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GB 9706.7-2008: Medical electrical equipment -- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
GB 9706.7-2008
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
Foreword
All 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 60601-2-5.2000
introduction
This 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 methods
2 Terms and Definitions
In 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 gene...