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JJF 1541-2015 English PDF

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JJF 1541-2015: Calibration Specification for Hemodialysis Equipment Tester
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Basic data

Standard ID JJF 1541-2015 (JJF1541-2015)
Description (Translated English) Calibration Specification for Hemodialysis Equipment Tester
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 18,125
Date of Issue 2015-08-24
Date of Implementation 2015-11-24
Regulation (derived from) AQSIQ Announcement 2015 No.106
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine

JJF 1541-2015: Calibration Specification for Hemodialysis Equipment Tester

---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.
(Hemodialysis apparatus detector calibration specification) People's Republic of China National Metrology Technical Specifications Hemodialysis apparatus detector calibration specification Issued on. 2015-08-24 2015-11-24 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Hemodialysis apparatus detector calibration specification Focal point. the National Technical Committee on Medical Measurement The main drafting units. China Institute of Metrology Participated in the drafting unit. Nanjing measurement supervision and detection hospital This specification entrusted to the National Technical Committee is responsible for interpreting medical measurement The main drafters of this specification. Pu Zhang (China Institute of Metrology) Sun Jie (China Institute of Metrology) Drafters participate. Li Jiao (China Institute of Metrology) Hu Ning (Nanjing Supervision and Testing Institute) Xu liter (Nanjing Supervision and Testing Institute) Liu Zhou (Nanjing Supervision and Testing Institute)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 terminology and units of measurement (1) Conductivity 3.1 (1) Flow rate 3.2 (1) 4 Overview (1) 5 Metrological characteristics (2) 5.1 Conductivity (2) 5.2 Temperature (2) 5.3 Pressure (2) 5.4 pH value (2) Flow 5.5 (2) Calibration Condition 6 (2) 6.1 environmental conditions (2) 6.2 standards and other measuring equipment (2) 7 Calibration methods and calibration items (3) 7.1 appearance and function check (3) Conductivity 7.2 (3) Temperature 7.3 (3) Pressure of 7.4 (3) 7.5 pH (4) Flow 7.6 (4) 8 calibration results expression (4) 8.1 Calibration original records (4) 8.2 Calibration process results (4) 9 Recalibration interval (5) Appendix A hemodialysis apparatus detector calibration original records (recommended) formatting styles (6) Appendix B calibration certificate within the page (recommended) formatting styles (8) Appendix C hemodialysis apparatus conductivity detector calibration results Evaluation of Uncertainty Example (10) Appendix D hemodialysis apparatus detector flow calibration results Evaluation of Uncertainty Example (12)

Introduction

Preparation of this specification to JJF 1071-2010 "National Calibration Specifications writing rules", GB/T 13074- 2009 "blood purification term", JJF 1353-2012 "hemodialysis apparatus calibration specification", JJF 1059.1-2012 "Evaluation and Expression of Uncertainty in Measurement" as the basis and foundation. This specification is the first release. Hemodialysis apparatus detector calibration specification

1 Scope

This standard applies to the hemodialysis device detector calibration. 2. References This specification references the following documents. JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement JJF 1353-2012 hemodialysis apparatus calibration specification GB/T 13074-2009 blood purification term For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.

3 terminology and units of measurement

3.1 Conductivity conductivity The reciprocal of resistivity is conductivity. In the middle conductivity hemodialysis dialysate to the dialysate indirectly reflect Electrolyte concentration, in units of mS/cm. 3.2 Traffic flow The unit of time the amount of fluid flowing through the pipe cross-section. Units of mL/min.

4 Overview

Detector hemodialysis apparatus (Figure 1) is mainly composed of host detector, conductivity sensor, temperature sensor , Pressure sensors, pH value sensor, a flow sensor of several parts. Hemodialysis device detector working original Li is the measurement of the parameters of each sensor corresponding to the access device hemodialysis tubing, electrical conductivity, temperature, pressure, pH, flow and other parameters were measured, the measurement results of each parameter measurements hemodialysis apparatus monitoring system Comparison, to achieve the purpose of calibration of the hemodialysis apparatus. Hemodialysis apparatus 1 a schematic diagram of the structure of the detector

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