GB 9706.208-2021 English PDFUS$539.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.208-2021: Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV Status: Valid
Basic dataStandard ID: GB 9706.208-2021 (GB9706.208-2021)Description (Translated English): Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV Sector / Industry: National Standard Classification of Chinese Standard: C43 Word Count Estimation: 27,238 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.208-2021: Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV---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 2-8.Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV ICS 11.040.60 C43 National Standards of People's Republic of China Replace GB 9706.10-1997 Medical electrical equipment Part 2-8.Energy treatment from 10kV to 1MV Special requirements for basic safety and basic performance of X-ray equipment (IEC 60601-2-8.2015, MOD) Issued on 2021-08-10 and implemented on 2023-05-01 State Administration of Market Supervision and Administration 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 3 201.5.5 Power supply voltage, current type, power supply nature, frequency 5 201.6 Classification of ME equipment and ME systems 5 201.7 ME equipment identification, marking and documentation 6 201.8 Protection against electrical injuries from medical electrical equipment 8 201.9 Protection against mechanical damage from ME equipment and ME systems 9 201.10 Protection against unwanted or excessive radiation risks 9 201.11 Protection against over-temperature and other hazards 21 201.12 Accuracy of working data and prevention of dangerous output 21 201.13 Hazardous and fault conditions of medical electrical equipment 21 201.14 Programmable Electrical Medical System 21 201.15 Interpretation of medical electrical equipment 21 201.16 Medical electrical system 21 201.17 Electromagnetic compatibility of medical electrical equipment and medical electrical systems 21 Appendix 22 Reference 23 Table.201.101 Data required in the technical description provides support.201.10 Field and type test compliance 4 Table.201.102 Allowable leakage radiation 9 Table.201.103 Allowable radiation value of X-ray tube assembly with beam limiting device 11 Table.201.104 Measurement Table 20ForewordGB 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.Special requirements for the basic safety and basic performance of electron accelerators with energy from 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 the basic safety and basic performance of the anesthesia workstation; ---Part 2-16.Specific requirements for the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment; ---Part 2-17.Special requirements for the basic safety and basic performance of automatic control brachytherapy after-installation equipment; ---Part 2-18.Specific requirements for the 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.Specific requirements for the 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 Require; ---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.Special 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 2-8 of GB 9706. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB 9706.10-1997 "Medical Electrical Equipment Part 2.Special Requirements for the Safety of Therapeutic X-ray Generating Devices", Compared with GB 9706.10-1997, the main technical changes are as follows. ---Added field test information that should be included in the technical description (see.201.5.4); ---Added the requirements for the external marking of X-ray tubes (see.201.7.2.2); ---Added the requirements for the treatment console outside the treatment room [see.201.10.1.2.105.1]; ---Added the signal requirements for the console [see.201.10.1.2.105.6]; ---Added the requirements for the transition time interval [see.201.10.1.2.105.7]; ---Added the requirements for X-ray tube replacement [see.201.10.1.2.105.8]; --- Increased the limit of absorbed dose (see.201.10.1.2.109.1), the choice of irradiation time or MU (see.201.10.1.2.109.2), Display of preset irradiation time or MU (see.201.10.1.2.109.3), system design (see.201.10.1.2.109.4), irradiation time Or MU display (see.201.10.1.2.109.5), irradiation control (see.201.10.1.2.109.6), moving beam radiotherapy Irradiation control (see.201.10.1.2.109.7). This part uses the redrafting law to amend and adopt IEC 60601-2-8.2015 "Medical Electrical Equipment Part 2-8.Energy is 10kV Specific requirements for the basic safety and basic performance of 1MV therapeutic X-ray equipment". The technical differences between this part and IEC 60601-2-8.2015 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. ● Replace IEC 60601-2-1.2009 with GB 9706.201-2020, which is modified to adopt international standards. ● Replace IEC 61217 with GB/T 18987-2015, which is equivalent to adopting international standards. This section has made the following editorial changes. --- Deleted some informative "Notes"; ---The term index at the end of the international standard text has been deleted. Please note that some of the 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 9706.10-1997. Medical electrical equipment Part 2-8.Energy treatment from 10kV to 1MV Special requirements for basic safety and basic performance of X-ray equipment 201.1 Scope, purpose and related standards In addition to the following, Chapter 1 of the general standard applies. 201.1.1 Scope replace. This part of GB 9706 is applicable to therapeutic X-ray equipment with AC power supply and nominal X-ray tube voltage of 10kV~1MV The basic safety and basic performance. Hereinafter referred to as ME equipment. Note. This section covers distance radiotherapy and brachytherapy. If a chapter or sub-clause is clearly stipulated as only applicable to ME equipment, or only applicable to ME systems, the chapter or sub-clause The title and content of the chapter will be explained. If this is not the case, then the clause or sub-clause applies to both ME equipment and ME system. 201.1.2 Purpose replace. The purpose of this section is to develop specific basic safety and basic performance of therapeutic X-ray equipment. It includes accuracy on performance And repeatability requirements, these requirements are related to the radiation quality and quantity of ionizing radiation generated, so this is also a safety consideration problem. 201.1.3 Parallel standards Supplement. This section refers to the parallel standards listed in Chapter 2 of the General Standards and.201.2 of this section. GB 9706.12 and IEC 60601-1-10 are not applicable. All other published parallel standards in the GB 9706 series follow the release And apply. 201.1.4 Specific standards replace. In the GB 9706 series, the special standards can be modified, replaced or deleted according to the special ME equipment under consideration, the general standards and parallel standards The requirements contained in the standards. And can add other basic safety and basic performance requirements. The requirements of specific standards take precedence over the requirements of general standards. In this section, GB 9706.1-2020 is referred to as the general standard. Parallel standards are represented by their respective standard numbers. The numbering of chapters and articles in this part is prefixed with "201" to correspond to the general standard (for example,.201.1 in this part corresponds to the first chapter of the general standard). Chapter), or add the prefix “20×” to correspond to the applicable parallel standard, where “×” is the last digit of the international standard number corresponding to the parallel standard (example For example, 202.4 in this part corresponds to the content of Chapter 4 in the collateral standard YY9706.102, and 203.4 in this part corresponds to the collateral standard The contents of Chapter 4 in GB 9706.103, etc.). ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.208-2021_English be delivered?Answer: Upon your order, we will start to translate GB 9706.208-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB 9706.208-2021_English with my colleagues?Answer: Yes. 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