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Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
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Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
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Basic data | Standard ID | GB 9706.9-2008 (GB9706.9-2008) | | Description (Translated English) | Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.40.55; 17.140.50 | | Word Count Estimation | 45,437 | | Date of Issue | 2008-03-24 | | Date of Implementation | 2009-01-01 | | Older Standard (superseded by this standard) | GB 9706.9-1997 | | Quoted Standard | GB 9706.1-2007; YY 0505-2005; IEC 60601-1-4: 2000; GB 4208-1993; GB/T 16540-1996; GB/T 16846-2008; YY/T 0316-2003; IEC 61161: 2006 | | Adopted Standard | IEC 60601-2-37-2001, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 5, 2008 (No. 118 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies 2. 1. 145 dedicated ultrasound diagnostic equipment as defined by special security requirements. This standard does not include ultrasound treatment equipment, however and treatment devices together, using ultrasound on human tissue imaging equipment included. | GB 9706.9-2008: Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment.Part 2-37. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
ICS 11.40.55; 17.140.50
C41
National Standards of People's Republic of China
GB 9706.9-2008/IEC 60601-2-37.2001
Replacing GB 9706.9-1997
Medical electrical equipment Part 2-37.
Ultrasound diagnostic and monitoring equipment requirements for the safety
(IEC 60601-2-37.2001, 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 standard IEC 60601-2-37.2001 "Medical Electrical Equipment Part 2-37. Ultrasonic diagnostic and monitoring equipment for Private
With the requirements "and Revision 1.2004, Revision 2.2005 revision of the two pieces.
This standard replaces GB 9706.9-1997 "Medical electrical equipment ultrasonic diagnostic requirements for the safety and monitoring equipment."
This major change compared to the standard GB 9706.9-1997 follows.
--- name and standard IEC 60601-2-37.2001 exactly the same;
--- in Chapter 2, "Terms and definitions" terminology mainly relates to the increase Acoustic safety, increase the symbol table;
--- an increase of 3.101 "basic performance" in Chapter 3, "General Requirements";
--- in Chapter 6, "to identify, mark and File" to 6.1 "device or device component external tag" and 6.3 "and the instrument control means
Label "or alternatively, the increase in part 6.8.3." "Adds the" required acoustic output report table "Technical specification;
--- deleted the original standard Chapter 17, "isolation" in the discharge requirements for protective effects of cardiac defibrillator;
--- Chapter 19, "Continuous leakage and patient auxiliary current" and Chapter 20, "dielectric strength" employed in the salt solution increases Applications
Part of the test;
--- Chapter 35 "acoustic energy (including ultrasound)," added the mark of an ultrasound transmitter, accuracy sound output data, and acoustic output freeze
Risk assessment required safety-related parameters;
--- In Chapter 36, "electromagnetic compatibility", the particularity of ultrasound diagnostic equipment increased in part;
--- in Chapter 42, "overtemperature" measure the surface temperature of the transducer increases to 42.3 or alternatively the ultrasound transducer part;
In Chapter 44 --- "flooding, a liquid spill, leak, moisture, into the liquid, cleaning, disinfection and sterilization" is added to 44.6 "inlet" or alternatively
A part of the contents of the original standard normal ultrasonic transducer is modified in claim IPX1 IPX4;
--- increase accuracy in Chapter 50, "the accuracy of the job data", the output of sound data and transesophageal echocardiography transducer temperature display
Add the technical requirements;
--- In Chapter 51, "prevent the risk of output", the real-time display of MI MI, thermal index TI and other issues involving the safety of ultrasound
Conditions and increased technical content requirements;
--- an increase of two normative appendix, seven informative annex, appendix correct understanding of the content standards and fully implement is indispensable
Less.
Standard text in the preceding article number raises "" sign indicates that the provisions in the Appendix BB in further explanation.
The term standard GB 9706.1 chapter 2 and defined, they appear in bold represents the standard texts.
This standard appendix Appendix AA and DD are normative, Annex BB, the CC Appendices, Appendix EE, the FF Appendices, Appendix GG,
Appendices Appendix HH and II are informative appendix.
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. Wang Zhijian, busy Ashmore.
This standard supersedes the previous editions are.
--- GB 6385-1986;
--- GB 9706.9-1997.
GB 9706.9-2008/IEC 60601-2-37.2001
Introduction
In this specific standard, the ultrasonic diagnostic apparatus for other than the common standard specifies additional safety requirements.
Guidance is given and the specific explanation of the principle in the following standard.
