% of the sum of the two. [IEC 61689.1996 definition of 3.35] NOTE. modulation is considered incomplete, IEC 61689.1996 is as defined above and GB/T 3.30 the difference 16540-1996. GB 9706.7-2008/IEC 60601-2-5.2000 2.12.111 When the same waveform periodically repeating features, both the absolute value of the time interval. (See IEC 60469-1.1987 in 5.3.2.1) [IEC 61689.1996 definition of 3.36] 2.12.112 In the case of amplitude modulation wave, equal to the ratio of the output time of the maximum effective radiated power and area. [IEC 61689.1996 definition of 3.41, Change] 2.12.113 In the case of amplitude modulation wave, the actual output power, time and RMS sound pressure peak sound pressure function regulation according to IEC 61689 Scheduled OK. [IEC 61689.1996 definition of 3.34, Change] General requirements 4 test In addition to the following, common standards of this chapter applies. 4.1 test Additional comments in Appendix AA. Category 5 In addition to the following, common standards of this chapter applies. 5.6 Fixed. In addition to "continuous operation", the delete all other terms. 6 identify, mark and file In addition to the following, common standards of this chapter applies. External marking device or apparatus components 6.1 p) output Alternative. 1.Additional generator apparatus should additionally the following tags. --- in MHz operating frequency sound (at 1MHz lower than in kHz) --- waveform (continuous wave or pulse amplitude modulation wave) --- If amplitude modulation wave amplitude for each of a set providing a description or illustrated in the output waveform, and the pulse duration, pulse repetition Multiplexing period and duty cycle values. 2.Generator should be accompanied by a permanent plate, and given a unique serial number of identification in order to separate. 3.Treatment head should be labeled in W rated output power, the effective radiation area in cm2 of the unit, a beam-based nonuniformity Number, the beam type, specifying the treatment head supporting device specific high-frequency power generator [if applicable, see 6.8.2aa) 9)] and that it is unique based Column number. 6.8.2 Manual Increased provisions. aa) should include the following instructions. 1) Effective any additional treatment tip or head or in kHz acoustic operating frequency in MHz unit, and in square centimeters GB 9706.7-2008/IEC 60601-2-5.2000 Radiation area. 2) to prompt the user for periodic maintenance recommendation observations need to focus on, in particular. --- user performance test interval and calibration; --- inspection of the conductive liquid penetration may result in cracking of the treatment head; --- examination and additional treatment head cable connector. 3) Recommendations for safe operation of the necessary steps, the application part is a B type, the emphasis may lead to improper electrical installation Safety hazard. 4) the type of electrical installation equipment can secure connection, including any recommendations equipotential conductor connection. 5) cause the user's attention, be careful about the use of the treatment head, rough handling to avoid irreversible consequences may be caused by the performance characteristics of Suggest. 6) treatment of head and exception handling list of cases. 7) Use caution statement. 8) Optional treatment head information. 9) of the generator for a predetermined impossible, and includes the ability to exchange treatment head, should be marked, and the method should be interchangeable described.7 Input PowerEquipment operating conditions common standard provisions of this chapter, see Chapter 50. The second environmental conditions In this part apply common standards. Title III protection against electric shock hazard In addition to the following, the contents of common standards Benpian apply. 13 Overview increase. For the case of a combination of devices (i.e., an electrical stimulation device additionally provides means functions or applications), the device should also meet additional functionality specific standard Quasi-specified safety requirements. Title IV of protection against mechanical hazards In addition to the following, the contents of common standards Benpian apply. 21 Mechanical strength 21.5 Conformance testing Increase paragraph. After the test, the first treatment should meet the requirements of this specific standard 51.104. The fifth chapter of unwanted or excessive radiation hazard protection In addition to the following, the contents of common standards Benpian apply. 