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Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.280-2023: Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency Status: Valid
Basic dataStandard ID: YY 9706.280-2023 (YY9706.280-2023)Description (Translated English): Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 72,756 Date of Issue: 2023-03-14 Date of Implementation: 2026-05-01 Older Standard (superseded by this standard): YY 0600.1-2007 Issuing agency(ies): State Drug Administration Summary: This standard specifies the basic safety and essential performance of respiratory support equipment used in combination with accessories for respiratory insufficiency. This document applies to respiratory support equipment intended to be operated by inexperienced operators in a home care setting for the intended transfer of patients with respiratory insufficiency or failure. This document also applies to accessories intended by the manufacturer to be connected to respiratory systems of insufficient respiratory support equipment, the characteristics of which may affect the basic safety and essential performance of the insufficient respiratory support equipment. This document does not apply to equipment intended for use in patients who are dependent on artificial ventilation for life support in real time. This document does not apply to the use of intensive care ventilators and their accessories, anesthesia ventilators and their accessories, emergency and transport ventilators and their accessories, and patients dependent on ventilators YY 9706.280-2023: Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency---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. ICS11:040:10 CCSC46 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0600:1-2007 Medical Electrical Equipment Part 2-80: For Breathing Basic safety and Basic performance-specific requirements (ISO 80601-2-80:2018, MOD) 2023-03-14 release 2026-05-01 implementation Released by the State Drug Administration table of contentsPreface III Introduction V 201:1 Scope, purpose and related criteria1 201:2 Normative references 2 201:3 Terms and Definitions 4 201:4 General requirements 5 201:5 General requirements for testing of ME EQUIPMENT 7 201:6 Classification of me equipment and me systems7 201:7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION8 201:8 Protection against electric shock hazards for ME EQUIPMENT 13 201:9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 13 201:10 Protection against unwanted or excessive radiation hazards (sources)14 201:11 Protection against extreme temperatures and other hazards (sources) 14 201:12* Controls and instruments for accuracy and protection against hazardous outputs 17 201:13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 25 201:14 Programmable electrical medical systems (PEMS) 25 201:15 Construction of ME EQUIPMENT 25 201:16 ME system 26 201:17 Electromagnetic compatibility of me equipment and me systems 26 201:101 Gas connections 26 201:102 Requirements for VBS and Annexes 28 201:103* Spontaneous breathing during energy loss 29 201:104* Training 29 201:105* Indication of duration of operation 29 201:106 Functional connection 29 201:107 Display Ring Diagram 30 201:108 Power cords 30 201:109 Respiratory support equipment information security 30 202 Electromagnetic Compatibility Requirements and Tests 31 206 Availability 31 208 General requirements, tests and guidelines for alarm systems in me equipment and me systems 32 211 Requirements for me equipment and me systems for use in the home care environment 33 Appendix C (informative) ME EQUIPMENT or ME SYSTEM MARKING AND IDENTIFICATION REQUIREMENTS GUIDE 34 Appendix D (Informative) Symbols 40 Appendix AA (Informative) Special Guidelines and Rationale 41 Appendix BB (Informative) Data Interface Requirements 53 Appendix CC (Informative) Basic Principles Index 59 Reference 62forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: "Medical Electrical Equipment" is divided into two parts: --- Part 1: General and parallel requirements; --- Part 2: Special requirements: This document is Part 2-80: YY 9706:280-2023 and YY 9706:279-2023 jointly replace YY 0600:1-2007: With YY 0600:1-2007 In comparison, the main technical differences are as follows: --- Divide the scope covered by YY 0600:1-2007 into two parts: one for patients with respiratory dysfunction (YY 9706:279- 2023), and one for patients with respiratory insufficiency (YY 9706:280-2023); --- Expand the scope to include respiratory support equipment and its accessories, where the characteristics of these accessories may affect the basic This safety or essential performance, not just respiratory support equipment itself; --- Increased the basic performance of identifying respiratory support equipment and its accessories; --- Added respiratory ventilation performance requirements and tests; --- Added requirements for mechanical strength test; ---Increased the ability requirement to be operable while moving; --- Added new symbols; --- Increased the requirements for respiratory support equipment as part of the medical electrical