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JJF 1844-2020 English PDF

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JJF 1844-2020: (Calibration specification for continuous blood purification device)
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JJF 1844-2020579 Add to Cart 5 days (Calibration specification for continuous blood purification device) Valid

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Basic data

Standard ID: JJF 1844-2020 (JJF1844-2020)
Description (Translated English): (Calibration specification for continuous blood purification device)
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A50
Word Count Estimation: 25,270
Date of Issue: 2020-07-02
Date of Implementation: 2021-01-02
Regulation (derived from): Announcement No. 29 (2020) of the State Administration for Market Regulation
Issuing agency(ies): State Administration for Market Regulation

JJF 1844-2020: (Calibration specification for continuous blood purification device)

---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 continuous blood purification device) National Metrology Technical Specification of the People's Republic of China Specification for calibration of continuous blood purification devices Published on 2020-07-02 2021-01-02 Implementation Released by the State Administration for Market Regulation Specification for calibration of continuous blood purification devices Focal Point. National Medical Metrology Technical Committee Main drafting unit. Guangzhou Institute of Metrology and Testing Technology China Institute of Metrology Participating in the drafting unit. Hangzhou Quality and Technical Supervision and Inspection Institute This specification entrusts the National Medical Metrology Technical Committee to be responsible for the interpretation The main drafters of this specification. Hu Liangyong (Guangzhou Institute of Metrology and Testing Technology) Zheng Chunxiong (Guangzhou Institute of Metrology and Testing Technology) Sun Jie (China Institute of Metrology) Participating drafters. Jiang Xueping (Hangzhou Institute of Quality and Technical Supervision and Inspection)

content

Introduction (Ⅱ) 1 Scope(1) 2 References (1) 3 Terms (1) 4 Overview(1) 5 Metrology Characteristics(2) 6 Calibration Conditions(2) 6.1 Environmental conditions (2) 6.2 Calibration medium(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 Blood pump flow(3) 7.3 Dialysate pump flow (3) 7.4 Displacement pump flow (4) 7.5 Anticoagulation pump injection flow (5) 7.6 Venous (arterial) pulse pressure (6) 7.7 Transmembrane pressure(6) 7.8 Weighing scales (6) 7.9 Dehydration rate(7) 7.10 Liquid balance error(7) 8 Expression of calibration results (7) 8.1 Calibration records (7) 8.2 Processing of calibration results (7) 9 Recalibration interval(8) Appendix A Continuous Blood Purification Device Calibration Original Record (Recommended) Format (9) Appendix B Calibration Certificate Inner Page (Recommended) Format (15) Appendix C Measurement Uncertainty Evaluation Example(17)

Introduction

The compilation of this specification is based on JJF 1071-2010 "Rules for Compilation of National Metrology Calibration Specifications", JJF 1001-2011 "General Metrology Terms and Definitions", JJF 1059.1-2012 "Measurement Uncertainty Evaluation and Representation" as the basis and in accordance with. This specification is compiled with reference to YY0645-2018 "Continuous Blood Purification Equipment". This specification is published for the first time. Specification for calibration of continuous blood purification devices

1 Scope

This specification applies to continuous blood purification devices, including those that can be used for continuous hemofiltration for 24 hours or more and other blood purification treatment devices. This specification does not apply to peritoneal dialysis devices, hemodialysis devices, blood perfusion devices, and plasma therapy devices.

2 Reference documents

This specification references the following documents. GB/T 6682-2008 Specifications and test methods for water used in analytical laboratories GB 9706.2-2003 Medical Electrical Equipment Part 2-16.Hemodialysis, Hemodiafiltration and Hemodialysis Safety-specific requirements for filtering equipment GB/T 13074-2009 Terms for blood purification YY0645-2018 Continuous blood purification equipment 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 Terminology

3.1 Dehydration amount fluidremoval The total output (filtrate) and the total input (the difference between the replacement fluid and the dialysate) of the device in a given time. and). 3.2 dehydration rate fluidremovalrate The dehydration volume of the device per hour. 3.3 fluid balance error fluidbalancingerror When the dehydration rate is set to 0mL/h, the difference between the actual total liquid output and the total liquid input in a given time of the device.

4 Overview

The continuous blood purification device (hereinafter referred to as the purification device) is a device that can lead the patient's blood from the body to the extracorporeal circulation system. In the system, through the input of a large amount of replacement fluid from outside the body, the harmful substances and excess water in the patient's body are continuously removed. A set of extracorporeal circulation devices that are connected and quickly cleared. Mainly composed of blood pump, replacement pump, anticoagulation pump, volume control system, safety It consists of a complete monitoring system and an alarm system. The main treatment modalities of the purification device include. VHDF);
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