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GB 9706.9-2008 English PDF

GB 9706.9: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 9706.9-2008	RFQ	ASK	5 days	Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment	Obsolete
GB 9706.9-1997	599	Add to Cart	4 days	Medical electrical equipment--Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment	Obsolete

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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Older Standard (superseded by this standard): GB 9706.9-1997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

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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 specif......

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