35 acoustic energy (including ultrasound) Alternative. When the following conditions for measurement, the spatial peak temporal average acoustic handheld ultrasound treatment head does not need to be less than the radiation intensity GB 9706.7-2008/IEC 60601-2-5.2000 100mW/cm2. By the following tests to verify conformance to requirements. The front end surface of the treatment head is immersed in the water temperature was 22 ℃ ± 3 ℃ of degassed water, the device work in the treatment of a predetermined first rated output power, has Calibrated hydrophone is coupled via a coupling agent to the treatment tip sidewall, scanning (hand), the first side wall measuring treatment of unwanted ultrasonic radiation. Note. The requirements related to the output power and sound intensity distribution, see Part VIII. 36 Electromagnetic Compatibility Alternative. In addition to the following, the equipment shall comply with the requirements of the relevant standards YY0505. Increase the sentence. Test for immunity, a predetermined value of 3V/m of. Alternative. During the test, using the following operating conditions. --- treatment head is immersed in water, set at half the maximum output power and maximum values. --- if the output circuit by controlling the terminal is tuned at the resonance should be measured and detuning. Title VI of the risk protection ignite flammable anesthetic gases mixed The contents of general standard Benpian apply. Title VII of the ultra-mild other security risk protection In addition to the following, the contents of common standards Benpian apply. 42 overtemperature 42.3 Conformance testing Increased provisions. 6) the treatment head normal handheld use, immersed starting temperature was 25 ℃ ± 1 ℃, the total depth of not less than 20cm, 2L of water to the water tank At 1cm below the surface. 3min device operates at the rated output power of the treatment head, and then out of the water treatment head 15s Immediately after immersion in water, the above-described process is repeated three times (total test time 9min45s) (see FIG. 101). 7) only in water, but not intended for the treatment of head handheld device, a quantity of water to be completely immersed in 2L of water, the cure Working 15min tested at rated output power of the treatment head. NOTE. To ensure a uniform temperature distribution, may require some form of mechanical agitation. (See Appendix AA, about 42.3) 8) at any time during 6) or 7) test, the surface temperature of the radiation should not exceed 41 ℃. Note 1.In order to avoid direct heating of the temperature measuring device, the temperature during the measurement, the instantaneous power failure may be required for the therapy head. Note 2.To avoid the additional thermal effects resulting from reflected ultrasonic tank side wall and a bottom, side walls and bottom of the tank should be in the sound absorbing lining material. 9) the treatment head is immersed in a container filled with water, which is the starting temperature of 25 ℃ ± 1 ℃, the rated output power, in compliance with its duration Terms of follow common standards compliance test 42.3 3) under the condition of "sustained rate", Rise Test generator. Unless Proven to be a particular treatment head test results obtained under the most adverse conditions, or respond to every manufacturer A treatment head test. GB 9706.7-2008/IEC 60601-2-5.2000 FIG temperature rise test radiating arrangement 101 in FIG. (See 42.3) Overflow 44, liquid spill, leak, moisture, into the liquid, cleaning, disinfection, sterilization and compatibility 44.6 inlet increase. 101) treatment of head and equipment should meet the IPX7 GB 4208's. GB 4208 according to the treatment head comprises a test socket connection cables to verify conformance to requirements. 102) of both pressure massage function ultrasonic therapy, the treatment should withstand the maximum pressure generated. 44.6101 tested as described above) to verify conformance to requirements, the maximum compressive load that is generated under conditions of normal use 1.3 times the force. The accuracy and prevent the risk of data output from the eighth chapter of the work In addition to the following, the contents of common standards Benpian apply. The accuracy of the data 50 work 50.1 marking instruments and control means Alternative. 50.1.101 should control the output device in the form of a meter or calibration, provide a quantitative indication means on the control panel. The indicating means You should be able to directly read or display. a) in a continuous wave mode of operation, the output power and effective sound intensity, and b) In the amplitude modulation mode, time and time of maximum intensity of the maximum output power. Above measurements should be carried out immediately after the preheating time specified random file, shall IEC 61689.measurement Chapter 8 1996 To verify conformance to requirements. 