An understanding of these requirements will not only help the cause of the proper use of this specific standard, but also to speed up changes in clinical practice or technology based on
Result of the development of the standard in a timely manner to make any necessary revisions.
The general guiding principles and instructions
Methods and ideas employed in drafting standard diagnostic ultrasound dedicated safety equipment, currently used with other diagnostic devices such as X
IEC 60601-2 series of standards line equipment and nuclear magnetic resonance equipment consistent.
In each case, the purpose of the safety probe is standard in the art of diagnosis, with the increase of energy level, but also increases significantly the output
Illustrates the complexity of the indicator and/or controller requirements. Therefore, all sort of diagnostic equipment, the operator's responsibility is to understand design
The risk of equipment output, and take appropriate action to ensure at the same time to obtain the necessary diagnostic information in patients with the least dangerous bear.
This standard does not apply to an ultrasonic treatment device. This standard applies to the body structure using ultrasound and other medical instruments, as for
Image and device diagnostics.
GB 9706.9-2008/IEC 60601-2-37.2001
Medical electrical equipment Part 2-37.
Ultrasound diagnostic and monitoring equipment requirements for the safety
The first chapter outlines
Except for the following General Standard Benpian Chapter shall apply.
1 Scope and purpose
In addition to following the terms of the common standards in this chapter are applicable.
1.1 Scope
increase.
This standard specifies the specific requirements for the safety of the ultrasonic diagnostic apparatus as defined 2.1.145.
This standard does not include an ultrasonic therapy device; however, connected to the treatment device, human tissue using ultrasound imaging apparatus comprising
Included.
1.2 Purpose
Alternative.
Purpose of this standard is to specify specific requirements for each of the ultrasonic diagnostic apparatus and safety and security aspects related directly.
1.3 Specific Standard
increase.
This specific standard revised and supplemented following a standard publications, referred to as the "General Standard" hereinafter.
GB 9706.1-2007 Medical Electrical Equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
YY0505-2005 General Requirements for Safety Medical Electrical Equipment Part 1-2. Collateral Standard. EMC requirements and tests
(IEC 60601-1-2.2001, IDT)
IEC 60601-1-4.2000 Medical Electrical Equipment Part 1-4. General requirements for safety Collateral Standard. Programmable Medical Electronics
system
This medium-length specific standard, chapter and section numbering corresponding 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 increased FIG numbered starting from 101, additional annexes letters AA, BB, etc. expressed in terms of increased AA),
bb) and the like represent.
Described principles involved chapter of heater () said that the principle of explanation can be found in the informative annex BB, the appendix can be used to determine BB
Seeking relevant content, but may not be used to determine additional testing requirements.
In no specific standard corresponding to articles, when the number of chapters strip, without modification articles, Chapter strip using a common standard.
In any part of a universal standard, although related, but not ready to adopt, such a statement is given in the execution of the specific standard.
Standard requires specialized replaced or changed requirements of common standards or criteria, which take precedence over the corresponding requirements of common standards.
1.3.101 relevant national and international standards
GB 4208-1993 shell protection (IP code) (eqv IEC 60529. 1989)
Ultrasound field characteristics GB/T 16540-1996 acoustic frequency in the range of 0.5 ~ 15MHz and hydrophone measurement method (eqv
IEC 61102.1991)
GB 9706.9-2008/IEC 60601-2-37.2001
GB/T 16846-2008 medical ultrasonic diagnostic apparatus Publication claim acoustic output (IEC 61157.1992, IDT)
YY/T 0316-2003 medical device risk management applications for medical devices (ISO 14971.2000, IDT)
IEC 61161.2006 and ultrasound radiation force balance performance sound power measurement requirements
2 Terms and Definitions
In addition to the following, common standards in this chapter applies.
Increase definitions.
2.1.101
Ultrasonic attenuation coefficient for the tissue between the sound source and the calculation of the specific point.
Symbols. α
Unit. MHz decibels per centimeter (dBcm-1MHz-1)
NOTE. acoustic attenuation coefficient is specific to this standard change ratio of the frequency of the acoustic attenuation coefficient in terminology medium (tissue), i.e. the slope of the frequency variable.
Diagnostic ultrasound in the frequency range, the coefficient of soft tissue approximately constant.
2.1.102
[See GB/T 16540 3.4.2, Change]
Units. megahertz (MHz)
2.1.103
After considering the attenuation and from the transducer at a certain distance, the acoustic output power value is given by the following formula.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
After Pα --- attenuated output power in milliwatts (mW);
--- output power P measured in water, milliwatts (mW).
