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JJF 1626-2017: Calibration Specification for NIBP Simulators
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| JJF 1626-2017 | English | 459 |
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Calibration Specification for NIBP Simulators
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JJF 1626-2017
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Basic data | Standard ID | JJF 1626-2017 (JJF1626-2017) | | Description (Translated English) | Calibration Specification for NIBP Simulators | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A53 | | Word Count Estimation | 20,238 | | Date of Issue | 2017-09-26 | | Date of Implementation | 2017-12-26 | | Regulation (derived from) | General Administration of State Quality Inspection Announcement 2017 No. 78 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine | JJF 1626-2017: Calibration Specification for NIBP Simulators---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 of blood pressure simulator)
People's Republic of China National Measurement Specifications
Blood pressure simulator calibration specification
Calibration Specification for NIBPSimulators
2017-09-26 Posted
2017-12-26 Implementation
General Administration of Quality Supervision, Inspection and Quarantine released
Blood pressure simulator calibration specification
NIBPSimulators
The focal point. National pressure measurement technical committee
The main drafting unit. Beijing Institute of Metrology
General Logistics Department Ministry of Health Pharmaceutical Instrument Inspection Institute
Participated in the drafting unit. Shenzhen China Instrument Technology Co., Ltd.
Watson Instrument (Beijing) Co., Ltd.
This specification entrusts the national pressure measurement technical committee to explain
The main drafters of this specification.
Gao Yang (Beijing Institute of Metrology and Measurement)
Wen Kangming (Beijing Institute of Metrology and Measurement)
Song Li (General Logistics Department of Health Ministry of Drug Instrument Inspection)
Lu Guiliang (Beijing Institute of Metrology and Measurement)
Participate in the drafters.
Jiajian Ge (General Logistics Department Ministry of Health Drug Instrument Inspection Institute)
Le Cheng Wang (Shenzhen China Instrument Technology Co., Ltd.)
Zheng Wei [Watson Instruments (Beijing) Co., Ltd.]
table of Contents
Introduction (Ⅱ)
1 Scope (1)
2 References (1)
3 Terms and measurement units (1)
3.1 Terms (1)
3.2 unit of measure (1)
4 Overview (1)
5 Metrology (1)
5.1 Static pressure range (1)
5.2 Static pressure error (2)
5.3 Simulation of blood pressure range (2)
5.4 blood pressure indication repeatability (2)
5.5 Pulse rate error (2)
5.6 Air tightness (2)
6 Calibration conditions (2)
6.1 Environmental conditions (2)
6.2 Measurement standards and other equipment (2)
7 Calibration Items and Calibration Methods (2)
7.1 Appearance (2)
7.2 static pressure range and indication error (3)
7.3 Simulation of blood pressure range (3)
7.4 blood pressure indication repeatability (4)
7.5 Pulse rate error (5)
7.6 Air tightness (5)
8 Calibration Results (5)
8.1 Calibration records (5)
8.2 Calibration Results Processing (5)
9 time interval of correction (6)
Appendix A Blood Pressure Simulator Calibration Recording Format (7)
Appendix B Calibration Certificate Internal Page Format (9)
Appendix C Blood pressure simulator static pressure calibration results of uncertainty evaluation (11)
Appendix D blood pressure simulator pulse rate calibration results evaluation of uncertainty (13)
Introduction
The drafting of this specification mainly refers to the JJG692-2010 "noninvasive automatic measurement sphygmomanometer" and IEC 80601-
2-30.2013 "Medical electrical equipment - Part 2-30. Noninvasive automatic measurement of sphygmomanometer basic safety and important performance
The special requirements "in the concept and requirements of blood pressure simulator, with reference to several common domestic blood pressure simulator sex
Can parameter and its testing method, combine with domestic actual usage to be made.
At the same time, this code is based on the compilation of JJF 1071-2010 "National Metrology Calibration Code Writing Rules"
JJF 1001-2011 "common measurement terms and definitions", JJF 1008-2008 "pressure measurement term and set
Meaning ", JJF 1059.1-2012" Measurement Uncertainty Evaluation and Expression "and other technical specifications.
This specification is first released.
Blood pressure simulator calibration specification
1 Scope
This calibration standard is suitable for blood pressure simulator calibration.
2 reference documents
This specification cites the following documents.
JJG692-2010 non-invasive automatic measurement sphygmomanometer
For dated references, only the dated version applies to this specification; for undated references
The latest version (including all amendments) applies to this specification.
3 Terms and measurement units
3.1 Terms
3.1.1 non-invasive automatic measurement sphygmomanometer non-invasiveautomatedsphygmomanometer [JJG692-
2010,3.1]
Equipment that automatically determines arterial blood pressure indirectly by detecting signals from cuffs or sensors.
3.1.2 oscillometric methods measureometricmethod [JJG692-2010,3.6]
The method of indirect measurement of arterial blood pressure is achieved by measuring the oscillatory wave in the process of deflation and deflation of the cuff.
3.1.3 blood pressure simulator non-invasivebloodpressuresimulator, NIBPsimulator
Equipment for simulating the cuff pulse wave during inflation and deflation in an oscillometric method.
3.2 unit of measurement
The unit of measurement used is .kPa, kPa, s.
4 Overview
The basic principle of a blood pressure simulator is that it produces an observation that is similar to cuffs tied to the arm when pressurized by blood pressure
To the pulse waveform, and the amplitude and characteristics of the waveform with the pressure in the cuff during pressurization and decompression and regular
Changes have taken place. A set of pulse waves and associated cuff pressure is stored in the simulator, corresponding to a specific set of blood
Pressure (systolic/diastolic) to simulate human blood pressure. Blood pressure simulator is used for non-invasive automatic oscillometric method
Blood pressure measurement of sphygmomanometer range, blood pressure and other performance testing equipment repeatability.
Blood pressure simulator generally consists of input and output units, data processing unit and pressure generating unit and other components, with pressure
Meter, pressure source, analog blood pressure output, leak test, over-voltage test and other functions.
5 measurement characteristics
5.1 Static pressure range
At least should meet (0.0 ~ 53.3) kPa.
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