50.1.102 when any indication of the apparatus in 50.1.101 having two or more measurement range, should provide a clear and reliable The range indication. GB 9706.7-2008/IEC 60601-2-5.2000 By checking to verify conformance to requirements. Any deviation of the actual value of the power instruction in said 50.1.103 50.1.101, it will be in the range of ± 20% of the actual value. By measuring and checking to verify compliance with the requirements. the time of the maximum output power measurement mode of amplitude modulation, continuous wave operation mode Formula measured output power. Shows the measured values, should be greater than the maximum value shown (range) of 10%. NOTE. output power and effective sound intensity quotient is effective radiating area, above 20% limit is automatically adapted to the two types of instructions. Prevent dangerous 51 output In addition to the following, the contents of this chapter apply common standards. 51.5 incorrect output Alternative. Any maximum effective acoustic treatment tip or head of the additional strength provided by the manufacturer should not exceed 3W/cm2, this requirement applies to the normal state and Any single fault condition. By measuring and measuring 50.1 effective rated output power of the radiation area to verify conformance to requirements. increase. Output control means 51.101 Device shall be equipped with a one way (An output control device), to ensure the output power to 5% or less of the rated output power. By measuring the output power rating of 50.1, to verify conformance to requirements. Output power stability when the fluctuation 51.102 Voltage fluctuation of ± 10%, variations in output power should be within ± 20%. Again not allowed by manually adjusting device To meet this requirement. At 90%, 100%, 110% grid voltage conditions, by measuring the rated output power of 50.1 to verify conformance to requirements. 51.103 timer Device shall be equipped with an adjustable timer OFF output after reaching a predetermined time. Timer range should not exceed 30min, to be accurate Requirements are as follows. Timer setting accuracy Less than 5min ± 30s ± 10% 5min 10min to a set value Greater than 10min ± 1min Homogeneity of the radiation field 51.104 Any additional treatment head or head beam unevenness factor provided by the manufacturer should not exceed 8.0. Measuring compliance with the requirements of Chapter 8 1996, to verify. by according to IEC 61689. Stability of the output time 51.105 Period at maximum rated output power and grid voltage, 23 ℃ ± 3 ℃ temperature condition, continuous operation for 1h, constant output power should Its initial value within a range of ± 20%. 51.106 operating frequency sound Sound operating frequency should comply with 61689 IEC.1996 requirements. Chapter 9.abnormal operating and fault states; Environmental Testing The contents of general standard Benpian apply. Tenth Canto structural requirements In addition to the following, the contents of common standards Benpian apply. GB 9706.7-2008/IEC 60601-2-5.2000 Component assembly 56 and 56.3 connection - Overview Increased provisions. aa) in the connecting cable connected to the treatment head at a joint head and treatment equipment, should have the ability to protect excessive bending, or respectively Proper connection plug. Both ends of the connecting cable, power cable test method General Standard 57.4b) under test, to verify whether the Claim. GB 9706.7-2008/IEC 60601-2-5.2000 In addition to the following, common standards and appendix apply. Appendix L Increase the reference standard GB 9706.22-2003 Medical electrical equipment - Part 2.In vitro safety of equipment for initiator (IEC 60601-2-36. 1997, MOD) Ultrasound field characteristics GB/T 16540-1996 Acoustics in the frequency range 0.5-15 MHz and hydrophone measurement method (Eqv IEC 61102.1991) IEC 60050 (801).1994 International Electrotechnical Vocabulary Chapter 801.acoustic and electro-acoustic IEC 60469-1.1987 Part pulse technology and 1.Pulse terms and definitions IEC 61161.1992 0.5MHz to 25MHz frequency range of the ultrasonic power measurement correction members in the liquid 1 (1998) 1) Performance requirements and methods of measurement within the treatment system 1996 0.5MHz to 5MHz ultrasonic frequency range. IEC 61689 1) version 1.1 has been revised after, including IEC 61161.1992 and its amendments pieces of 1.1998. GB 9706.7-2008/IEC 60601-2-5.2000 Appendix AA (Informative) The total preparation instructions and guidelines This appendix important standard required to give a Jian Ming description of the preparation, the purpose of this standard for the familiar theme, but did not participate in its system Given staff to help. Taking into account the proper application of the understanding of the main requirements of the standard is essential, and with the clinical practice and The development of technology, the current requirements for preparation instructions along with the standard will help to keep this type of development. About 2.1.103 treatment head In the field of diagnostics and thermotherapy has been widely used multi-transducer, in fact in the current applicatio... ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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