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GB 9706.205-2020: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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| GB 9706.205-2020 | English | 489 |
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Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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GB 9706.205-2020
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Basic data | Standard ID | GB 9706.205-2020 (GB9706.205-2020) | | Description (Translated English) | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.40.60 | | Word Count Estimation | 26,285 | | Date of Issue | 2020-07-23 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB 9706.7-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.205-2020: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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Medical electrical equipment--Part 2-5.Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
ICS 11.40.60
C41
National Standards of People's Republic of China
Replace GB 9706.7-2008
Medical electrical equipment
Part 2-5.Ultrasound physical therapy equipment
Special requirements for basic safety and basic performance
(IEC 60601-2-5.2009, MOD)
Issued on 2020-07-23 Implemented on 2023-05-01
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
Introduction Ⅲ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 5
201.5 General requirements for ME equipment testing 5
201.6 Classification of ME equipment and ME systems 6
201.7 *ME equipment identification, marking and documentation 6
201.8 *ME equipment protection against electric shock 7
201.9 Protection of ME equipment and ME systems against mechanical hazards 7
201.10 Protection against unwanted or excessive radiation risks (sources) 7
201.11 Protection against over-temperature and other hazards (sources) 8
201.12 Accuracy of controllers and instruments and protection against dangerous outputs 10
201.13 Dangerous conditions and fault states of ME equipment 12
201.14 Programmable Medical Electrical System (PEMS) 12
201.15 Structure of ME equipment 12
201.16 ME System 12
201.17 *Electromagnetic compatibility of ME equipment and ME system 12
202.6 Electromagnetic compatibility 13
Appendix 14
Appendix AA (informative appendix) special guide and principle explanation 15
Appendix BB (informative appendix) Example of test arrangement for surface temperature measurement of external transducer components 19
Reference 21
Foreword
GB 9706 "Medical Electrical Equipment" is divided into the following parts.
---Part 1.General requirements for basic safety and basic performance;
---Part 1-3.General requirements for basic safety and basic performance Parallel standard. Radiation protection of diagnostic X-ray equipment;
---Part 2-1.Specific requirements for the basic safety and basic performance of electron accelerators with an energy of 1MeV to 50MeV;
---Part 2-2.Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
---Part 2-3.Special requirements for basic safety and basic performance of shortwave treatment equipment;
---Part 2-4.Special requirements for the basic safety and basic performance of cardiac defibrillators;
---Part 2-5.Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;
---Part 2-6.Special requirements for the basic safety and basic performance of microwave therapy equipment;
---Part 2-8.Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;
---Part 2-11.Special requirements for the basic safety and basic performance of gamma beam therapy equipment;
---Part 2-12.Special requirements for the basic safety and basic performance of intensive care ventilators;
---Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations;
---Part 2-16.Specific requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
---Part 2-17.Special requirements for basic safety and basic performance of automatic control brachytherapy after-installation equipment;
---Part 2-18.Specific requirements for basic safety and basic performance of endoscopic equipment;
---Part 2-19.Special requirements for basic safety and basic performance of infant incubators;
---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;
---Part 2-24.Special requirements for basic safety and basic performance of infusion pumps and infusion controllers;
---Part 2-25.Special requirements for basic safety and basic performance of electrocardiograph;
---Part 2-26.Special requirements for the basic safety and basic performance of EEG machines;
---Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment;
---Part 2-28.Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;
---Part 2-29.Specific requirements for the basic safety and basic performance of radiotherapy simulators;
---Part 2-36.Special requirements for the basic safety and basic performance of in vitro lithotripsy equipment;
---Part 2-37.Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;
---Part 2-39.Special requirements for the basic safety and basic performance of peritoneal dialysis equipment;
---Part 2-43.Special requirements for the basic safety and basic performance of interventional X-ray equipment;
---Part 2-44.Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;
---Part 2-45.The basic safety and basic performance of mammography equipment and mammography stereotaxic devices
Claim;
---Part 2-54.Special requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;
---Part 2-60.Special requirements for basic safety and basic performance of dental equipment;
---Part 2-63.Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;
---Part 2-65.Specific requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;
---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system.
This part is part 2-5 of GB 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB 9706.7-2008 "Medical Electrical Equipment Part 2-5.Special Requirements for the Safety of Ultrasonic Physical Therapy Equipment", and
Compared with GB 9706.7-2008, the main technical changes are as follows.