system; --- Added shell integrity test; --- Added cleaning and disinfection procedure test; --- Increased consideration of the contamination of the breathing gas delivered to the patient from the gas pathway: This document is modified to adopt ISO 80601-2-80:2018 "Medical Electrical Equipment Part 2-80: Respiratory Devices for Respiratory Insufficiency Particular Requirements for Basic Safety and Essential Performance of Supporting Equipment": The technical differences between this document and ISO 80601-2-80:2018 and their reasons are as follows: --- Replaced IEC 61672-1:2013 with the normatively quoted GB/T 3785:1 to adapt to the technical conditions of our country; --- Replaced ISO 4135:2001 with the normatively quoted GB/T 4999-2003 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1:2005 AMD1:2012 with the normatively quoted GB 9706:1-2020 to adapt to my country's Technical conditions; --- Replaced ISO 80601-2-12:2020 with the normatively quoted GB 9706:212 to adapt to the technical conditions of our country; --- Replaced ISO 8836:2014 with the normative reference YY/T 0339 to adapt to the technical conditions of our country; --- Replaced ISO 5367:2014 with the normative referenced YY/T 0461 to adapt to the technical conditions of our country; --- Replaced ISO 15223-1:2016 with the normative reference YY/T 0466:1-2016 to adapt to the technical conditions of our country; --- Replaced ISO 17510:2015 with the normative reference YY/T 0671-2021 to adapt to the technical conditions of our country; --- Replaced ISO 9360-2:2001 with the normative reference YY/T 0735:2 to adapt to the technical conditions of our country; --- Replaced ISO 23328-1:2003 with the normative referenced YY/T 0753:1 to adapt to the technical conditions of our country; --- Replaced ISO 23328-2:2002 with the normative reference YY/T 0753:2 to adapt to the technical conditions of our country; --- Replaced ISO 80369-1:2010 with the normative reference YY/T 0916:1 to adapt to the technical conditions of our country; --- Replaced IEC 62366-1 with the normative referenced YY/T 1474 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-2:2014 with the normative reference YY 9706:102-2021 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-6 with the normative referenced YY/T 9706:106 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-8 with the normative reference YY 9706:108 to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-11 with the normative reference YY 9706:111-2021 to adapt to the technical conditions of our country; --- Replaced ISO 80601-2-72:2015 with the normative reference YY 9706:272 to adapt to the technical conditions of our country; --- Replaced ISO 80601-2-74:2017 with the normative reference YY 9706:274-2022 to adapt to the technical conditions of our country: The following editorial changes have also been made to this document: --- Deleted the term index of the international standard; --- In the source part of:201:3:201, the reference without the date number is changed to the reference with the date code, and the specific clause will be referenced Amended from:201:3:210 to:201:3:205; ---Corrected the error of quoting GB/T 3767-2016 article number in:201:9:6:2:1:101, and included ISO 80601-2-80:2018b) 8:1 in h) and k) was changed to 8:6; 8:1 in h) and k) was changed to 8:2; the formulas and Parameter Description: --- Amended the article number and content of 202; ---Corrected the error of quoting the article number in 202:6:2:1:3*, and changed the article pointed to by the specific conditions and configuration from:201:9:6:2:1:101 for:201:12:1:101 or:201:12:1:102; --- Added the missing "201:7:9:2:9:101:1 Operating Instructions for Inexperienced Operators" in Appendix AA Fundamental"; ---Appendix D amended the symbol 5 on the graphics and description of PHT substances: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116):IntroductionThis document specifies specific requirements for respiratory support equipment intended to be used in a home care environment where the life support of the patient being cared for Not dependent on ventilator ventilation: Such respiratory support equipment is often used in places where the power source is unreliable: Such respiratory support equipment Usually administered by non-medical personnel (inexperienced operators) with varying degrees of training: Respiratory support equipment conforming to this document may also be used Other settings (i:e: healthcare facilities): The development of the respiratory equipment industry in the world tends to be classified more and more finely: According to the degree of patients' symptoms and application scenarios, different categories are distinguished: Home ventilators with the same function can serve different patients more accurately: Specifically, for chronic respiratory failure, such as moderate to mild COPD The patients themselves have a certain ability to move, and the treatment pressure is not great; other patients, such as patients with acute respiratory failure such as severe COPD, also have ALS patients with gradual freezing require relatively high pressure for