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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. JJG 692-2010: Verification regulation of non-invasive automated sphygmomanometers Status: Valid JJG 692: Historical versions
Basic dataStandard ID: JJG 692-2010 (JJG692-2010)Description (Translated English): Verification regulation of non-invasive automated sphygmomanometers Sector / Industry: Metrology & Measurement Industry Standard Classification of Chinese Standard: A53 Classification of International Standard: 17.100 Word Count Estimation: 19,196 Date of Issue: 2010-05-11 Date of Implementation: 2010-11-11 Older Standard (superseded by this standard): JJG 692-1999 Quoted Standard: GB/T 14710-1999; GB 9706.1-2007; YY 0505-2005; ISO 81060-2-2009 Regulation (derived from): AQSIQ Announcement No. 50 of 2010 Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine Summary: This standard applies to oscillometric, noninvasive principle auscultation automatic measuring blood pressure [hereinafter referred to as blood pressure monitors, including non-invasive blood pressure monitors, multi-parameter monitor (NIBP part), ambulatory blood pressure monitors and electronic sphygmomanometer] of the type evaluation, initial verification, testing and use of follow-up inspection. JJG 692-2010: Verification regulation of non-invasive automated sphygmomanometers---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.Verification regulation of non-invasive automated sphygmomanometers State verification procedures People's Republic of China Non-invasive blood pressure measurements automatically Issued on. 2010-05-11 2010-11-11 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Non-invasive measurement of blood pressure monitor automatic verification procedures AutomatedSphyg momanometers Replacing JJG 692-1999 The regulations by the State Administration of Quality Supervision, Inspection and Quarantine approved on May 11, 2010, and from From November 11, 2010 into effect. Focal point. the National Technical Committee of pressure measurement Main drafting unit. Beijing Institute of Metrology detection Shanghai Measurement and Testing Technology Research Institute Participated in the drafting. General Logistics Department of Health Drug and Instrument Control Xi'an Institute of Measurement Haier Qingdao Chia Tai Pharmaceutical Co., Ltd. Fluke International Beijing Office The measurement procedure commissioned the National Technical Committee is responsible for interpreting pressure The main drafters of this procedure. Zhu Junjie (Beijing Institute of Metrology detection) Tu Li Meng (Shanghai Institute of Measurement and Testing) Gao Yang (Beijing Institute of Metrology detection) Drafters participate. Xue Li Yong (General Logistics Department of the Ministry of Health Drug and Instrument Control) Guo Jian (Xi'an Institute of Measurement) Wangming Gang (Haier Qingdao Chia Tai Pharmaceutical Co., Ltd.) Zhang M (Fluke International Beijing Office) table of Contents1 Scope (1) 2. Referenced Documents (1) 3 Terms and Definitions (1) 4 Overview (2) 5 metering performance requirements (2) 5.1 static pressure measurement range (2) 5.2 Static Pressure Indication maximum permissible error (2) 5.3 blood pressure Repeatability (applies to the principle of oscillometric sphygmomanometer) (2) 5.4 automatic release valve deflation rate (applicable to the principles of auscultation sphygmomanometer) (2) 6 General Requirements (2) 6.1 Appearance (2) 6.2 pneumatic system tightness (2) 7 control of measuring instruments (3) 7.1 Type evaluation (3) 7.2 test conditions (3) 7.3 Verification Project (3) 7.4 Verification Methods (4) 7.5 Verification Results Processing (6) 7.6 test cycle (6) A type of evaluation items and test methods Appendix (7) Appendix B automatic noninvasive measurement of blood pressure test records (recommended) format (12) Appendix C test certificate page format (13) Appendix D test results in the notice page format (14) Non-invasive measurement of blood pressure monitor automatic verification procedures1 ScopeThe order applies to oscillometric method, auscultation principle of non-invasive measurement of blood pressure monitor automatically [hereinafter referred to as blood pressure monitors, including Non-invasive blood pressure monitor, multi-parameter monitor (NIBP part), ambulatory blood pressure monitors and electronic sphygmomanometer] of Pattern evaluation, initial verification, subsequent verification and in-service inspection.2 CitationsThe regulations cited in the following documents. GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods GB 9706.1-2007/IEC 60601-1. 1988 Medical electrical equipment - Part 1. General requirements for safety YY0505-2005/IEC 60601-1-2.2001 Medical electrical equipment - Part 1-2. General Security To Seeking Collateral standard. Electromagnetic compatibility requirements and tests ISO 81060-2.2009 Non-invasive sphygmomanometers --- Part 2. Automated measuring type sphygmomanometer clinical validation trials When using this procedure, it should pay attention to using the currently valid version of the documents cited.3 Terms and Definitions3.1 Non-invasive measurement of blood pressure monitor automatic non-invasiveautomatedsphygmomanometer Signal detection means from the cuff or by the sensor device to automatically determine arterial blood pressure in an indirect manner. Note. This non-invasive automatic blood pressure measurement procedure referred to include non-invasive blood pressure monitor, multi-parameter monitor (NIBP section), Ambulatory blood pressure monitors and electronic sphygmomanometer. 3.2 Non-invasive blood pressure monitor non-invasivebloodpressuremonitor, NIBP A function that automatically timed to start blood pressure measurement and recording of blood pressure measurement of non-invasive automatic sphygmomanometer. More than 3.3-parameter monitor multi-parameterpatientmonitor Capable of a variety of basic parameters of the patient's vital signs in real-time monitoring and recording instruments generally include ECG, Non-invasive blood pressure, oxygen, etc., or more parameters. 3.4 Ambulatory Blood Pressure Monitor ambulatorybloodpressuremonitor, ABPM Or in daily living activities, blood pressure measurements may be worn or carried portable real-time monitoring of noninvasive blood pressure Blood Pressure Monitor. 3.5 electronic sphygmomanometer digitalelectronicsphygmomanometer Inflatable cuff procedure is determined by the user manual or automatic sphygmomanometer pressure to complete, and in digital form showing income Systolic pressure and diastolic blood pressure non-invasive automatic measurement. 3.6 Oscillometric oscilometricmethod By blocking the process of inflating and deflating the cuff oscillation measurement, implementation of indirect measurement of arterial blood pressure. 3.7 auscultation auscultatorymethod Korotkoff methods to indirectly measure the blood pressure cuff is deflated by blocking the process to hear. ...... |
