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JJG 1098-2014 English PDF

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JJG 1098-2014: Verification Regulation of Medical Syringe Pump and Infusion Pump Analyzers
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Basic data

Standard ID JJG 1098-2014 (JJG1098-2014)
Description (Translated English) Verification Regulation of Medical Syringe Pump and Infusion Pump Analyzers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Classification of International Standard 17.020
Word Count Estimation 20,241
Date of Issue 8/1/2014
Date of Implementation 11/1/2014
Quoted Standard JJF 1259-2010; GB/T 6682-2008
Regulation (derived from) AQSIQ Notice 2014 No. 89
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine
Summary This Standard applies to medical syringe pump and infusion pump detector initial verification, verification and subsequent use of checks.

JJG 1098-2014: Verification Regulation of Medical Syringe Pump and Infusion Pump Analyzers

---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 Medical Syringe Pump and Infusion Pump Analyzers State verification procedures People's Republic of China Medical syringe pump and infusion pump tester Issued on. 2014-08-01 2014-11-01 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Medical syringe pump and infusion pump tester Verification Regulation Focal point. the National Technical Committee on Clinical Measurement The main drafting units. China Testing Technology Research Institute Supervision and Testing Nanjing hospital Measurement and Testing Center in Wuxi City Participated in the drafting unit. Dalian metrological verification tests Xinjiang Institute of Metrology The measurement procedure commissioned the National Technical Committee responsible for the interpretation of clinical medicine The main drafters of this procedure. Zhang from China (China Testing Technology Research Institute) Hu Ning (Nanjing Supervision and Testing Institute) SHI Min (Wuxi Metrology) Drafters participate. Gong Lan (China Testing Technology Research Institute) Lei (Dalian metrological verification tests) Li Feng (Xinjiang Institute of Measurement and Testing) Lin Tao (China Testing Technology Research Institute)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) Flow rate 3.1 (1) 3.2 cumulative flow (1) 3.3 occlusion pressure (1) 4 Overview (1) 5 metering performance requirements (1) Flow rate 5.1 (1) 5.2 cumulative flow (2) 5.3 occlusion pressure (2) 6 General Requirements (2) 6.1 Appearance (2) 6.2 Identification (2) 6.3 Display (2) 7 control of measuring instruments (2) 7.1 verification Conditions (2) 7.2 Verification Project (3) 7.3 Verification Methods (3) 7.4 Verification Results Processing (6) 7.5 test cycle (6) Appendix A test pattern original record format (7) B test certificates/test results in the notice page format Shape appendix (10) Appendix C water density table (13)

Introduction

JJF1001-2011 "common measurement terms and definitions", JJF1002-2010 "national verification procedures to prepare Rules ", JJF1059.1-2012" Evaluation and Expression of Uncertainty in Measurement ", JJF1259-2010" medical syringe pump And infusion pump calibration standard "constitute the support of the verification protocol development on the basis of a series of documents. Medical syringe pump And measurement of the performance of infusion pumps detector using JJF1259-2010, including traffic congestion and pressure, the cumulative increase Flow requirements. This procedure was first formulated. Medical syringe pump and infusion pump detector test procedures

1 Scope

The order applies to medical injection pump and infusion pump tester (hereinafter referred to as the detector) initial verification, follow-up inspection And given the use of checks. 2. References This procedure references the following documents. JJF1259-2010 medical injection pump and infusion pump calibration specification Laboratory use specifications and test methods GB/T 6682-2008 Analysis For dated references, only the dated edition applies to this procedure; undated reference documents Member, the latest edition (including any amendments) applies to this procedure.

3 terminology and units of measurement

3.1 Traffic flowrate The volume of fluid flow per unit time of the pipe cross-section, in units of mL/h. [JJF1259-2010 Definition 3.1] 3.2 cumulative flow totalflow Over a period of time the volume of fluid flowing through the pipe cross-section, measured in mL. 3.3 occlusion pressure occlusionpressure In the pipe blocked, the pressure on the liquid wall, the unit is kPa.

4 Overview

Detector is used for a medical infusion pump and syringe pump flow and pressure parameters were measured, special measurement calibration Instrument, measure the flow of medical infusion pump and syringe pump output through the built-in liquid flow and pressure sensors, tubes Channel parameters such as pressure, mainly by the liquid sample, a pressure measurement module, a timer, a signal processing unit, the display unit And the like.

5 metering performance requirements

5.1 Flow Detector flow permissible errors in line with the provisions of 6.4 JJF1259-2010 in Table 1. Table 1 Traffic Flow range (mL/h) maximum permissible error Repeatability Resolution (mL/h) [5,20) ± (2.0% reading a division value) 1.0% 0.01 [20,200] ± (1.0% reading a division value) of 0.5% or 0.1 0.01 * (200,1000] ± (2.0% reading a division value) 0.1 1.0% Note. "*" requires a minimum flow indication has four significant figures.

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