GB 9706.226-2021 English PDFUS$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.226-2021: Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Status: Valid
Basic dataStandard ID: GB 9706.226-2021 (GB9706.226-2021)Description (Translated English): Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Sector / Industry: National Standard Classification of Chinese Standard: C39 Word Count Estimation: 28,215 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.226-2021: Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs---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 2-26.Particular requirements for the basic safety and essential performance of electroencephalographs ICS 11.040.55 CCSC39 National Standards of People's Republic of China Replace GB 9706.26-2005 Medical electrical equipment-Part 2-26.EEG machine Special requirements for basic safety and basic performance (IEC 60601-2-26.2012,MOD) Released on 2021-10-11 2023-05-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsForeword Ⅲ Introduction Ⅴ 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 systems against mechanical hazards 9 201.10 Protection against unwanted or excessive radiation risks 9 201.11 Protection against over-temperature and other hazards 10 201.12 Accuracy of controllers and instruments and protection against dangerous outputs 10 201.13 Dangerous situations and fault states 14 201.14 Programmable Medical Electrical System (PEMS) 14 201.15 Structure of ME equipment 15 201.16 ME System 15 201.17 Electromagnetic compatibility of ME equipment and ME systems 15 202 Electromagnetic compatibility---requirements and tests 15 202.6 Electromagnetic compatibility 15 Appendix 19 Appendix AA (informative) Special guide and principle description 20 Reference 22 Figure.201.101 Defibrillation protection test (common mode mode) 7 Figure.201.102 Defibrillation protection test (differential mode) 8 Figure.201.103 Apply a test voltage between the lead wires to test the energy released by the defibrillator 9 Figure.201.104 General test circuit Figure 12 Figure.201.105 Common mode rejection test circuit diagram (see.201.12.1.101.5) 14 Figure 202.101 Radiated emission and conducted emission test layout [see 202.6.1.1.2a)] 16 Figure 202.102 According to the radiated immunity test setting of 202.6.2.3.2 17 Table.201.101 Basic performance requirements for dispersion 4ForewordThis 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 2-26 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.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 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.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.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 document replaces GB 9706.26-2005 "Medical Electrical Equipment Part 2-26.Special Requirements for the Safety of EEG Machines". This document and Compared with GB 9706.26-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the scope of application and deleted the brain function monitor (see.201.1.1,.2005 edition 1.1); --- Increased performance requirements (see.201.12.1), and stipulated the basic performance (see.201.4.3.). This document uses the redrafting method to modify and adopt IEC 60601-2-26.2012 "Medical Electrical Equipment Part 2-26.EEG Machine Special requirements for basic safety and basic performance. The technical differences between this document and IEC 60601-2-26.2012 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; ● Added GB/T 4208-2017; ● Removed IEC 60601-2-27.2011 and adjusted to references. The following editorial changes have been made to this document. ---The term index of the international standard 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 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.2005 as GB 9706.26-2005; ---This is the first revision.IntroductionThe safety standards for medical electrical equipment are also known as the 9706 series of standards, which are to be composed of general standards, parallel standards, special standards, guidelines and interpretations constitute. ---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 the basic safety and basic performance of cardiac defibrillators; ---Part 2-22.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. This document deals with the basic safety and basic performance specific requirements of EEG machines. This document revised and supplemented GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance." The requirements of this document have a higher priority than general standards. 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 2-26.EEG machine 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 replace. This document specifies the basic safety and basic performance of EEG machines (hereinafter referred to as ME equipment) defined in.201.3.63. This document applies to ME equipment used in clinical environments (for example, hospitals, doctors' offices, etc.). This document does not apply to other equipment used in EEG, such as. ---Acousto-optic stimulator; --- Telemetry EEG; --- EEG data storage and reproduction equipment; ---Special ME equipment for monitoring in electroconvulsive therapy; ---A dynamic EEG recorder. If a chapter or article clearly states that it is only applicable to ME equipment or ME systems, the title and the text of the chapter or article will explain. if not In this case, the relevant chapters or articles apply to both ME equipment and ME systems. In addition to 7.2.13 and 8.4.1 of the general standard, the expected physiological effects of ME equipment or ME systems within the scope of this document are caused by There are no specific requirements for hazards in this document. Note. See 4.2 of the General Standard. 201.1.2 Purpose replace. The purpose of this document is to establish the specific basic safety and basic performance requirements of EEG machines as defined in.201.3.63. 201.1.3 Parallel standards 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. 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 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 the first chapter of the general standard). Chapter), or add the prefix "20x" to correspond to the applicable collateral standard, where x is the last digit of the international standard number corresponding to the collateral standard (e.g. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.226-2021_English be delivered?Answer: Upon your order, we will start to translate GB 9706.226-2021_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 9706.226-2021_English with my colleagues?Answer: Yes. The purchased PDF of GB 9706.226-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
