GB 9706.239-2021 English PDFUS$419.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.239-2021: Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment Status: Valid
Basic dataStandard ID: GB 9706.239-2021 (GB9706.239-2021)Description (Translated English): Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment Sector / Industry: National Standard Classification of Chinese Standard: C45 Word Count Estimation: 21,240 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.239-2021: Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis 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 2-39.Particular requirements for basic safety and essential performance of peritoneal dialysis equipment ICS 11.040.20 C45 National Standards of People's Republic of China Replace GB 9706.39-2008 Medical Electrical Equipment Part 2-39.Peritoneal Dialysis Special requirements for basic safety and basic performance of equipment (IEC 60601-2-39.2018, MOD) Released on 2021-08-10 2023-05-01 implementation State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee Table of contentsForeword Ⅰ Introduction Ⅲ 201.1 Scope, objectives 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 testing of ME equipment 6 201.6 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 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) 8 201.11 Protection against over-temperature and other hazards (sources) 8 201.12 Accuracy of controllers and instruments and protection against dangerous outputs 9 201.13 Dangerous conditions and fault states of ME equipment 10 201.14 Programmable Medical Electrical System (PEMS) 10 201.15 Structure of ME equipment 10 201.16 ME System 11 201.17 Electromagnetic compatibility of ME equipment and ME systems 11 202 Electromagnetic compatibility---requirements and tests 11 208 *General requirements, testing and guidelines for alarm systems in ME equipment and ME systems 11 209 Environmental Awareness Design Requirements 12 211 Requirements for ME equipment and ME systems used in home care environments 12 Appendix 13 Appendix G (Normative Appendix) Protection against the danger (source) of igniting flammable anesthetic mixtures 14 Appendix AA (informative appendix) Special guidance and explanation 15 Reference 16ForewordGB 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 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.Specific requirements for the 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 part is part 2-39 of GB 9706. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB 9706.39-2008 "Medical Electrical Equipment Part 2-39.Special Requirements for the Safety of Peritoneal Dialysis Equipment", and Compared with GB 9706.39-2008, the main technical changes are as follows. ---Added the requirements of basic performance (see.201.4. ---Added the requirements of the programmable medical electrical system (PEMS) (see.201.14); ---Added the requirements of the ME system (see.201.16); ---Added requirements for testing and guidelines for medical electrical equipment and alarm systems in medical electrical systems (see Chapter 208); ---Added environmental awareness design requirements (see Chapter 209); ---Added requirements for medical electrical equipment and medical electrical systems used in home care environments (see Chapter 211); ---Added the requirements for the interruption of the power supply/power supply network of ME equipment (see.201.11.8); ---Added the requirements for dialysate components (see.201.12.4.4.105). This part uses the redrafting law to amend and adopt IEC 60601-2-39.2018, Medical Electrical Equipment Part 2-39.Peritoneal Dialysis Equipment Specific requirements for basic safety and basic performance of equipment. The technical differences between this part and IEC 60601-2-39.2018 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 ISO 3744 with GB/T 3767 which is equivalent to adopting international standards; ● Replace IEC 61672-1 with GB/T 3785.1 which is equivalent to adopting international standards; ● Replace IEC 60601-1-2.2014 with YY9706.102-2021 which is modified to adopt international standards; ● Replace IEC 60601-1-3 with GB 9706.103, which is modified to adopt international standards; ● Replace IEC 60601-1-6.2010 AMD1.2013 with YY/T 9706.106-2021 which is modified to adopt international standards; ● Replace IEC 60601-1-8.2006 AMD1.2012 with YY9706.108-2021 which is modified to adopt international standards; ● Replace IEC 60601-1-11.2015 with YY9706.111-2021 which is modified to adopt international standards; ● Replace IEC 60601-1-12 with YY9706.112 which is modified to adopt international standards. --- Regarding electromagnetic compatibility requirements and tests, the applicable parallel standard is changed to YY9706.102-2021 (see Chapter 202); ---According to MT20's information work documents and product expected use environmental risks, 208.6.3.2.2.1 and 208.6.3.3.1 were modified (See 208.6.3.2.2.1 and 208.6.3.3.1). This section has made the following editorial changes. ---Deleted some informative notes; ---The term index at the end of the international standard text 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 these patents. This part is proposed and managed by the State Drug Administration. The previous releases of the standards replaced by this part are as follows. ---GB 9706.39-2008.IntroductionThe minimum safety requirements specified in this section are considered to provide safety feasibility in the operation of peritoneal dialysis equipment. Medical Electrical Equipment Part 2-39.Peritoneal Dialysis Special requirements for basic safety and basic performance of 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 part of GB 9706 is applicable to the basic safety and basic performance of peritoneal dialysis ME equipment defined in.201.3.208 (hereinafter referred to as PD equipment). This section applies to PD devices that are expected to be used by medical staff or under the supervision of medical experts, including use in hospitals Or a PD device operated by a patient used in a home environment. If a chapter or a clause clearly states that it is only applicable to ME equipment or ME systems, the title or body of the chapter or clause will say bright. If this is not the case, the relevant chapters or articles apply to ME equipment or ME systems at the same time. Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the expected physiological effects of the ME equipment or ME system within the scope of this part are There are no specific requirements in this section. Note. See 4.2 of the general standard. This section also applies to PD devices used to eliminate or reduce disease, injury or disability. This section does not apply to dialysate or dialysate lines. 201.1.2 Purpose replace. The purpose of this section is to establish dedicated basic security and basic performance requirements for PD devices defined in.201.3.208. 201.1.3 Parallel standards Supplement. This section refers to Chapter 2 of the General Standards and applicable parallel standards listed in.201.2 of this section. YY9706.102-2021, YY9706.108-2021 and YY9706.111-2021 are in Chapter 202, Chapter 208 and Chapter 211 applies after modification. GB 9706.103 and YY9706.112 are not applicable. As mentioned in Chapter 209, IEC 60601-1-9.2007 AMD1.2013 does not apply. 201.1.4 Specific standards replace. In the GB 9706 series, the special standards can be modified, replaced or deleted according to the special ME equipment under consideration, the 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 section, GB 9706.1-2020 is referred to as the general standard. Parallel standards are represented by their respective standard numbers. The number of chapters and articles in this part is prefixed with "201" to correspond to the general standard (for example,.201.1 in this part corresponds to the general standard Chapter 1), or add the prefix "20×" to correspond to the applicable parallel standard, where "×" is the last digit of the international standard number corresponding to the parallel standard (For example, 202.4 in this part corresponds to the content of Chapter 4 in the collateral standard YY9706.102, and 203.4 in this part corresponds to the collateral standard ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.239-2021_English be delivered?Answer: Upon your order, we will start to translate GB 9706.239-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. 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