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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.222-2022: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Status: Valid
Basic dataStandard ID: GB 9706.222-2022 (GB9706.222-2022)Description (Translated English): Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Sector / Industry: National Standard Classification of Chinese Standard: C43 Word Count Estimation: 27,230 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.222-2022: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser 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 2-22.Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ICS 11.040.60 CCSC43 National Standards of People's Republic of China Replacing GB 9706.20-2000 Medical Electrical Equipment Part 2-22.Surgical, Orthopaedic, Basic safety and Specific requirements for basic performance equipment (IEC 60601-2-22.2019,MOD) 2022-03-15 Released 2024-05-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface I Introduction IV 201.1 Scope, Purpose and Related Criteria1 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 SYSTEM 5 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENT 5 201.8 ME EQUIPMENT PROTECTION TO ELECTRIC SHOCK HAZARD (SOURCE) 7 201.9 Protection of me equipment and me systems against mechanical hazards 8 201.10 Protection against unwanted or excessive radiation hazards (sources) 9 201.11 Protection against ultra-temperature and other hazards (sources) 11 201.12 Accuracy of control devices and instruments and protection of hazardous outputs 11 201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAILURE STATES 13 201.14 Programmable Medical Electrical System (PEMS) 14 201.15 Structure of ME equipment 14 201.16 ME System 14 201.17 Electromagnetic compatibility of ME equipment and ME systems 14 Appendix 15 Appendix D (informative) Symbols for marking 16 Appendix AA (Informative) Specific Guidelines and Rationale 18 Reference 20 forewordThis 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" drafted. This document is part 2-22 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 Essential Performance Collateral Standard. Radiation Protection of Diagnostic X-ray Equipment; --- Part 2-1.Specific requirements for basic safety and basic performance of electron accelerators with energies from 1MeV to 50MeV; --- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories; --- Part 2-3.Specific requirements for basic safety and basic performance of shortwave therapy equipment; --- Part 2-5.Specific requirements for the basic safety and basic performance of ultrasonic physiotherapy equipment; --- Part 2-6.Specific requirements for basic safety and basic performance of microwave therapy equipment; --- Part 2-8.Particular requirements for basic safety and basic performance of therapeutic X-ray equipment with energy from 10kV to 1MV; --- Part 2-11.Particular requirements for basic safety and basic performance of gamma beam therapy equipment; --- Part 2-12.Specific requirements for basic safety and basic performance of critical care ventilators; --- Part 2-13.Particular requirements for basic safety and basic performance of anesthesia workstations; --- Part 2-16.Particular requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment; --- Part 2-17.Special requirements for the basic safety and basic performance of automatically controlled brachytherapy afterloading equipment; --- Part 2-18.Particular requirements for basic safety and basic performance of endoscopic equipment; --- Part 2-19.Specific requirements for the basic safety and basic performance of infant incubators; --- Part 2-22.Particular requirements for the basic safety and basic performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic use; --- Part 2-24.Particular requirements for basic safety and basic performance of infusion pumps and infusion controllers; --- Part 2-25.Particular requirements for basic safety and basic performance of electrocardiographs; --- Part 2-26.Specific requirements for basic safety and basic performance of EEG machines; --- Part 2-27.Particular requirements for basic safety and basic performance of ECG monitoring equipment; --- Part 2-28.Particular requirements for basic safety and basic performance of medical diagnostic X-ray tube assemblies; --- Part 2-29.Specific requirements for basic safety and basic performance of radiotherapy simulators; --- Part 2-36.Particular requirements for the basic safety and basic performance of in vitro induced lithotripsy equipment; --- Part 2-37.Particular requirements for basic safety and basic performance of ultrasonic diagnostic and monitoring equipment; --- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment; --- Part 2-43.Particular requirements for basic safety and basic performance of interventional X-ray equipment; --- Part 2-44.Particular requirements for the basic safety and basic performance of X-ray computed tomography equipment; --- Part 2-45.Special use for basic safety and basic performance of mammography equipment and mammography stereotaxic devices Require; --- Part 2-54.Particular requirements for basic safety and basic performance of X-ray photography and fluoroscopy equipment; --- Part 2-60.Particular requirements for basic safety and basic performance of dental equipment; --- Part 2-63.Special requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging; --- Part 2-65.Special requirements for basic safety and basic performance of intraoral imaging dental X-ray machines. This document replaces GB 9706.20-2000 "Medical electrical equipment - Part 2.Special requirements for the safety of diagnostic and therapeutic laser equipment Compared with GB 9706.20-2000, in addition to structural adjustment and editorial changes, the main technical changes are as follows. --- The general part refers to GB 9706.1-2020; --- Modified the scope and purpose (see Chapter 1 of.201.1,.2000 edition); --- Added normative references (see.201.2); --- Delete the terms "aiming spot", "(medical) laser equipment", "shutter" and "working laser" (see 2.1.103 of the.2000 edition, 2.1.111, 2.1.116 and 2.1.121); ---Added "Class 1C", "Enclosed Laser", "Good Contact", "Laser Emission Control Switch", "Laser Operator", "Maximum Allowable Irradiation" terms and definitions of "quantity" and "stray light radiation" (see.201.3.206,.201.3.212,.201.3.213,.201.3.214,.201.3.217, 201.3.220 and.201.3.224); --- Merge the term "laser output" into the terms "laser energy" and "laser power". (See.201.3.216 and.201.3.218,.2000 versions 2.1.110, 2.1.112 and 2.1.113); --- Modified the terms "operator protection filter", "target indicating device", "working beam" (see.201.3.221,.201.3.225 and 201.3.227, 2.1.115, 2.1.118 and 2.1.120 of the.2000 edition); --- Modified the term "preparation" and the part of the standard involving "preparation" [see.201.3.219,.201.3.222,.201.10.4.101d), Chapter 32 d), Chapter 32 e), 56.101, 104 of Table D1, 105 of Table D1]; --- Revised the requirements for ME equipment identification, marking and documentation (see Chapter 6 of.201.7,.2000 edition); --- Added "It is necessary to give information that the measuring equipment has been periodically calibrated to meet the requirements of the corresponding technical regulations." [See.201.7.9.2.101f)]; --- Added requirements for "parts isolation" (see.201.8.5); --- Deleted "If the laser equipment has an emergency terminator that meets the requirements of IEC 60947-3, it is not required to have an emergency laser termination. stopper" (see 51.101 of the.2000 edition); ---Added the requirement of "Laser", and integrated the original standard "Light Radiation", "Enclosure and Cover" and "Standby/Ready" modification and integration into this clause. At the same time, "restrictions on laser output", "interlocking system for Class 1C laser equipment", "optical "Laser radiation filters in observers" requirements. (see.201.10.4, Chapters 32, 55 and 56.101 of the.2000 edition); --- Added requirements for "spectral impurity" (see.201.12.4.4.102); --- Deleted the requirement of "creepage distances and clearances" (57.10 of the.2000 edition); --- Revised "ME EQUIPMENT HAZARDOUS CONDITIONS AND FAILURE STATES", replacing the original standard "abnormal operation and fault status" and "timer" parts. Sub-modifications were incorporated into this clause, adding the requirements for "excessive laser output" and "irradiation termination failure after loss of good contact" (see Chapter 52 and 56.102 of.201.13,.2000 edition). This document uses the redrafting method to modify and adopt IEC 60601-2-22.2019 "Medical Electrical Equipment Part 2-22.Surgery, Plastic Surgery, Particular requirements for the basic safety and essential performance of laser equipment for therapeutic and diagnostic use. The technical differences between this document and IEC 60601-2-22.2019 and their reasons are as follows. --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment. The situation is reflected in the "normative reference documents", and the specific adjustments are as follows. ● Replacing IEC 60601-1.2012 with GB 9706.1-2020 which has been modified to adopt international standards; ● Replace IEC 60825-1.2014 with GB 7247.1-2012 which is equivalent to adopting international standards. ---Because there is no requirement for emergency terminators in IEC 60947-3, and this clause has been deleted in the discussion draft of the new edition of IEC 60601-2-57, so Deleted.201.12.4.4.101 "If the laser equipment has an emergency terminator that meets the requirements of IEC 60947-3, do not Requires emergency laser terminators. " --- Since.201.12.4.4.101 deleted the relevant clauses of IEC 60947-3, the referenced IEC 60947-3 was deleted. ---Because IEC /T R60878.2003 has been obsolete, the current effective one is IEC /T R60878.2015, so delete the footnote a of Table D.1 The year number in IEC /T R60878. --- Added.201.7.9.2.101f) "To give the information that the measuring equipment has been calibrated regularly to meet the requirements of the corresponding technical regulations." The following editorial changes have been made to this document. --- Deleted "Shaping" in Note 3 of.201.7.9.2.101; --- Deleted the term index of the International Standard. Please note that certain content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the State Drug Administration. The previous versions of this document and its superseded documents are as follows. ---First released in.2000 as GB 9706.20-2000; ---This is the first revision.IntroductionMedical electrical equipment safety standards, also known as the 9706 series of standards, consist of general standards, side-by-side standards, specific standards, guidelines and interpretations. ---General standard. 