---Added "Basic safety and basic performance special requirements" (see.201.1.1);
---Added "Special requirements for basic safety and basic performance" (see.201.1.2);
---Modified the "normative references" (see.201.2, 1.5 of the.2008 edition);
---Added the "increased basic performance requirements" (see.201.4.3.11);
--- Added "Patient Auxiliary Current Measurement" (see.201.8.7.4.8);
---Added "dielectric strength" (see.201.8.8.3);
--- Added "ultrasonic energy" (see.201.10.101);
---Added the "application part that does not provide heat to the patient" (see.201.11.1.2.2);
---Modified "measurement" (see.2011.11.1.3, 42.3 of the.2008 edition);
--- Added "Accuracy of Controllers and Instruments" (see.201.12.1);
--- Added "Programmable Medical Electrical System (PEMS)" (see.201.14);
--- Added "ME system" (see.201.16);
--- Added "Examples of surface temperature measurement arrangements for external transducer components" (see Appendix BB).
This part uses the redrafting law to amend and adopt IEC 60601-2-5.2009 "Medical Electrical Equipment Part 2-5.Ultrasonic Physical Therapy Equipment
Specific requirements for basic safety and basic performance.
The technical differences between this part and IEC 60601-2-5.2009 and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in the chapter "Normative Reference Documents", and the specific adjustments are as follows.
● Removed IEC 60601-1-2.2007 (see.201.2).
This section also made the following editorial changes.
--- Deleted the "index of defined terms".
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part is proposed and managed by the State Drug Administration.
The previous releases of the standards replaced by this part are.
---GB 6386-1986;
---GB 9706.7-1994, GB 9706.7-2008.
Introduction
This special standard specifies additional safety and performance requirements for ultrasonic physical therapy equipment on the basis of the general standard.
This special standard considers the content of YY/T 0750-2009.
The requirements follow the relevant test specifications.
For important requirements in Appendix AA, the principle description is given when necessary. Understanding the reasons for these requirements will not only help
The use of this special standard can also speed up any necessary revisions to the standard in a timely manner based on changes in clinical practice or the results of technological development.
But the appendix is not part of the standard requirements.
Chapters and articles with principle descriptions are marked with an asterisk (*) in the upper corner after the clause number.
Medical electrical equipment
Part 2-5.Ultrasound physical therapy equipment
Special requirements for basic safety and basic performance
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard applies.
201.1.1 Scope
Substitute.
This section applies to the basic safety and basic performance of ultrasound physiotherapy equipment defined in.201.316.Hereinafter referred to as ME equipment.
This section only relates to ultrasonic physiotherapy equipment that uses a single plane non-focusing circular transducer as the treatment head, and the static sound beam generated by it is vertical.
Straight to the end face of the treatment head.
This part also applies to ultrasound physiotherapy equipment that compensates or relieves disease, injury or disability.
In the case of a combined device (for example, the device has an additional function or application part of electrical stimulation), this type of device should also comply with the added
Add the provisions of the special standards involved in the functional safety requirements.
If the chapter or article is specifically expected to apply only to ME equipment, or only to ME systems, it is stated in the title and content of the chapter or article
Bright. If no instructions are given, the chapter or article is applicable to ME equipment and ME systems.
The inherent hazards in the expected physiological functions of ME equipment or ME systems within the scope of this part, except for the general standards 7.2.13 and 8.4.1
In addition, it is not included in the special requirements of this section.
Note. See 4.2 of the general standard.
This specific standard does not apply to.
---Using ultrasonic-driven equipment (for example, equipment used in surgery and dentistry);
---Using focused ultrasound pulse waves to crush condensate such as kidney or bladder stones (lithography machine) (see GB 9706.22);
---Using focused ultrasound ultrasound physiotherapy equipment.
201.1.2 Purpose
Substitute.
The purpose of this special standard is to specify the basic safety and basic performance requirements of ultrasound physiotherapy equipment as defined in.201.316.
201.1.3 Parallel standards
increase.
The applicable parallel standards involved in this special standard are listed in Chapter 2 of the general standard and.201.2 of this special standard.
YY0505 applies after revising Chapter 202, and all other published parallel standards in the GB 9706 series adopt its latest version.
201.1.4 Specific standards
Substitute.
In the GB 9706 series, as long as it is applicable to specific ME equipment, the specific standards can modify, replace or delete the requirements in the general standards.
Requirements, other basic safety and basic performance requirements can also be added.
The requirements of specific standards take precedence over general standards.
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