GB 9706.236-2021 English PDFUS$339.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.236-2021: Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Status: Valid
Basic dataStandard ID: GB 9706.236-2021 (GB9706.236-2021)Description (Translated English): Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy Sector / Industry: National Standard Classification of Chinese Standard: C39 Word Count Estimation: 18,127 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.236-2021: Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy---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 2-36.Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy ICS 11.040.01 CCSC39 National Standards of People's Republic of China Replace GB 9706.22-2003 Medical Electrical Equipment Part 2-36.In Vitro Initiation Specific requirements for basic safety and basic performance of stone crushing equipment (IEC 60601-2-36.2014, MOD) Released on 2021-12-01 2023-05-01 implementation 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 3 201.5 General requirements for ME equipment testing 4 201.6 Classification of ME equipment and ME systems 4 201.7 ME equipment identification, marking and documentation 4 201.8 Protection of ME equipment against electric shock hazard 5 201.9 Protection of ME equipment and ME system against mechanical hazards 5 201.10 Protection against unwanted or excessive radiation hazards (sources) 6 201.11 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 7 201.17 Electromagnetic compatibility of ME equipment and ME systems 7 202 *Electromagnetic Compatibility---Requirements and Tests 8 Appendix 9 Appendix AA (informative) Special guide and principle explanation 10 Appendix BB (informative) Coordinate definition, focus and target position 11 Reference 12ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is part 2-36 of GB 9706 "Medical Electrical Equipment". GB 9706 has released 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 2-5.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 2-24.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 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.Specific requirements for the basic safety and basic performance of dental X-ray machines for intraoral imaging. This document replaces GB 9706.22-2003 "Medical Electrical Equipment Part 2.Special Requirements for the Safety of In Vitro Induced Lithotripsy Equipment", and Compared with GB 9706.22-2003, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Added the term "energy flow density", "single pulse energy", "stone crushing equipment" (see.201.3.201,.201.32,.201.3.206); ---Added basic performance requirements (see.201.4.3.11); ---Added the minimum, typical and maximum output energy settings of the energy flow density, including the technical parameters of the time integration limit [see 201.7.9.3.101d)]. This document uses the redrafting method to modify and adopt IEC 60601-2-36.2014 "Medical Electrical Equipment Part 2-36.In Vitro Induced Fragmentation Special requirements for basic safety and basic performance of stone equipment. The technical differences between this document and IEC 60601-2-36.2014 and the reasons are as follows. ---Regarding normative reference documents, this document 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", and the specific adjustments are as follows. ● Replace IEC 60601-1.2005 with GB 9706.1-2020, which is modified to adopt international standards; ● Replace IEC 60601-1-2.2007 with YY9706.102-2021 which is modified to adopt international standards; ● The IEC 60601-2-5.2009, which is not normatively cited in the text, is transferred to the reference. The following editorial changes have been made to this document. ---The term index is 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 patents. This document was proposed and managed by the State Drug Administration. The previous releases of this document and the documents it replaced are as follows. ---First released in.2003 as GB 9706.22-2003;IntroductionMedical electrical equipment safety standards are also known as the 9706 series of standards, which consist of general standards, parallel standards, special standards, guidelines and interpretations. ---General standards. Medical electrical equipment should be generally applicable to safety standards, that is, equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. ---Parallel standards. Medical electrical equipment should be generally applicable to safety standards, but in most cases it is limited to certain specific functions or features. Sexual equipment only needs to meet the requirements of such standards. ---Special standards. safety standards that a certain type of medical electrical equipment should apply, and not all medical electrical equipment have special standard. ---Guidelines and explanations. application guidelines and explanations for the relevant requirements in the standards involved. In the GB 9706 series of standards, in addition to the published standards and this document, the standards that have been included in the plan are as follows. ---Part 2-4.Special requirements for basic safety and basic performance of cardiac defibrillators. The purpose is to establish the basic Special requirements for safety and basic performance. ---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis. The purpose is Establish special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis. ---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system. The purpose is to build listening Specific requirements for basic safety and basic performance of equipment and hearing equipment systems. This document focuses on the basic safety and basic performance of in vitro lithotripsy equipment. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Safety and Basic Performance Require". In this document, the asterisk (*) is used as the first character of the title or the beginning of the paragraph or table title, which means that there is a related item in Appendix AA. Dedicated guides and principle explanations related to the project. The relevant content of Appendix AA is not only helpful for the correct use of this document, but also can be added in a timely manner. The process of revising standards due to changes in clinical practice or technological development. Medical Electrical Equipment Part 2-36.In Vitro Initiation Specific requirements for basic safety and basic performance of stone crushing 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 document specifies the basic safety and performance of in vitro lithotripsy equipment. This document is applicable to the in vitro induced lithotripsy equipment defined in.201.3.206, including other in vitro induced focused pressure pulses. Other medical application equipment, hereinafter referred to as ME equipment. The applicability of this document is limited to components directly related to lithotripsy. For example (not limited to Yu), pressure pulse generator, patient support equipment and their related imaging and monitoring equipment. Other equipment such as those used in patient treatment The program-controlled computer, X-ray and ultrasound equipment are not included in this document. This document does not apply to. ---Ultrasonic physical therapy equipment intended for physical therapy; ---Ultrasonic equipment (HITU) and other treatment equipment designed for high-intensity therapy as described in Appendix AA. 201.1.2 *Purpose replace. The purpose of this document is to establish the basic safety and basic performance requirements of in vitro lithotripsy equipment, including according to the definition of.201.3.206 Other medical application equipment for in vitro induced focused pressure pulse therapy. 201.1.3 Parallel standards Supplement. This document refers to Chapter 2 of the General Standard and applicable parallel standards listed in.201.2 of this document. YY9706.102-2021 is applicable after Chapter 202 is revised. GB 9706.103 and YY/T 9706.110 are not applicable. 201.1.4 Specific standards replace. In the GB 9706 series, special standards can be modified, replaced or deleted according to the professional ME equipment considered, general standards and parallel standards The requirements contained in the standards. Other basic safety and basic performance requirements can be added. The requirements of specific standards take precedence over the requirements of general standards. In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective document numbers. The numbering of chapters and articles in this document is prefixed with “201” to correspond to the general standard (for example,.201.1 in this document corresponds to Article Chapter 1), or add the prefix "20x" to correspond to the applicable collateral standard, where x is the last digit of the standard number corresponding to the collateral standard (for example, 202 in this document corresponds to the content in the parallel standard YY9706.102). Standardize changes to the text of the general standard by using the following words. "Replacement" means that the chapters and articles of the general standards or applicable parallel standards are completely replaced by the contents of this document. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.236-2021_English be delivered?Answer: Upon your order, we will start to translate GB 9706.236-2021_English as soon as possible, and keep you informed of the progress. 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