Symbol. Pα
Units. milliwatts (mW)
2.1.104
And at a particular point, the peak value of sound pressure sparse after considering the attenuation is given by the following formula.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
Unit. megapascals (MPa)
GB 9706.9-2008/IEC 60601-2-37.2001
2.1.105
After considering the attenuation at a particular point and the sound pulse average intensity value, is given by.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
IPA average sound pulse (z) --- intensity measured in water, in units of watts per square centimeter (Wcm-2).
Symbols. Ipa, α
Units. watts per square centimeter (Wcm-2)
2.1.106
After considering the attenuation and the value at a particular point, the pulse sound intensity integrals given by.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
After Ipi, α --- sound intensity integral decay pulse, in units of millijoules per square centimeter (mJcm-2);
IPI --- acoustic pulse in the water the stronger points measured in units of millijoules per square centimeter (mJcm-2).
Symbols. Ipi, α
Unit. millijoules per square centimeter (mJcm-2)
2.1.107
After considering the attenuation and, in particular at a distance z, intensity spatial peak temporal average acoustic values, is given by.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
Izpta (z) --- spatial average intensity measured in water at a certain distance z peak time milliwatts per square centimeter
(MWcm-2).
Symbols. Izpta, α (z)
Unit. milliwatt per square centimeter (mWcm-2)
2.1.108
And the average intensity value after considering the attenuation at a particular point in time, is given by the following formula.
Where.
--- acoustic attenuation coefficient [alpha] in decibels per centimeter MHz (dBcm-1MHz-1);
Z --- the distance between a sound source and a particular point in centimeters (cm & lt);
GB 9706.9-2008/IEC 60601-2-37.2001
Ita, α (z) --- after the decay time average intensity in milliwatts per square centimeter (mWcm-2);
ITA (z) --- water measured time average intensity in milliwatts per square centimeter (mWcm-2).
Symbols. Ita, α (z)
Unit. milliwatt per square centimeter (mWcm-2)
2.1.109
Perpendicular to the axis of the area of beam collimation of the specific plane, the area is larger than the integrated intensity of the acoustic pulse plane acoustic pulse intensity integral value of the
Coefficient of a specified point composition.
[See GB/T 16540-1996 3.7, Change]
Note. For measurement purposes, may be considered integral to the sound intensity pulsed acoustic pressure pulse is proportional to the square of the points.
2.1.110
Connecting the far field of several different distances, the straight line between the point of maximum intensity integral acoustic pulse, for the purpose of collimation, the wire may be administered
Movies to the end face of the ultrasonic transducer.
[See GB/T 16540-1996 3.6, Change]
2.1.111
Heat index for the fetus (six to nine months) or newborn baby's head (via fontanelle) or the like, in these applications the ultrasonic beam penetrates
Soft tissue, the focus area in close vicinity of bone.
Symbol. TIB
Unit. None
Note. The method for determining bone thermal index, see DD. 4.2 and DD. 5.2.
2.1.112
In scan mode, the sensitive surface of the transducer in the scanning plane is defined as the width of the output power of the emitted region of 1cm.
Symbols. P1
Units. milliwatts (mW)
2.1.113
Is equal to 1.5 times the equivalent diameter of the numerical aperture, is given by.
Z bp = 1.5Deq
Where.
DEQ --- equivalent aperture diameter.
Symbol. z bp
Unit. centimeters (cm)
2.1.114
Combination of devices operating mode of a single mode of operation of the above formed.
[See GB/T 16846-2008 3.6]
2.1.115
Application of the heat index, such as the skull of an adult or a minor and the like, in these applications the ultrasonic beam penetrates into the body near the beam
GB 9706.9-2008/IEC 60601-2-37.2001
Bone tissue at the mouth.
Symbol. TIC
Unit. None
Note. The method for determining the skull heat index, see DD. 4.3.
2.1.116
Depending on the boot, to select or change new patient application from a non-fetus fetus applied to the control terminal, the incoming ultrasonic diagnostic apparatus specified
status.
2.1.117
After the beam along the collimation axis, to attenuate the output power and the attenuation -12dB plane is determined from the output beam size of the acoustic intensity pulse integrator
The product of the maximum distance between the plane.
Symbol. z b
Unit. centimeters (cm)
2.1.118
, The output power and the attenuation of the attenuated sound intensity spatial peak temporal average of the product both in the small 1cm2, equal to or greater than the entire
Obtain the maximum value of 1.5 times the aperture diameter equivalent distance.
