GB 9706.211-2020 English PDFUS$709.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.211-2020: Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment Status: Valid
Basic dataStandard ID: GB 9706.211-2020 (GB9706.211-2020)Description (Translated English): Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment Sector / Industry: National Standard Classification of Chinese Standard: C43 Classification of International Standard: 11.040.60 Word Count Estimation: 38,31 Date of Issue: 2020-12-24 Date of Implementation: 2023-05-01 Older Standard (superseded by this standard): GB 9706.17-2009 Quoted Standard: IEC 60601-1-3-2008; IEC TR 60788-2004; IEC 61217 Adopted Standard: IEC 60601-2-11-2013, MOD Regulation (derived from): National Standard Announcement No. 31 of 2020 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration Summary: This standard applies to the basic safety and basic performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment, hereinafter referred to as ME equipment. If a chapter or article clearly states that it is only applicable to ME equipment or ME systems, the title and content of the chapter or article will be explained. If this is not the case, this chapter or article applies to ME equipment and ME systems. Except for 7.2.13 and 8.4.1 of the general standard, there are no specific requirements in this standard for the hazards caused by the expected physiological effects of ME equipment or ME systems within the scope of this standard. GB 9706.211-2020: Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam 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 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment ICS 11:040:60 C43 National Standards of People's Republic of China Replace GB 9706:17-2009 Medical electrical equipment Part 2-11: Gamma beam therapy equipment Special requirements for basic safety and basic performance (IEC 60601-2-11:2013, MOD) Released on 2020-12-24 Implemented on 2023-05-01 State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsForeword 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 Protection of ME equipment against electric shock risk 11 201:9 Protection of ME equipment and ME systems against mechanical hazards 12 201:10 Protection against unwanted or excessive radiation risks (sources) 13 201:11 Protection against over-temperature and other hazards (sources) 26 201:12 Accuracy of controllers and instruments and protection against dangerous outputs 27 201:13 Dangerous situations and fault states of ME equipment 27 201:14 Programmable Medical Electrical System (PEMS) 27 201:15 Structure of ME equipment 27 201:16 ME System 27 201:17 Electromagnetic compatibility of ME equipment and ME systems 27 Appendix 32 Appendix B (informative appendix) Test sequence 33ForewordGB 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 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 short-wave 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 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: Specific 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: Specific 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: Specific 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: Specific 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: Specific 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 2-11 of GB 9706: This section was drafted in accordance with the rules given in GB/T 1:1-2009: This part replaces GB 9706:17-2009 "Medical electrical equipment Part 2: Special requirements for the safety of gamma beam therapy equipment", and Compared with GB 9706:17-2009, the main technical changes are as follows: ---Added some terms and definitions (see:201:3, Chapter 2 of the:2009 edition); ---Modified the requirements for the transmission time of MSSR equipment (see:201:10:2:2:2:2, 29:1:1:2 in the:2009 edition); ---Added relevant requirements for MSSR with removable helmets (see:201:10:2:2:12); ---Added the relevant requirements of the programmable medical electrical system (PEMS) (see:201:14); ---Modified some test methods (see:201:9,:201:10:2:5:4, Chapter 22, 29:4:4 of the:2009 edition): This part uses the redrafting law to amend and adopt IEC 60601-2-11:2013 "Medical Electrical Equipment Part 2: Gamma Beam Therapy Equipment" Preparation of special requirements for basic safety and basic performance: The technical differences between this part and IEC 60601-2-11:2013 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 (see:201:2 and related provisions) with GB 9706:1, which is modified to adopt international standards: This section has made the following editorial changes: ---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 versions of the standards replaced by this part are as follows: ---GB 9706:17-1999, GB 9706:17-2009:IntroductionUsing gamma beam therapy equipment for the purpose of radiotherapy, if the ME equipment that gives the patient the required dose fails or the ME If the design of the equipment fails to meet the electrical and mechanical safety standards, the patient may be at risk: If the ME equipment itself is not sufficiently protected or Inappropriate design of the treatment room, ME equipment may also endanger nearby personnel: The requirements determined in this section serve as the manufacturer's basis for the design and manufacture of gamma beam therapy equipment::201:10:2 specifies the tolerance limit Limits, when these limits are exceeded, the interlocking device should prevent, interrupt or terminate the irradiation to avoid unsafe conditions: Type test (completed by the manufacturer) Or on-site inspection (not necessarily completed by the manufacturer) is stipulated in each requirement: 201:10:2 does not attempt to determine the best performance requirements for gamma beam therapy equipment used for radiotherapy: Design features previously considered essential for the safe operation of this ME equipment: This is the setting for reducing the performance of ME equipment When the limit is reached, the ME equipment is considered to be in a fault state: For example, when a component fails, the interlock action needs to be triggered correspondingly to Prevent the continued operation of ME equipment: As we all know, before installing ME equipment, the manufacturer should be able to provide proof of compliance only related to the type test: Install on ME equipment After installation, the tester of the ME equipment shall pass the on-site inspection to provide data in the form of on-site inspection report and include it in the random file: See:201:1:3 and:201:1:4 for the relationship between this part and GB 9706:1 (including revised documents) and parallel standards: Medical electrical equipment Part 2-11: Gamma beam therapy equipment Special requirements for basic safety and basic performance 201:1 Scope, purpose and related standards Except for the following, general standard 1) Chapter 1 applies: 1) General standard refers to GB 9706:1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance": 201:1:1 Scope replace: This part is used for the basic safety and basic performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment, hereinafter referred to as ME equipment: If a chapter or article clearly states that it is only applicable to ME equipment or ME systems, the title and content of the chapter or article will be explained: If not If this is the case, the chapter or article applies to ME equipment and ME systems: In addition to 7:2:13 and 8:4:1 of the general standard, the expected physiological effects of the ME equipment or ME system within the scope of this part are caused by There are no specific requirements for hazards in this section: Note: See General Standard 4:2: 201:1:2 Purpose replace: The purpose of this section is to establish specific requirements for the basic safety and basic performance of gamma beam therapy equipment: 201:1:3 Parallel standards Supplement: This section refers to the applicable collateral standards listed in Chapter 2 of the General Standards and:201:2 of this section: IEC 60601-1-3 and IEC 60601-1-10 are not applicable: All other parallel standards of the IEC 60601-1 series are applicable after publication: 201:1:4 Specific standards replace: In the IEC 60601 series, for the special ME equipment considered, special standards may modify, replace or delete general standards and parallels: The requirements contained in the listed standards may also increase other basic safety and basic performance requirements: The requirements of specific standards take precedence over 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 general standard The content of Chapter 1), or by adding the prefix "20×" to correspond to the applicable parallel standard, where × is the number of the international standard corresponding to the parallel standard The last digit (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 Column standard IEC 60601-1-3 in Chapter 4, etc:): Changes to the text of the general standard require the use of the following words: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.211-2020_English be delivered?Answer: Upon your order, we will start to translate GB 9706.211-2020_English as soon as possible, and keep you informed of the progress. 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