GB 9706.206-2020 English PDFUS$339.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.206-2020: Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment Status: Valid
Basic dataStandard ID: GB 9706.206-2020 (GB9706.206-2020)Description (Translated English): Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment Sector / Industry: National Standard Classification of Chinese Standard: C42 Classification of International Standard: 11.040.60 Word Count Estimation: 18,166 Date of Issue: 2020-07-23 Date of Implementation: 2023-05-01 Older Standard (superseded by this standard): GB 9706.6-2007 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.206-2020: Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy 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 2-6.Particular requirements for the basic safety and essential performance of microwave therapy equipment ICS 11.040.60 C42 National Standards of People's Republic of China Replace GB 9706.6-2007 Medical electrical equipment Part 2-6.Microwave therapy Special requirements for basic safety and basic performance of equipment (IEC 60601-2-6.2016, MOD) 2020-07-23 release 2023-05-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsForeword Ⅰ 201.1 Scope, purpose and related standards 1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 3 201.5 General requirements for ME equipment testing 3 201.6 Classification of ME equipment and ME systems 3 201.7 ME equipment identification, marking and documentation 3 201.8 Protection of ME equipment against electric shock 5 201.9 Protection of ME equipment and ME system against mechanical hazards 5 201.10 Protection against unwanted or excessive radiation risks (sources) 5 201.11 Protection against over-temperature and other hazards (sources) 6 201.12 Accuracy of controllers and instruments and protection of dangerous outputs 6 201.13 Dangerous conditions and fault states of ME equipment 7 201.14 Programmable Medical Electrical System (PEMS) 7 201.15 Structure of ME equipment 7 201.16 ME System 8 201.17 Electromagnetic compatibility of ME equipment and ME systems 8 202 Electromagnetic Disturbance-Requirements and Test 8 Appendix 9 Appendix C (informative appendix) ME equipment and ME system marking and labeling requirements guide 10 Appendix AA (informative appendix) Special guidance and explanation 11 Reference 14ForewordGB 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 2-6 of GB 9706. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB 9706.6-2007 "Medical Electrical Equipment Part 2.Special Requirements for the Safety of Microwave Therapy Equipment", and Compared with GB 9706.6-2007, the main technical changes are as follows. --- Deleted the definition of the term "application part" and "radiator" (see 2.1.5, 2.1.102 in the.2007 edition); --- Added the definition of the terms "contact applicator" and "non-contact applicator" (see.201.3.202,.201.3.205); ---Modified the definitions of some terms (see.201.3.203,.201.3.204,.201.3.206,.201.3.207 and.201.308,.2007 edition 2.12.103, 2.1.101, 2.1.103, 2.12.101, 2.12.102); ---Added basic performance requirements (see.201.4.3.11); --- Modified the requirements for non-ionizing radiation symbols in external markings (see.201.7.2.101,.2007 edition 6.1); ---Modified the requirements of the non-contact applicator in the specification requirements (see.201.7.9.2.101, 6.8.2 of the.2007 edition); ---Added the requirements of the corresponding diagram of power output and settings in the technical description (see.201.7.9.2.101); ---Modified the test methods of unwanted radiation and microwave leakage, including modifying the microwave power setting value during the test and the requirements of the test applicator, It is also allowed to use the manufacturer's specified phantom during the test (see.201.10.3, Chapter 31 of the.2007 edition); ---Modified the rated power limit of 250W as a single channel requirement, and increased the power limit requirement for multiple channels (see.201.10.3.103, 31.3 of the.2007 edition); ---Added the temperature requirements of the contact application part (see.201.11.1.2.1); ---Revised the accuracy requirements of microwave power indication, from ±30% to ±20% (see.201.12.1, 50.1 in.2007 edition); ---Added the requirements for the output indicator and the audio signal requirements (see.201.12.4.2.101); ---Clarify that the excitation output requirements are requirements for non-contact applications, and the requirements should also be met after interruption and restoration of the network power supply (see.201.12.4.102, 51.102 in the.2007 edition); ---Added the stop output requirement, it is clear that the microwave output can be manually stopped at any time (see.201.12.4.104); ---Modified the maximum output power requirements, the tolerance was changed from ±30% to not more than 120% of the rated output power (see.201.12.4.105, 50.2 of the.2007 edition); ---Modified the electromagnetic compatibility requirements, changed the test method, and allowed the use of the manufacturer's specified phantom or matching load for the test (See Chapter 36 of 202.4.3,.2007 edition). This part uses the redrafting law to amend and adopt IEC 60601-2-6.2016 "Medical Electrical Equipment Part 2-6.Microwave Therapy Equipment Specific requirements for basic safety and basic performance. The technical differences between this part and IEC 60601-2-6.2016 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.201.2 "Normative Reference Documents". ● Replace IEC 60601-1 with GB 9706.1 modified to adopt international standards; ● Added reference to IEC 60878. ---Added a note under the requirements of.201.10.3 and.201.12.4.103, indicating that this requirement does not apply to the microwave hyperthermia device specified in YY0839 Prepared, in order to coordinate YY0839 stipulates that thermotherapy equipment does not apply to the relevant technical content of this section. This section has made the following editorial changes. ---All terms are represented in bold; ---The term index of the international standard has been deleted. 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 as follows. ---GB 9706.6-1992, GB 9706.6-2007. Medical electrical equipment Part 2-6.Microwave therapy Special requirements for basic safety and basic performance of equipment 201.1 Scope, purpose and related standards In addition to the following, general standard 1) Chapter 1 applies. 201.1.1 *Scope replace. This section specifies the safety requirements for microwave therapy equipment (defined in.201.3.204) used in medical practice. Note. Some of the more important requirements are noted in the "Special Guidelines and Explanations" section, see Appendix AA. Articles corresponding to the notes in Appendix AA or The sub-clauses are marked with an asterisk (*). 201.1.2 Purpose replace. The purpose of this section is to establish specific requirements for the basic safety and basic performance of microwave therapy equipment defined in.201.3.204. 201.1.3 Parallel standards supplement. This section refers to the applicable parallel standards listed in Chapter 2 of the General Standard. IEC 60601-1-2 is applicable after being modified in accordance with Chapter 202.IEC 60601-1-3 is not applicable. 1) The general standard is GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance". 201.1.4 Specific standards replace. This part is a special standard in the GB 9706 series of standards. Special standards can be modified, replaced or deleted, general standards or parallel standards The requirements contained in the standards are applicable to the ME equipment under consideration, and other basic safety and basic performance requirements may also be added. The requirements of specific standards take precedence over the requirements of general standards. In this section, GB 9706.1 is called the general standard. Parallel standards are indicated by their standard numbers. The numbering of the chapters and articles in this part corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this part corresponds to the first Chapter content), or by adding the prefix "20x" to correspond to the applicable parallel standard, where x is the end of the international standard number corresponding to the parallel standard Digits (for example, 202.4 in this part corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-2, and 203.4 in this part corresponds to the parallel The contents of Chapter 4 in the standard IEC 60601-1-3, etc.). Changes to the text of the general standard require the use of the following words. "Replacement" means that the chapters and articles of the general standards or applicable parallel standards are completely replaced by the provisions of this part. "Supplement" refers to the provisions of this section that supplement the requirements of general standards or applicable parallel standards. "Modification" refers to the modification of the general standards or the chapters and articles of the applicable parallel standards in accordance with the description of the provisions of this section. As a supplement to the general standard, the numbering of bars, figures and tables starts from.201.101.However, since the number defined in the general standard changes from 3.1 to 3.139, therefore, the definitions supplemented in this section are numbered starting from.201.3.201.The numbers of the supplementary appendices are AA, BB, etc., and the supplementary column The item numbers are aa), bb), etc. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.206-2020_English be delivered?Answer: Upon your order, we will start to translate GB 9706.206-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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