YY/T 1750-2020 PDF EnglishUS$135.00 · In stock · Download in 9 seconds
YY/T 1750-2020: Ultrasonic surgical equipment for soft tissue excision and hemostasia Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 1750-2020: Ultrasonic surgical equipment for soft tissue excision and hemostasia---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1750-2020YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.60 C 41 Ultrasonic surgical equipment for soft tissue excision and hemostasia ISSUED ON: SEPTEMBER 27, 2020 IMPLEMENTED ON: SEPTEMBER 01, 2022 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 4 4 Requirements ... 5 5 Test methods ... 8 Ultrasonic surgical equipment for soft tissue excision and hemostasia1 ScopeThis Standard specifies the requirements and test methods for ultrasonic surgical equipment for soft tissue excision and hemostasia (hereinafter referred to as equipment). This Standard applies to ultrasonic surgical equipment for soft tissue excision and hemostasia. This Standard does not apply to ultrasonic surgical equipment for bone tissue, ultrasonic suction equipment, phacoemulsification equipment, ultrasonic debridement equipment, ultrasonic lithotripsy equipment, and high-intensity ultrasonic therapeutic equipment (HITU).2 Normative referencesThe following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document. GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance GB/T 14710 Environmental requirement and test methods for medical electrical equipment YY/T 0644-2008 Ultrasonics-surgical systems - Measurement and declaration of the basic output characteristics YY 1057 General specifications for medical foot switch YY/T 1420 Environmental requirement and test methods for medical ultrasonic equipment3 Terms and definitionsThe terms and definitions defined in YY/T 0644-2008 and the following ones apply to this document. The maximum output sound power, derived from each cutter head of each ultrasonic hand-held part, shall comply with the requirements published by the manufacturer. 4.5 Static electric power The static electric power of each ultrasonic hand-held part and its deviation shall comply with the requirements published by the manufacturer. 4.6 Maximum electric power The maximum electric power of each ultrasonic hand-held part and its deviation shall comply with the requirements published by the manufacturer. 4.7 Clamping force The maximum clamping force for each tip of each ultrasonic hand-held part shall be greater than the minimum limit published by the manufacturer. 4.8 Grasping force The grasping force of each cutter head of each ultrasonic hand-held part with grasping function shall be greater than the value published by the manufacturer. 4.9 Appearance and structure 4.9.1 The surface of the equipment shall be clean and free from scratches, cracks and other defects. 4.9.2 The text and signs indicating the operation shall be clear, easy to recognize, and durable. 4.9.3 The control and adjustment mechanism shall be flexible and reliable. The fastening parts shall not be loose. 4.10 Use functions The equipment shall have the use functions specified by the manufacturer in the accompanying documents. Note: This article does not involve product design parameters or function items that cannot be verified by intuitive test methods. 4.11 Declaration of output characteristics The following characteristics shall be declared in the accompanying documents: a) The reference tip principal amplitude of each type of cutter head tip (i.e. the maximum tip principal amplitude); T - Declared value or nominal value. Deviation is usually expressed as a percentage. 5.3 Lateral amplitude of tip According to the method specified in 6.2 of YY/T 0644-2008, measure the maximum lateral amplitude of the tip of cutter head. It is also possible to use the laser vibrometer method specified in 6.1.2 of YY/T 0644-2008 to measure. According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value. 5.4 Excitation frequency Measure according to the method specified in 6.3 of YY/T 0644-2008. It is also possible to use an oscilloscope to measure. According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value. 5.5 Derived output sound power Measure according to the method specified in 6.5.1 of YY/T 0644-2008. 5.6 Static electric power Measure according to the method specified in 6.9 of YY/T 0644-2008. According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value. 5.7 Maximum electric power Measure according to the method specified in 6.10 of YY/T 0644-2008. According to formula (1), calculate the deviation between the actual measured value and the manufacturer's declared value or nominal value. 5.8 Clamping force Set a pressure sensor at the tip of cutter head. Its clamping position is specified by the manufacturer. Set the equipment in the state of maximum clamping force. Read the value of the pressure sensor. Repeat 5 times. Take the average value as the maximum clamping force. The test results shall indicate the geometrical position at which the maximum clamping force occurs. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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