YY 9706.287-2025 English PDFUS$2139.00 ยท In stock
Delivery: <= 10 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.287-2025: Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators Status: Valid
Basic dataStandard ID: YY 9706.287-2025 (YY9706.287-2025)Description (Translated English): Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 106,144 Date of Issue: 2025-02-26 Date of Implementation: 2028-03-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies the basic safety and basic performance of high-frequency ventilators (HFVs) (hereinafter referred to as ME equipment) used in combination with accessories. This standard applies to high-frequency ventilators that are intended to be operated by professional medical personnel in professional medical institutions to provide professional care for patients whose conditions may be life-threatening and require comprehensive care and continuous monitoring, and to provide more than 150 times/min of inflation to patients requiring different levels of artificial ventilation support (including patients who are dependent on ventilators). This standard also applies to accessories that the manufacturer intends to connect to HFV breathing systems or high-frequency ventilators, the characteristics of which may affect the basic safety or essential performance of high-frequency ventilators. If a chapter or a clause clearly states that it is only applicable to ME equipment or only to ME systems, the title and the body of the chapter or clause will say so. YY 9706.287-2025: Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators---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. ICS 11.040.10 CCSC46 Pharmaceutical Industry Standards of the People's Republic of China Medical electrical equipment Part 2-87.High frequency respiration Particular requirements for basic safety and essential performance of machines (ISO 80601-2-87.2021,MOD) Released on 2025-02-26 2028-03-01 Implementation The State Drug Administration issued Table of contentsPreface III Introduction V 201.1 Scope, purpose and related standards 1 201.2 Normative references 3 201.3 Terms and Definitions 4 201.4 General requirements 18 201.5 General requirements for testing of ME equipment 19 201.6 Classification of me equipment and me systems 20 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 20 201.8 Protection of ME EQUIPMENT against hazards of electric shock 24 201.9 Protection of me equipment and me systems against mechanical hazards 24 201.10 Protection against the dangers of unwanted or excessive radiation 27 201.11 Protection against overtemperature and other hazards (sources) 27 201.12 Accuracy of controls and instruments and protection against hazardous outputs 30 201.13 Hazardous conditions and fault conditions of ME equipment 41 201.14 Programmable electrical medical systems (PEMS) 42 201.15 Construction of ME EQUIPMENT 43 201.16 ME System 45 201.17 Electromagnetic compatibility of me equipment and me systems 45 201.101 Gas connection 45 201.102 Requirements for HFV breathing systems and accessories 47 201.103 * Spontaneous breathing during energy loss 48 201.104 * Indication of operating duration 48 201.105 Functional Connection 48 201.106 Display Ring Graph 49 201.107 Limited time high frequency oscillation pause 49 202 Electromagnetic Interference --- Requirements and Tests 49 206 Availability 50 208 General Requirements, Tests and Guidance for Alarm Systems in ME EQUIPMENT and ME SYSTEMS 51 Annex C (informative) Guidance on marking and identification requirements for me equipment and me systems 53 Appendix D (Informative) Marking Symbols 57 Appendix AA (Informative) Specific guidance and basic principles 58 Appendix BB (Informative) Data Interface Requirements 78 Annex CC (informative) Reference to the International Medical Device Regulators Forum and Labelling Guidelines 83 Appendix DD (Informative) Basic Principles Index 87 Appendix EE (informative) General safety and performance requirements Index 90 References 94ForewordThis 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.Particular requirements. This document is Part 2-87. This document is modified to adopt ISO 80601-2-87.2021 "Medical electrical equipment - Part 2-87.Basic safety and basic requirements for high-frequency ventilators" This performance-specific requirements. The technical differences between this document and ISO 80601-2-87.2021 and their reasons are as follows. --- IEC 60068-2-27.2008 was replaced by the normative reference GB/T 2423.5-2019 to adapt to my country's technical conditions; --- IEC 60068-2-31.2008 was replaced by the normative reference GB/T 2423.7-2018 to adapt to my country's technical conditions; --- IEC 60068-2-64.2008 was replaced by the normative reference GB/T 2423.56-2018 to adapt to my country's technical conditions; --- Replaced ISO 3744.2010 with the normative reference GB/T 3767-2016 to adapt to my country's technical conditions; --- IEC 61672-1.2013 was replaced by the normative reference GB/T 3785.1 to adapt to my country's technical conditions; --- Replaced IEC 60529.1989 AMD1.1999 AMD2.2013 with the normative reference GB/T 4208 to adapt to our Technical conditions of the country; ---Replaced IEC 60601-1.2005 AMD1.2012 AMD2 with normative references GB 9706.1-2020. 