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JJF 1633-2017 English PDF

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JJF 1633-2017: Calibration Specification for Hemoperfusion Equipment
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JJF 1633-2017459 Add to Cart 4 days Calibration Specification for Hemoperfusion Equipment Valid

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Basic data

Standard ID: JJF 1633-2017 (JJF1633-2017)
Description (Translated English): Calibration Specification for Hemoperfusion Equipment
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A53
Word Count Estimation: 20,214
Date of Issue: 2017-09-26
Date of Implementation: 2017-12-26
Regulation (derived from): General Administration of State Quality Inspection Announcement 2017 No. 78
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine

JJF 1633-2017: Calibration Specification for Hemoperfusion Equipment

---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 of blood perfusion devices) People's Republic of China National Measurement Specifications Hemoperfusion device calibration specification CalibrationSpecification forHemoperfusionEquipment 2017-09-26 Posted 2017-12-26 Implementation General Administration of Quality Supervision, Inspection and Quarantine released Hemoperfusion device calibration specification The focal point. National Medical Measurement Technical Committee Drafting unit. Guangzhou Institute of Measurement and Testing Technology Shanxi Institute of Metrology This specification entrusts the National Medical Metrology Technical Committee responsible for the interpretation The main drafters of this specification. Hu Liangyong (Guangzhou Institute of Measurement and Testing Technology) Zheng Chunxiong (Guangzhou Institute of Measurement and Testing Technology) Fan Wang (Shanxi Institute of Metrology) Participate in the drafters. Zhang Junbin (Shanxi Institute of Metrology) Shijin Ping (Shanxi Institute of Metrology)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Terms and measurement units (1) 3.1 Terms (1) 3.2 Unit of Measure (2) 4 Overview (2) 5 Metrology (2) 6 Calibration conditions (2) 6.1 Environmental conditions (2) 6.2 Calibration media (2) 6.3 Measurement standards and other equipment (3) 7 Calibration Items and Calibration Methods (3) 7.1 appearance and normal work inspection (3) 7.2 alarm function and security system inspection (3) 7.3 Preparing for calibration (4) 7.4 Blood flow (4) 7.5 anticoagulation pump injection flow (4) 7.6 Blood temperature (4) 7.7 Static (arterial) pulse pressure (5) 7.8 Alarm signal sound (5) 8 Calibration Results Expression (5) 8.1 Calibration records (5) 8.2 Calibration Results Processing (5) 9 time interval of correction (6) Appendix A Hemoperfusion Device Calibration Original Records (Recommended) Format (7) Appendix B Hemoperfusion Device Calibration Certificate Internal Page (Recommended) Format (10) Appendix C Measurement Uncertainty Evaluation Example (12)

Introduction

This specification is based on JJF 1001-2011 "common measurement terms and definitions", JJF 1059.1-2012 "measurement is not Determination of certainty and said ", JJF 1071-2010" National Metrology Calibration Rules Compilation Rules "preparation. This specification made reference to the YY0790-2010 "hemoperfusion equipment." This specification is first released. Hemoperfusion device calibration specification

1 Scope

This calibration specification specifies the measurement characteristics of hemoperfusion devices, calibration conditions, calibration methods, apply to the new system Calibration of metrological performance of hemoperfusion devices manufactured, in use and after repair.

2 reference documents

This specification cites the following documents. Laboratory use specifications and test methods for analysis GB/T 6682-2008 GB 9706.2-2003 medical electrical equipment 2-16 part hemodialysis, hemodiafiltration and hemofiltration Special requirements for the safety of the equipment Blood purification terminology GB/T 13074-2009 YY0790-2010 Hemoperfusion 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 Terms and measurement units

3.1 Terms 3.1.1 Hemoperfution of hemoperfusion Lead the patient's blood out of the body, through the adsorption of the cartridge to remove exogenous and endogenous toxicants in the blood A method of blood purification. 3.1.2 hemoperfutor hemoperfutor Equipped with activated carbon or resin adsorbents, devices for blood purification treatment. 3.1.3 bloodflowrate The amount of extracorporeal circulation of blood per unit time. 3.1.4 Venous pressure venouspressure The pressure measured on the extracorporeal tubing from the outlet of the cartridge to the entrance to the blood return. 3.1.5 pump before arterial pressure prepumparterialpressure Human to blood pressure between the pump. 3.1.6 post-pump arterial pressure postpumparterialpressure Blood pressure between pump and cartridge. 3.1.7 blood purification bloodpurification Through the removal of harmful substances in the blood to achieve the treatment of certain diseases, including hemodialysis, hemofiltration Over, hemodiafiltration, peritoneal dialysis, hemoperfusion and plasma conversion. 3.1.8 anticoagulant pump heparinpump The pump that injects anticoagulant into the blood pipeline can be quantitatively and quantitatively.
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