YY/T 1830-2022 English PDFUS$399.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1830-2022: Electrical pneumatic tourniquet equipment Status: Valid
Basic dataStandard ID: YY/T 1830-2022 (YY/T1830-2022)Description (Translated English): Electrical pneumatic tourniquet equipment Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30;C49 Word Count Estimation: 19,187 Issuing agency(ies): State Drug Administration YY/T 1830-2022: Electrical pneumatic tourniquet 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.Electrical pneumatic touriquet equipment ICS 11.040.01 CCSC30/49 People's Republic of China Pharmaceutical Industry Standard Electric pneumatic hemostat Published on 2022-05-18 2023-05-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Definitions and terms 1 4 Requirements 2 4.1 Working conditions 2 4.2 Material Requirements 2 4.3 Performance Index 2 4.4 Inflation pressure requirements 3 4.5 Timing function 3 4.6 Requirements for air source 3 4.7 Airbags and Pneumatic Tourniquets 4 4.8 Pneumatic tourniquet with balloon 4 4.9 Requirements for the use of pneumatic tourniquets 4 4.10 Interface requirements for gas pipelines 4 4.11 System Leak 4 4.12 Requirements for pressure balance function 5 4.13 Prompt/Alarm function 5 4.14 Mobility performance (if applicable) 5 4.15 Functional requirements for multi-channel models5 4.16 Unexpected power outage 5 4.17 Maximum noise5 4.18 Internal power charging indication 5 4.19 Environmental test 5 4.20 Electrical Safety Requirements 6 4.21 Electromagnetic compatibility 6 4.22 Requirements for alarms 6 5 Test method 6 5.1 Test conditions 6 5.2 Performance Index 6 5.3 Inflation pressure requirements 6 5.4 Timing function 7 5.5 Requirements for air source 7 5.6 Airbags and pneumatic tourniquets 8 5.7 Pneumatic tourniquet with bladder 9 5.8 Requirements for the use of pneumatic tourniquets 9 5.9 Interface requirements for gas pipelines 9 5.10 System leakage 9 5.11 Requirements for pressure balance function 9 5.12 Prompt/alarm function 10 5.13 Mobility performance (if applicable) 10 5.14 Functional requirements for multi-channel models 10 5.15 Accidental power outage 10 5.16 Maximum noise 10 5.17 Internal power charging indication 10 5.18 Environmental test 10 5.19 Electrical safety requirements 10 5.20 Electromagnetic compatibility 10 5.21 Requirements for alarms 11 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. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) focal point. This document is drafted by. Shanghai Medical Device Testing Institute, Zhejiang Medical Device Evaluation Center, Hangzhou Zhengda Medical Device Co., Ltd., Shanghai Changning Medical Technology Co., Ltd. The main drafters of this document. Zhao Yang, Zhu Wenwu, Yan Hongcheng, Hu Kai, Zheng Feixiang. Electric pneumatic hemostat1 ScopeThis document specifies the requirements and test methods for electropneumatic hemostatic devices. This document applies to electro-pneumatic compression blocking hemostatic equipment in limb surgery. This document does not apply to hemostatic equipment specially used for femoral artery hemostasis, nor does it apply to passive manual inflatable hemostatic equipment. Refer to this document as applicable.2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Parallel Standard Electromagnetic capacity requirements and tests YY 9706.108 Medical Electrical Equipment Part 1-8.General Requirements for Basic Safety and Essential Performance Collateral Standard. General Requirements requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems3 Definitions and TerminologyThe terms and definitions defined in GB 9706.1 and the following terms and definitions apply to this document. 3.1 It is used for limb surgery, which uses air pressure compression to temporarily block the blood flow of limbs near the bleeding site of the limbs, so as to achieve Active medical devices for hemostasis. 3.2 Air pressure touriquet The utility model relates to a long-belt-shaped inflatable part wrapped around the limbs requiring hemostasis when air pressure is used for hemostasis in the operation of the limbs. 3.3 airbag A gas medium is filled in a flexible bladder cavity, and the elastic action part is realized by utilizing the gas compressibility. 3.4 pressure resistance A mechanical limit used to evaluate a pipeline or cavity structure under internal gas pressure without changing its sealing properties. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1830-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 1830-2022_English as soon as possible, and keep you informed of the progress. 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