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JJF 1753-2019: Calibration Specification for Medical Pressure Pulse Lithotripsy Machines
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Basic data

Standard ID JJF 1753-2019 (JJF1753-2019)
Description (Translated English) Calibration Specification for Medical Pressure Pulse Lithotripsy Machines
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A59
Classification of International Standard 17.140
Word Count Estimation 16,141
Date of Issue 2019
Date of Implementation 2019-12-27
Issuing agency(ies) State Administration for Market Regulation

JJF 1753-2019: Calibration Specification for Medical Pressure Pulse Lithotripsy Machines


---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.
(Calibration specification for medical extracorporeal pressure pulse lithotripter) National Measurement Technical Specification of the People's Republic of China Calibration specification for medical extracorporeal pressure pulse lithotripter 2019-09-27 release 2019-12-27 Implementation Issued by the State Administration of Market Supervision and Administration Medical external pressure pulse stone crusher Calibration specifications Centralized unit. National Acoustic Metrology Technical Committee Main drafting unit. Jiangsu Academy of Metrology Zhejiang Academy of Metrology Participated in the drafting unit. Shenzhen Huikang Medical Devices Co., Ltd. Jiangsu Medical Device Inspection Institute Nanjing Gulou Hospital Jiangsu Provincial Hospital of Traditional Chinese Medicine This specification is entrusted to the National Acoustic Metrology Technical Committee for interpretation The main drafters of this specification. Wang Peng (Jiangsu Institute of Metrology) Xu Zhaoqian (Zhejiang Institute of Metrology) Xia Xunrong (Jiangsu Institute of Metrology) Participating drafters. Jiang Zhancheng (Shenzhen Huikang Medical Devices Co., Ltd.) Chen Tao (Jiangsu Medical Device Inspection Institute) Yang Yuzhi (Nanjing Gulou Hospital) Yan Yu (Jiangsu Traditional Chinese Medicine Hospital)

table of Contents

Introduction (Ⅲ) 1 Scope (1) 2 References (1) 3 Terms and units of measurement (1) 3.1 Gravel (1) 3.2 Pressure pulse (1) 3.3 Focus (1) 3.4 Focal volume (1) 3.5 Maximum focal length (1) 3.6 Pulse width of positive sound pressure (1) 3.7 Pressure pulse rise time (1) 3.8 Pressure pulse generator (1) 3.9 Minimum displacement of positioning device (2) 4 Overview (2) 5 Metrological characteristics (2) 5.1 Peak sound pressure (2) 5.2 Repeatability of peak sound pressure output (2) 5.3 Pulse width of positive sound pressure (2) 5.4 Rise time of pressure pulse (2) 5.5 Geometrical dimensions of the focal area (2) 5.6 Distance from focus to generator end face (2) 5.7 Deviation of focus and target mark (2) 5.8 Minimum displacement of positioning device (3) 6 Calibration conditions (3) 6.1 Environmental conditions (3) 6.2 Calibration equipment (3) 7 Calibration items and calibration methods (3) 7.1 Preparations before calibration (3) 7.2 Peak sound pressure (3) 7.3 Peak sound pressure output repeatability (5) 7.4 Pulse width of positive sound pressure (5) 7.5 Pressure pulse rise time (5) 7.6 Geometry of the focal area (5) 7.7 Distance from focus to generator end face (5) 7.8 Deviation of focus and target mark (5) 7.9 Minimum displacement of positioning device (5) 8 Expression of calibration results (6) 8.1 Calibration records (6) 8.2 Calibration certificate (6) 8.3 Measurement uncertainty of calibration results (6) 9 Recalibration interval (6) Appendix A Internal Page Format of Calibration Certificate for Medical Extracorporeal Pressure Pulse Lithotripter (7) Appendix B Example of measurement uncertainty evaluation of medical extracorporeal pressure pulse lithotripter (8)

Introduction

This specification is based on the rules and format given in JJF 1071-2010 "Rules for Compiling National Measurement and Calibration Specifications" prepared by. The standard reference GB/T 16407-2006 "Acoustic medical external pressure pulse lithotripter sound field characteristics and measurement Volume ", GB 9706.22-2003" Medical Electrical Equipment Part 2. Safety Requirements for In Vitro Lithotripsy Equipment " Requirement and other relevant domestic and foreign standards are formulated. This specification is the first release. Calibration specification for medical extracorporeal pressure pulse lithotripter

1 Scope

This specification applies to the calibration of electromagnetic medical external pressure pulse lithotripters. Hydroelectric and piezoelectric medical extracorporeal pressure pulse lithotripters can be implemented with reference to this specification.

2 Reference documents

This specification refers to the following documents. JJF 1001-2011 General Measurement Terms and Definitions JJF 1034-2005 Acoustic measurement terms and definitions GB 3102.7-1993 Acoustic quantities and units GB 9706.1-2007 Medical electrical equipment Part 1. General requirements for safety GB 9706.22-2003 Medical electrical equipment Part 2. Particular requirements for the safety of in vitro lithotripsy equipment GB/T 16407-2006 Acoustic medical external pressure pulse lithotripter sound field characteristics and measurement YY0001-2008 Technical requirements for in vitro lithotripsy equipment For dated reference documents, only the dated version applies to this specification; for those without date references The latest version (including all amendments) is applicable to this specification.

3 Terms and units of measurement

3.1 Lithotripsy Crushing or breaking of human stones. 3.2 Pressure pulse pressurepulse Sound pressure pulses generated by medical lithotripters. 3.3 focus In the pressure pulse sound field, the position of the maximum positive peak sound pressure. 3.4 Focal volume The volume of the space enclosed by the interface 6dB lower than the maximum positive peak sound pressure (0dB) around the focal point. 3.5 Maximum focal width In the (x, y) plane containing the focal point, the maximum sound pressure line around the focal point is 6dB lower than the maximum positive peak sound pressure. Large width. 3.6 Width of positive sound pressure pulse widthofpressurepulse Before and after the peak value of the sound pressure pulse, the sound pressure value is equal to the time difference between the two instantaneous sound pressures of 50% of the peak value of the pulse, in units For seconds (s). 3.7 Rise time of pressure pulse risetimeofpressurepulse The time from 10% of the positive peak of the pressure pulse to 90%, in seconds (s). 3.8 Pressure pulse generator generatorofpressurepulse ...

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