2020, to adapt to the technical conditions of our country; --- Replaced ISO 80601-2-55.2018 with the normative reference GB 9706.255-2022 to adapt to my country's technical conditions; --- Replaced ISO 7396-1.2016 with the normative reference GB/T 44059.1 to adapt to my country's technical conditions; --- Replaced ISO 4871.1996 with the normative reference GB/T 14574-2000 to adapt to my country's technical conditions; --- Replaced ISO 14937.2009 with the normative reference GB/T.19974 to adapt to my country's technical conditions; --- ISO 7010 was replaced by the normative reference GB/T 31523.1 to adapt to my country's technical conditions; --- ISO 32.1977 was replaced by the normative reference GB 50751 to adapt to my country's technical conditions; --- Replaced ISO 23328-1.2003 with the normative reference YY/T 0753.1 to adapt to my country's technical conditions; --- Replaced ISO 23328-2.2002 with the normative reference YY/T 0753.2 to adapt to my country's technical conditions; --- Replaced ISO 5359.2014 with the normative reference YY/T 0799 to adapt to my country's technical conditions; --- Replaced ISO 17664.2017 with the normative reference YY/T 0802 to adapt to my country's technical conditions; --- Replaced ISO 80369-1.2018 with the normative reference YY/T 0916.1 to adapt to my country's technical conditions; --- ISO 5356-1 was replaced by the normative reference YY/T 1040.1 to adapt to my country's technical conditions; --- IEC 62366-1.2015 was replaced by the normative reference YY/T 1474 to adapt to my country's technical conditions. --- Replaced ISO 18562-1.2017 with the normative reference YY/T 1778.1 to adapt to my country's technical conditions; --- Replaced ISO 80601-2-74 with the normative reference YY 9706.274-2022 to adapt to my country's technical conditions; The following editorial changes were also made to this document. --- IEC 60601-1-10 was replaced by the informative reference YY/T 9706.110 to adapt to my country's technical conditions (see Appendix AA.1); --- IEC 60601-1-11.2015 was replaced by the informative reference YY 9706.111-2021 to adapt to my country's technical conditions (See Appendix AA.1); ---Replaced IEC 60601-1-12.2014 with the informative reference YY 9706.112-2021 to adapt to my country's technical conditions (See Appendix AA.1); --- Replaced ISO 80601-2-84.2020 with the informative reference YY 9706.284-2023 to adapt to my country's technical conditions (See Appendix AA.1). --- Added the release year of ISO 4135, modified the terminology source, changed 3.6.1.4 to 3.6.1.5, 3.1.4.13 to 3.1.4.15, 3.1.4.19 changed to 3.1.4.21, 3.1.4.22 changed to 3.1.4.24, 3.1.4.39.4 changed to 3.1.4.41.4, 3.1.4.47 changed to 3.1.4.48, 3.1.5.20 changed to 3.1.5.19 (see.201.3.208,.201.3.209,.201.3.222,.201.3.223,.201.3.227, 201.3.247,201.3.251,201.3.252,201.3.260,201.3.267,201.3.280); ---Added the release year YY 9706.274, and corrected the editorial error in the term source, changing.201.3.214 to 201.3.209 (see.201.3.235); --- Modified the editorial error in the term source, changing 3.17 to 3.16 (see.201.3.269); --- Deleted Appendix FF term index. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).IntroductionThe medical electrical equipment safety standards are also called the 9706 series of standards, which consist of general standards, parallel standards, special standards, guidelines and interpretations. ---General standards. safety standards that should be generally applicable to medical electrical equipment, that is, equipment that meets the definition of medical electrical equipment should meet this Basic standards. --- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to those with certain specific functions or characteristics. Only devices that are suitable for this purpose need to meet such standard requirements. ---Special standards. safety standards that apply to a certain type of medical electrical equipment, and not all medical electrical equipment has a special standard. standard. ---Guidelines and interpretations. application guidance and interpretations of