Symbol. z s
Unit. centimeters (cm)
Note. in this specific standard, the use of 3.41 with respect to the specified plane 16540-1996 space, from GB/T average sound intensity peak time limiting
Is defined, here, the spatial peak time average sound intensity is attenuated by spatial peak temporal average acoustic intensity replaced.
2.1.119
The ultrasonic diagnostic apparatus or the ultrasonic transducer is determined incentives ultrasonic transducer element group operating mode is only applicable to a diagnostic
the way.
[See GB/T 16846-2008 3.7]
2.1.120
Deq≡ 4π
Aap Sang rt
Where.
Symbol. Deq
Unit. centimeters (cm)
NOTE. This formula gives the diameter of the circle is equal to the area of -12dB beam output area, for calculating the thermal index skull and soft tissue thermal index.
2.1.121
Represented by a power of the sound intensity, the value z beam area at a distance, is given by.
Aeq (z) ≡
Pα
Izpta, α (z)
= PIzpta (z)
Where.
P [alpha] --- attenuated output power at a certain distance z milliwatts (mW);
GB 9706.9-2008/IEC 60601-2-37.2001
Izpta, α (z) --- spatial peak temporal average acoustic intensity after attenuation at a certain distance z milliwatts per square centimeter (mWcm-2);
P --- output power in milliwatts (mW);
Izpta (z) --- the average sound intensity in the space at a certain distance z peak time milliwatts per square centimeter (mWcm-2);
Z --- the distance between a sound source and a particular point in centimeters (cm).
Symbol. Aeq (z)
Unit. square centimeter (cm2)
2.1.122
Equivalent beam area represented by the value of the beam diameter at the distance of the sound z, is given by.
Aeq (z Sang)
Where.
AEQ (z) --- equivalent beam area;
Z --- the distance between a particular point and the sound source.
Unit. centimeters (cm)
2.1.123
Determining the magnitude of the acoustic output device of the embodiment, it does not depend on direct operator control.
2.1.124
Displaying a representation of a parameter of the potential biological effects of cavitation.
NOTE. The method of determining the mechanical parameters, see DD. 2.2.
2.1.125
The clinical application of ultrasound equipment have more than one.
2.1.126
One mode of operation of the ultrasonic diagnostic apparatus, one set of acoustic excitation pulse sequence of an ultrasound scan line is located on the same acoustic path.
[See GB/T 16846-2008 3.12, Change]
2.1.127
[See GB/T 16846-2008 3.13, Change]
Symbol. Aaprt
Unit. square centimeter (cm2)
2.1.128
An ultrasonic beam size (-12dB beam pulse width) in a particular direction, the transducer output end face, and perpendicular to the axis of the collimated beam.
[See GB/T 16846-2008 3.14, Change]
The output beam size.
Note 2. for contact transducer, which may be considered equal to the size of the size of the radiation-sensitive element.
GB 9706.9-2008/IEC 60601-2-37.2001
Symbol. X, Y
Unit. centimeters (cm)
2.1.129
Under specified conditions specified medium (preferably water), by an ultrasonic transducer to the free field radiation is approximately the temporal average power.
Symbol. P
Units. milliwatts (mW)
2.1.130
In the acoustic wave repetition period, the absolute value of the maximum negative instantaneous sound pressure.
[See GB/T 16846-2008 3.34, Change]
Unit. megapascals (MPa)
2.1.131
When clinical information necessary for collection, it is recommended to avoid high radiation levels first, followed by the principle of time certainly avoid long exposure.
2.1.132
Pulse average intensity
Symbol. Ipa
Units. watts per square centimeter (Wcm-2)
2.1.133
The maximum distance between the two surfaces is equal to the specified score.
[See GB/T 16846-2008 3.18, Change]
Unit. centimeters (cm)
2.1.134
When the sound intensity of the acoustic pulse the time integral value of 10% and 90% of the integral intensity acoustic pulse, is 1.25 times the time interval between two points.
[See GB/T 16540-1996 3.26, Change]
Unit. seconds (s)
2.1.135
Sound field instantaneous sound intensity at a specific point in the entire integration time acoustic pulse waveform.
[See GB/T 16540-1996 3.27]
Symbol. Ipi
Unit. millijoules per square centimeter (mJcm-2)
2.1.136
Sound field at a particular point of the instantaneous sound pressure squared, integrated over the entire time acoustic pulse waveform.
