GB 9706.260-2020 English PDFUS$499.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.260-2020: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment Status: Valid
Basic dataStandard ID: GB 9706.260-2020 (GB9706.260-2020)Description (Translated English): Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment Sector / Industry: National Standard Classification of Chinese Standard: C33 Classification of International Standard: 11.040.01 Word Count Estimation: 27,277 Date of Issue: 2020-11-17 Date of Implementation: 2023-05-01 Quoted Standard: GB 7247.1; GB/T 16935.1-2008; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; GB/T 16935.4-2011; ISO 14457-2017; IEC 60601-2-22-2007; IEC 60601-2-57-2011; IEC 61180-2016; IEC 61810-1-2008; IEC 62471 Adopted Standard: IEC 80601-2-60-2012, MOD Regulation (derived from): National Standard Announcement No. 25 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 requirements of dental units, dental patient chairs, dental hand-held equipment, and dental lamps (hereinafter collectively referred to as dental equipment). Does not include amalgam blenders, sterilization equipment and dental X-ray equipment. If a clause or sub-clause clearly applies only to medical electrical equipment or only to medical electrical systems, it will be explained in its title and content. If no explanation is given, this clause or sub-clause applies to both the relevant medical electrical equipment and medical electrical system. Except for the content specified in 7.2.13 and 8.4.1 of the general standard, the inherent hazards of the characteristics and functions of relevant medical electrical equipment or medical electrical systems within the scope of this standard are not described in the specific requirements of this standard. GB 9706.260-2020: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental 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 2-60.Particular requirements for the basic safety and essential performance of dental equipment ICS 11.040.01 C33 National Standards of People's Republic of China Medical Electrical Equipment Part 2-60. Specific requirements for basic safety and basic performance of dental equipment 2020-11-17 released 2023-05-01 implementation State Administration for Market Regulation 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 3 201.6 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 4 201.9 Protection of ME equipment and ME systems against mechanical hazards 8 201.10 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 12 201.13 Dangerous conditions and fault states of ME equipment 12 201.14 Programmable Medical Electrical System (PEMS) 13 201.15 Structure of ME equipment 13 201.16 ME System 13 201.17 Electromagnetic compatibility of ME equipment and ME systems 13 201.101 Wireless handheld and foot-operated controls 13 Appendix 14 Appendix AA (informative appendix) Guidance and rationale for special clauses 15 Reference 23ForewordGB 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 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 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 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.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.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.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.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.Special requirements for the basic safety and basic performance of mammography equipment and mammography stereotaxic devices; ---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 2-60 of GB 9706. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the redrafting law to modify and adopt IEC 80601-2-60.2012 "Medical Electrical Equipment Part 2-60.Dental Equipment Special requirements for basic safety and basic performance. The technical differences between this part and IEC 80601-2-60.2012 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 60825-1 with GB 7247.1 which is equivalent to adopting international standards; ● Replace ISO 1942 (all parts) with GB/T 9937 (all parts). The degree of consistency between the parts of the two standards is as follows. ● GB/T 9937.1-2008 oral vocabulary part 1.basic and clinical terms (ISO 1942-1.1989, IDT); ● GB/T 9937.2-2008 Dental Vocabulary Part 2.Dental Materials (ISO 1942-2.1989, IDT); ● GB/T 9937.3-2008 Dental Vocabulary Part 3.Dental Devices (ISO 1942-3.1989, IDT); ● GB/T 9937.4-2005 Dental Terminology Part 4.Dental Equipment (ISO 1942-4.1989, IDT); ● GB/T 9937.5-2008 Oral Vocabulary Part 5.Terms related to testing (ISO 1942-5.1989, IDT). ---The IEC 61180-1 and IEC 61180-2 cited in the original text have been replaced by IEC 61180.2016, so they are in.201.2 and.201.8. In 9.1.12, IEC 61180.2016 is used to replace IEC 61180-1 and IEC 61180-2. ---ISO 7785-2 and ISO 11498 cited in the original text have been replaced by ISO 14457.2017, so they are in.201.2,.201.11.1.3. Use ISO 14457.2017 instead of ISO 7785-2 and ISO 11498. ---Modify the translations of.201.1.3 and.201.1.4 to be consistent with domestic standards. This section also made the following editorial changes. --- The appendix under "Summary and Basic Principles of Insulation" in Appendix AA is deleted, which is consistent with GB/T 16935.1-2008 The table F.1 is consistent and will not be repeated; --- Deleted the "term index". 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. Medical Electrical Equipment Part 2-60. Specific requirements for basic safety and basic performance of dental equipment 201.1 Scope, purpose and related standards Except for the following, Chapter 1 of the general standard applies. 201.1.1 Scope of application replace. This section applies to the basic safety of dental units, dental patient chairs, dental handheld devices, and dental lamps (hereinafter collectively referred to as dental equipment) And basic performance requirements. Does not include amalgam blenders, sterilization equipment and dental X-ray equipment. If the clause or sub-clause clearly applies only to medical electrical equipment or only to medical electrical systems, then in its title and content Will be explained. If no explanation is given, the clause or sub-clause applies to both the relevant medical electrical equipment and medical electrical system. In addition to the content specified in 7.2.13 and 8.4.1 of the general standards, relevant medical electrical equipment or medical electrical equipment within the scope of this part The inherent hazards of the system features are not described in the specific requirements in this section. Note. Refer to 4.2 in the general standard. 201.1.2 Purpose replace. The purpose of this special standard is to determine the basic safety and basic performance requirements of dental equipment (as defined in.201.3.202). 201.1.3 Parallel standards Supplement. This special standard refers to Chapter 2 of the general standard and applicable parallel standards listed in.201.2 of this special standard. 201.1.4 Specific standards replace. Special standards can modify, replace or delete requirements contained in general standards or parallel standards to apply to the ME equipment under consideration, or Increase other basic safety and basic performance requirements. The requirements of specific standards take precedence over the requirements of general standards. For the sake of brevity, GB 9706.1 in this special standard is called the general standard, and parallel standards are represented by their standard numbers. The numbering of the chapters and articles in this special standard corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this special standard corresponds to Use the content of Chapter 1 of the standard), or by adding the prefix "20×" to correspond to the applicable parallel standard, where × is the parallel standard corresponding to the international standard The last digit of the standard number (for example, 202.4 in this special standard corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-2, this special standard Standard 203.4 corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-3, etc.). For changes to the general standard text, the following Words. "Replacement" means that the chapters and articles of the general standard or applicable parallel standards are completely replaced by the articles of this specific standard. "Supplement" refers to the provisions of this special standard that supplement the requirements of general standards or applicable parallel standards. "Modification" refers to the modification of the chapters and articles of general standards or applicable parallel standards in accordance with the description of the provisions of this special standard. As a supplement to the general standard, the numbering of bars, figures and tables starts from.201.101.However, since the number defined in the general standard changes from ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.260-2020_English be delivered?Answer: Upon your order, we will start to translate GB 9706.260-2020_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 9706.260-2020_English with my colleagues?Answer: Yes. The purchased PDF of GB 9706.260-2020_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. |