relevant requirements in the standards involved. Items marked with an asterisk (*) in this document have specific guidance and rationale related to that item in Appendix AA. The relevant contents are considered to be helpful for the correct application of this specific standard, and any version will be revised when the clinical application changes or the technology is updated. It will also be used when making necessary revisions. Medical electrical equipment Part 2-87.High frequency respiration Particular requirements for basic safety and essential performance of machines 201.1 Scope, purpose and related standards Except as follows, Chapter 1 of the general standard applies. Note. The general standard is GB 9706.1-2020. 201.1.1 *Scope replace. This document specifies the basic safety and essential requirements of high frequency ventilators (HFV) (hereinafter referred to as "ME EQUIPMENT") used in combination with accessories. performance. This document is intended for use in professional medical institutions by professional medical personnel for patients whose conditions may be life-threatening and require comprehensive Provide professional nursing care to patients requiring varying levels of artificial ventilation support (including ventilator-dependent patients) A high-frequency ventilator that provides inflations in excess of 150 times/min. NOTE 1 In this document, such environments are referred to as critical care environments. High-frequency ventilators used in such environments are considered life-sustaining equipment. NOTE 2 For the purposes of this document, such high-frequency ventilators are capable of providing transport within a specialized medical facility (e.g., as a ventilator that can be operated during transport). NOTE 3.High-frequency ventilators used for transport within a specialized healthcare setting are not considered ventilators for use in an emergency medical services setting. Note 4.There are three main names for HFV. ---High frequency percussion ventilation (HFPV, typical HFV frequency is 60 times/min~1000 times/min); --- High frequency jet ventilation (HFJV, typical HFV frequency is 100 times/min~1500 times/min); and ---High frequency oscillatory ventilation (HFOV, typical HFV frequency is 180 times/min~1200 times/min, usually with an active expiratory phase). In addition, the nomenclature of HFV may be combined or used in conjunction with ventilators with a ventilation rate of less than 150 breaths/min. *A high-frequency ventilator is not considered a physiological closed-loop control system unless it uses patient physiological variables to adjust ventilation therapy settings. This document also applies to accessories that the manufacturer intends to be connected to a HFV breathing system or high-frequency ventilator and whose characteristics may affect Affect the basic safety or basic performance of the high-frequency ventilator. If a chapter or clause explicitly states that it applies only to ME EQUIPMENT or only to ME SYSTEMS, the title and the body of the chapter or clause will state this. If not explicitly stated, the relevant clause or subclause applies to both ME EQUIPMENT and ME SYSTEMS. In addition to 7.2.13 and 8.4.1 of the general standard, the intended physiological effects of ME EQUIPMENT or ME SYSTEMS within the scope of this document shall result in Hazards There are no specific requirements in this document. NOTE 5.For additional information, see 4.2 of the general standard. This document does not apply to. --- ME EQUIPMENT intended only to enhance the ventilation of spontaneously breathing patients in professional healthcare settings; ---Non-high frequency ventilators and their accessories for routine ventilation in critical care environments; NOTE 6 HFV may include conventional critical care ventilator operating modes, in which case GB 9706.212-2020 applies to these modes. ---Anesthetic ventilators and their accessories; --- Ventilators and their accessories for use in emergency medical services environments; NOTE 7.HFV may include the functionality of an EMS ventilator. --- Home ventilators and their accessories that rely on patient ventilators; --- Respiratory support equipment and accessories for respiratory dysfunction and respiratory insufficiency; ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.287-2025_English be delivered?Answer: Upon your order, we will start to translate YY 9706.287-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 10 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY 9706.287-2025_English with my colleagues?Answer: Yes. The purchased PDF of YY 9706.287-2025_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. |
