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JJF 1693-2018 English PDF

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JJF 1693-2018: Calibration Specification for Intracranial Pressure Monitors
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Basic data

Standard ID JJF 1693-2018 (JJF1693-2018)
Description (Translated English) Calibration Specification for Intracranial Pressure Monitors
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Word Count Estimation 18,124
Date of Issue 2018-02-27
Date of Implementation 2018-05-27
Regulation (derived from) AQSIQ Announcement No. 26 of 2018
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine

JJF 1693-2018: Calibration Specification for Intracranial Pressure Monitors

---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.
(Intracranial pressure monitor calibration specification) National Metrology Technical Specification of the People's Republic Intracranial pressure monitor calibration specification Published on.2018-02-27 2018-05-27 implementation The General Administration of Quality Supervision, Inspection and Quarantine issued Intracranial pressure monitor calibration specification Focal Point. National Medical Metrology Technical Committee Main drafting unit. China Testing Technology Research Institute Wuxi Metrology and Testing Institute Xinjiang Uygur Autonomous Region Metrology and Testing Institute Participated in drafting unit. Wuxi Haiying Electronic Medical System Co., Ltd. This Code entrusts the National Medical Metrology Technical Committee to explain The main drafters of this specification. Zhang Conghua (China Testing Technology Research Institute) Shi Min (Wuxi Metrology and Testing Institute) Li Feng (Xinjiang Uygur Autonomous Region Metrology and Testing Institute) Participate in the drafters. Yan Haidong (Wuxi Metrology and Testing Institute) Wang Guanxi (Wuxi Metrology and Testing Institute) Liu Cao (China Testing Technology Research Institute) Zhou Xiaobo (Wuxi Haiying Electronic Medical System Co., Ltd.)

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 terms and units of measurement (1) 4 Overview (1) 5 Measurement characteristics (1) 5.1 intracranial pressure measurement range (1) 5.2 intracranial pressure zero error (1) 5.3 Intracranial pressure indication error (1) 5.4 Intracranial pressure alarm indication error (2) 5.5 Temperature range (2) 5.6 Temperature resolution (2) 5.7 Temperature indication error (2) 6 Calibration conditions (2) 6.1 Environmental conditions (2) 6.2 Measurement standards and other equipment (2) 7 Calibration items and calibration methods (3) 7.1 Appearance and Functional Inspection (3) 7.2 Intracranial pressure measurement range (3) 7.3 Intracranial pressure zero error (3) 7.4 Intracranial pressure indication error (3) 7.5 Intracranial pressure alarm indication error (3) 7.6 Temperature indication error (4) 8 calibration result expression (4) 9 re-study interval (4) Appendix A Cranial Pressure Monitor Calibration Original Record (Recommended) Format (5) Appendix B Calibration Certificate Inner Page (Recommended) Format (7) Appendix C Example of Uncertainty Evaluation of Pressure Indication Error Measurement Results (8) Appendix D Example of Uncertainty Evaluation of Temperature Indication Error Measurement Results (10)

Introduction

This specification is based on JJF 1001-2011 "General Terms and Definitions of Measurement", JJF 1059.1-2012 The determination and representation of certainty, JJF 1071-2010, the preparation of the National Metrology Calibration Specification. For the actual situation of the intracranial pressure monitor, the development of this calibration specification refers to JJG875-2005 "Digital Pressure" And "JJF 1226-2009" Medical Electron Thermometer Calibration Specification. This specification is the first release. Intracranial pressure monitor calibration specification

1 Scope

This specification is applicable to the school with an invasive intracranial pressure monitor and a multi-parameter monitor with an invasive intracranial pressure monitoring function. Standard, not applicable to the calibration of non-invasive intracranial pressure monitors.

2 reference files

This specification refers to the following documents. JJG875 digital pressure gauge JJF 1226 Medical Electronic Thermometer Calibration Specification 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 Terminology 3.1.1 intracranial pressure intracranialpressure The pressure generated by the contents of the cranial cavity on the cranial wall is also called brain pressure. 3.1.2 Probe pressuredetector A sensor that senses intracranial pressure and transmits the signal to an intracranial pressure monitor. 3.2 Unit of measurement 3.2.1 Name of intracranial pressure unit. kilopascal; symbol. kPa. 3.2.2 Name of temperature unit. Celsius; symbol. °C.

4 Overview

The intracranial pressure monitor (hereinafter referred to as the monitor) is a medical instrument for continuously measuring the intracranial pressure of a human body. For the invasive intracranial pressure monitor and non-invasive intracranial pressure monitor. The principle of an invasive monitor is to apply a pressure sensitive probe or pressure The force transmission mechanism is placed in the epidural, subdural, intraventricular and other parts of the brain, and the intracranial pressure is sensed in real time, and will be sensed. The pressure signal is transmitted to the monitoring unit for data processing, and the intracranial pressure is calculated and displayed. The monitor is mainly composed of a probe, A signal processing unit, a data display terminal, and the like.

5 Measurement characteristics

5.1 intracranial pressure measurement range Measuring range. (-5~20) kPa. 5.2 intracranial pressure zero error Zero error. ± 0.1 kPa. 5.3 intracranial pressure indication error

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