GB 9706.9-2008/IEC 60601-2-37.2001
[See GB/T 16540 3.29]
Unit. Pa second squared (Pa2s)
2.1.137
The reciprocal of the time interval between two adjacent pulses of sound.
Unit. hertz (Hz)
2.1.138
One mode of operation of the ultrasonic diagnostic apparatus, one set of acoustic excitation pulse sequence of an ultrasound scan line is located on the different acoustic paths.
[See GB/T 16846-2008 3.21, Change]
2.1.139
A heat index of soft tissue.
Symbol. TIS
Unit. None
Note 1. The method for determining the soft tissue thermal index, see DD. 5.1.
Note 2. In this standard, including soft tissue other than bone tissue, all human tissues and body fluids.
2.1.140
In the specified plane, the transducer from the specified average sound intensity at the maximum distance of z.
[See GB/T 3.41 16540-1996, changing]
Symbol. Izpta (z)
Unit. milliwatt per square centimeter (mWcm-2)
Note. In this standard, with respect to the specified plane, restrictive definition of the GB/T 3.41 of the 16540-1996.
2.1.141
Strong instantaneous sound time-averaged sound field in a particular point.
[See GB/T 3.45 16540-1996, changing]
Symbol. Ita (z)
Unit. milliwatt per square centimeter (mWcm-2)
2.1.142
At a specified point of the attenuated output power with the tissue model under specified conditions, so that the temperature rises after the decay of the output power required 1 ℃
Ratio rate value.
Symbol. TI
Unit. None
2.1.143
Transducer housing, all the electronic circuits connected to the housing and all the liquid is electrically connected to an integrated ultrasonic transducer probe and the host
Cable.
[See GB/T 16846-2008 3.22]
GB 9706.9-2008/IEC 60601-2-37.2001
2.1.144
A specified set of transducers beam forming characteristics (emission by the pore size, the shape of apodization, the aperture across the relative timing/delay mode phase sequence
Type, focal length and determines the direction specified) and the specified composition, but a shape of the fixed amplitude level variable excitation waveform.
2.1.145
For medical diagnosis using ultrasound on the human body for medical electrical equipment monitoring examination.
NOTE. See GB/T 16846-2008 3.11 definitions, medical diagnostic ultrasound apparatus (or system). Commonwealth ultrasound apparatus main assembly and the transducer forms a
A complete diagnostic system.
2.1.146
In the ultrasonic frequency range, converts electrical energy into mechanical energy and/or means convert mechanical energy into electrical energy.
2.1.147
Maintaining the necessary performance characteristics remaining within acceptable limits of risk.
[YY0505-2005, defined 2.210]
Note. See also YY0505-2005 of 3.201.2.
2.101 symbol table
Sound attenuation coefficient α
CMI normalization coefficient
Deq equivalent diameter of aperture
Ipa pulse average intensity
Ipa, the average intensity decay pulse α
Ipi pulse sound intensity integral
After Ipi, α integral decay pulse sound intensity
Ita (z) times average intensity
After Ita, α (z) average intensity decay time
Izpta (z) spatial peak temporal average acoustic intensity
After Izpta, α (z) attenuating spatial peak temporal average acoustic intensity
MI MI
Output power P
After Pα attenuated output power
P1 bounded output power
TI Heat Index
TIB bone thermal index
GB 9706.9-2008/IEC 60601-2-37.2001
TIC skull Heat Index
TIS soft tissue thermal index
Z from the specified point to the sound source
Z b TIB depth
Z bp breakpoint depth
Z s TIS depth
3 General requirements
In addition to the following, common standards of this chapter applies.
3.101 basic performance
Note. The definition of ultrasound diagnostic equipment is expected to see 2.1.145.
The following are the basic performance characteristics of the ultrasonic diagnostic apparatus of potential hazards.
--- wave noise, artifacts, distortion in the image or the display error of the digital values, which can not be attributed to physiological effects and may
Changing diagnosis;
--- inaccuracies associated with the diagnosis of numeric values carried out by the display;
Inaccurate display --- related to the safety instructions;
--- unintended or excessive ultrasound output;
--- unintended or excessive transducer assembly to generate surface temperature;
--- contemplated cavity using a transducer assembly, unintended motion or uncontrollable generation.
We should assess the potential hazards In some cases, the need to repeat ultrasound examination, e.g., intracavity probe of heart disease and should
Test.
6 to identify, mark and file
In addition to the following, common standards of this chapter applies.
External marking d...
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