treatment, and they need to be transferred to a professional hospital when they go outdoors to expand their range of activities or during an acute attack: All medical institutions need ventilators with stronger functions: Therefore, ISO 10651-6:2004 (YY 0600:1-2007, MOD), under revision The ordering time is divided into two standards: ISO 80601-2-79:2018 and ISO 80601-2-80:2018: For patients requiring stable ventilation, varying levels of respiratory support are required and, in some cases, need to change as the condition progresses: This document applies to patients whose respiratory function has deteriorated so severely that they are unable to carry out the activities pursued and interfere with their daily life, Significant abnormalities in suction measurements or gas exchange: This best distinction is when lung function measures are no worse than: FEV1/FVC (also known as Tiffeneau-Pineli index) < 70%; or FEV1< 50% predicted value Among them, FEV1 is the forced expiratory volume in one second, and FVC is the forced vital capacity: The above-mentioned diseases requiring respiratory support, such as: severe chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dystrophy and muscular dystrophy: Respiratory support devices intended for use in these patient populations require a technical report in the event of a loss of essential performance: alert status: In the event of loss of artificial ventilation, the weakest of these patients may be harmed, but not seriously injured or killed Death: For these patients, ventilatory support during waking hours may be required to facilitate Mobility and functional independence in activities of daily living: In this document, the principles of the text marked with an asterisk (*) are explained in Appendix AA; in accordance with ISO 16142-1:2016 See Appendix CC for the basic principles of safety and performance: Medical Electrical Equipment Part 2-80: For Breathing Basic safety and Basic performance-specific requirements 201:1 Scope, purpose and relevant standards Except for the following, Chapter 1 of GB 9706:1-2020 applies: 201:1:1* Scope replace: This document specifies respiratory support equipment (see 201:3:205 definition, also known as the basic safety and essential performance of ME equipment): This document is intended for use by inexperienced operators in patients with respiratory insufficiency or failure Or, operational respiratory support equipment in anticipation of transfer: NOTE 1: The most debilitated of these patients would be harmed by the loss of artificial ventilation: This document also applies to accessories intended by the manufacturer to be connected to breathing systems (VBS for short) of ME equipment, the characteristics of which may Affect the basic safety and essential performance of ME EQUIPMENT: Example 1: breathing circuit, connector, water cup, exhalation valve, humidifier, VBS filter, external power supply and distributed alarm system, etc: This document does not apply to equipment intended for use in patients whose life is supported by artificial ventilation in real time: Example 2: Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia and muscular dystrophy patient: Note 2: When used in a home care environment, the power source is often unreliable: Note 3: This type of respiratory support equipment is also suitable for non-critical patient care in professional healthcare facilities: This document does not apply to critical care ventilators and their accessories: This document does not apply to anesthesia ventilators and their accessories: This document does not apply to emergency and transport ventilators and their accessories: This document does not apply to home ventilators used by ventilator-dependent patients: This document does not apply to respiratory support equipment intended for respiratory dysfunction: This document does not apply to medical electrical equipment for the treatment of obstructive sleep apnea: This document does not apply to continuous positive airway pressure (CPAP) medical electrical equipment: This document does not apply to High Frequency Jet Ventilators (HFJV): This document does not apply to high frequency oscillatory ventilators (HFOV): This document does not apply to constant flow oxygen therapy equipment: This document does not apply to Ironclad and "Iron Lung" ventilators: If a chapter or a clause applies only to me equipment, or only to me systems, the title and text of the chapter or clause will indicate: Otherwise, this chapter or this clause applies to both relevant me equipment and me systems: In addition to 7:2:13 and 8:4:1 in GB 9706:1-2020, the expected physiological effects of ME equipment or ME systems within the scope of this document The hazards inherent in the application are not covered by the specific requirements of this document: Note 4: For more information, see 4:2 in GB 9706:1-2020: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.280-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.280-2023_English as soon as possible, and keep you informed of the progress. 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