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JJF 1259-2018 English PDF

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JJF 1259-2018: Calibration Specification for Syringe Pumps and Infusion Pumps
Status: Valid

JJF 1259: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
JJF 1259-2018English329 Add to Cart 3 days [Need to translate] Calibration Specification for Syringe Pumps and Infusion Pumps Valid JJF 1259-2018
JJF 1259-2010English599 Add to Cart 3 days [Need to translate] Calibration specification for syringe pumps and infusion pumps Obsolete JJF 1259-2010
JJF 1259-1990English199 Add to Cart 2 days [Need to translate] O.T.N. of the Secondary Standard for the Density(Alcoholometer) Obsolete JJF 1259-1990

PDF similar to JJF 1259-2018


Standard similar to JJF 1259-2018

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Basic data

Standard ID JJF 1259-2018 (JJF1259-2018)
Description (Translated English) Calibration Specification for Syringe Pumps and Infusion Pumps
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 14,125
Date of Issue 2018-02-27
Date of Implementation 2018-08-27
Older Standard (superseded by this standard) JJF 1259-2010
Regulation (derived from) AQSIQ Announcement No. 26 of 2018
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine

JJF 1259-2018: Calibration Specification for Syringe Pumps and Infusion Pumps

---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.
(Medical syringe pump and infusion pump calibration specifications) National Metrology Technical Specification of the People's Republic Medical syringe pump and infusion pump calibration specifications Published on.2018-02-27 2018-08-27 implementation The General Administration of Quality Supervision, Inspection and Quarantine issued Medical syringe pump and infusion pump Calibration specification Replace JJF 1259-2010 Focal Point. National Medical Metrology Technical Committee Drafted by. China Institute of Metrology Wuxi Metrology Verification Test Center Fujian Institute of Metrology This Code entrusts the National Medical Metrology Technical Committee to explain Drafters of this specification. Zhu Jianping (China Institute of Metrology) Shi Min (Wuxi Metrology Verification Test Center) Chen Weihuang (Fujian Institute of Metrology) Sun Wei (China Institute of Metrology) Li Wei (Fujian Institute of Metrology)

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 terms and units of measurement (1) 3.1 Flow (1) 3.2 Blocking alarm threshold (pressure) (1) 3.3 Medium speed (1) 4 Overview (1) 5 Measurement characteristics (1) 5.1 Traffic (1) 5.2 Blocking Alarm Error (2) 6 Calibration conditions (2) 6.1 Environmental conditions (2) 6.2 Calibration Media (2) 6.3 Measurement standards and other equipment (2) 7 Calibration items and calibration methods (3) 7.1 Appearance and Functional Inspection (3) 7.2 Flow relative indication error (3) 7.3 Flow indication repeatability (3) 7.4 Blocking Alarm Error (3) 8 calibration result expression (4) 9 re-study interval (4) Appendix A Calibration Record (Recommended) for Medical Syringe Pump and Infusion Pump (5) Appendix B Calibration Certificate Inner Page (Recommended) Format (6) Appendix C Example of Uncertainty Evaluation of Flow Injection Relative Indication Error Measurement Results of Medical Syringe Pumps and Infusion Pumps (7)

Introduction

This specification is a revision of JJF 1259-2010 "Guidelines for Calibration of Medical Syringe Pumps and Infusion Pumps". JJF 1071-2010 "National Metrology Calibration Specification Writing Rules", JJF 1001-2011 "General Measurement Terms and Definition", JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Representation" together constitute the support of this calibration specification revision The basic series of work. Compared with JJF 1259-2010, in addition to editorial changes, the main technical changes of this specification are as follows. --- Modified according to the requirements of JJF 1071-2010 "National Metrology Calibration Specification Writing Rules"; --- Added introduction content; --- Based on modifications to calibration items and calibration methods, reference documents, terminology and measurement standards and others Equipment has been increased, reduced and modified (see 2, 3, Table 2); --- Specification of the representation of the flow range in Tables 1 and 2; --- According to the provisions of JJG1098-2014 "medical syringe pump and infusion pump detector", revised and improved Table 2 The requirements for maximum allowable error, repeatability and resolution of medical syringe pumps and infusion pump detectors; --- Removed the requirement that "the syringe or infusion tube used in the calibration process should be compatible with the instrument being calibrated"; --- Removed a variety of alarm functions and leakage current detection items that are not related to metering performance; --- Improve the calibration method of flow relative indication error (see 7.2); --- Modify the calculation method of flow indication repeatability from Bessel method to range method (see 7.3); --- Increased flow regulations when performing blocking alarm error calibration (see 7.4); --- Move the contents of Appendix C into the body of the specification (see 8). The previous versions of this specification were released. ---JJF 1259-2010. Medical syringe pump and infusion pump calibration specifications

1 Scope

This specification applies to medical syringe pumps (hereinafter referred to as syringe pumps) and medical volumetric infusion pumps (hereinafter referred to as infusion) Calibration of the pump).

2 reference files

This specification refers to the following documents. JJG1098-2014 medical syringe pump and infusion pump detector JJF 1004-2004 Flowmeter terminology and definition GB 9706.27 Medical electrical equipment - Part 2-24. Safety requirements for infusion pumps and infusion controllers GB/T 6682 analytical laboratory water specifications and test methods For dated references, only dated versions apply to this specification; undated quotations The latest version (including all amendments) applies to this specification.

3 terms and units of measure

3.1 Traffic flowrate The volume of fluid flowing through the cross section of the pipe per unit time, in mL/h. 3.2 Blocking alarm threshold (pressure) occlusionalarmthreshold (pressure) The physical quantity value when the blocking alarm is triggered, in kPa. Note. Also commonly used mmHg, 1mmHg ≈ 0.1333kPa. 3.3 medium speed intermediateate The definition is as follows. --- For the infusion pump, the speed is set to 25mL/h; --- For the syringe pump, the speed is set to 5mL/h; --- For special use equipment and portable infusion pumps, set the speed specified by the manufacturer as the standard of the equipment speed.

4 Overview

Syringe pumps and infusion pumps are generally composed of power source, mechanical transmission, electrical control and other components. They can be set Certain parameters (such as capacity, time and flow) are set to control the flow rate of the infusion and the total infusion volume, with an audible and visual alarm And other functions.

5 Measurement characteristics

5.1 Traffic The maximum allowable error and repeatability of the flow rate indication of the syringe pump and infusion pump shall be in accordance with Table 1.

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