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. --- Side-by-side standard. Medical electrical equipment should be generally applicable to the safety standards, but in most cases only limited to some specific functions or special Only devices that are sexual are required to meet the requirements of such standards. ---Special standard. a safety standard applicable to a certain type of medical electrical equipment, and not all medical electrical equipment has special standard. ---Guidelines and interpretations. interpretations of the application guidelines and clauses of the relevant requirements in the standards involved. In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows. --- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators. The aim is to establish the basics of a cardiac defibrillator Specific requirements for safety and essential performance. --- Part 2-66.Specific requirements for the basic safety and basic performance of hearing devices and hearing device systems. The purpose is to establish a listening Particular requirements for basic safety and basic performance of force equipment and hearing equipment systems. This document addresses basic safety and essential performance requirements for surgical, orthopedic, therapeutic and diagnostic laser equipment. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance". In this document, an asterisk (*) is used as the first character of a title or the beginning of a paragraph or table title, indicating that there is a reference to this item in Appendix AA. Specific guidelines and principles related to the project are provided. The relevant content of Appendix AA will not only help to use this document correctly, but also add it in a timely manner. Rapid process of revision of standards due to changes in clinical practice or technological developments. Medical Electrical Equipment Part 2-22.Surgical, Orthopaedic, Basic safety and Specific requirements for basic performance 201.1 Scope, Purpose and Related Standards Except as described below, Chapter 1 of the General Standard applies. 201.1.1 Scope replace. This document specifies the basic safety and essential performance of laser equipment for use in surgery, therapy, diagnosis, and shaping, which are classified as containing Class 1C, 3B or 4 laser products with Class 3B or Class 4 enclosed lasers. In this document, medical electrical equipment or medical electrical systems that transmit laser light as an energy source to a patient are referred to as "laser equipment". Note 1.Laser products classified as Class 1, Class 1M, Class 2, Class 2M or Class 3R in these applications are applicable to GB 7247.1-2012 and the general standard. If a chapter or article applies only to ME EQUIPMENT or ME SYSTEMS, the title and content of that chapter or article will clearly state this. if Without expressly stated, this chapter or subclause applies to related ME EQUIPMENT and ME SYSTEM. With the exception of general standard 7.2.13 Physiological effects, specific requirements within the scope of this document do not cover inherent hazards to the intended physiological function of laser devices risk (source). Note 2 to entry. See General Standard 4.2 Risk Management Process for ME EQUIPMENT or ME SYSTEMS. Note 3.If the laser equipment is classified into class 1C and used for domestic use, the laser equipment complies with IEC 60335-2-113.2016. 201.1.2 Purpose replace. The purpose of this document is to specify safety-specific requirements for the basic safety and essential performance of surgical, orthopedic, therapeutic and diagnostic laser equipment. 201.1.3 Tied standards Added. This document refers to Chapter 2 of the General Standard and the applicable collateral standards listed in.201.2 of this document. 201.1.4 Particular standards Added. In the GB 9706 series, the special standard may modify, replace or delete the general standard and the parallel standard according to the special ME EQUIPMENT under consideration. requirements contained in the standard. Other basic safety and basic performance requirements may be supplemented. The requirements of the specific standard take precedence over the requirements of the general standard. GB 9706.1-2020 is referred to as the general standard in this document. Collateral standards are indicated by their respective document numbers. The prefix "201" before the numbering of chapters and articles in this document corresponds to the general standard (for example,.201.1 in this document corresponds to the general standard Chapter 1), or add the prefix "20×" to correspond to the applicable collateral standard, where "×" is the last digit of the corresponding international standard number for the collateral standard Numbers (for example, 202.4 in this document corresponds to the content of Chapter 4 of the collateral standard YY9706.102, and 203.4 in this document corresponds to the collateral standard Contents of Chapter 4 in GB 9706.103, etc.). Changes to the Common Criteria text are governed by the use of the following words. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.222-2022_English be delivered?Answer: Upon your order, we will start to translate GB 9706.222-2022_English as soon as possible, and keep you informed of the progress. 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