GB 9706.7-2008 English PDF (GB9706.7-2008)

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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 requiremen...