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JJF 1353-2024 English PDF

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Q: Should I purchase the latest version JJF 1353-2024?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version JJF 1353-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$559.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
JJF 1353-2024: Calibration Specification for Haemodialysis Equipment
Status: Valid

JJF 1353: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1353-2024	559	Add to Cart	5 days	Calibration Specification for Haemodialysis Equipment	Valid
JJF 1353-2012	529	Add to Cart	4 days	Calibration Specification for Hemodialysis Equipment	Valid
JJF 1353-1990	199	Add to Cart	2 days	O.T.N. for Primary Standard of Combustion Energy	Obsolete

Basic data

Standard ID: JJF 1353-2024 (JJF1353-2024)
Description (Translated English): Calibration Specification for Haemodialysis Equipment
Sector / Industry: Metrology & Measurement Industry Standard
Word Count Estimation: 27,212
Date of Issue: 2024-09-18
Date of Implementation: 2025-03-18
Issuing agency(ies): State Administration for Market Regulation

JJF 1353-2024: Calibration Specification for Haemodialysis 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.
National Metrology Technical Specifications of the People's Republic of China Specification for calibration of hemodialysis equipment Released on 2024-09-18 2025-03-18 Implementation The State Administration for Market Regulation issued Specification for calibration of hemodialysis equipment Replace JJF 1353-2012 Responsible unit. National Medical Metrology Technical Committee Main drafting unit. Guangzhou Institute of Metrology and Testing Technology China National Institute of Metrology Participating in the drafting. Guangzhou Women and Children's Medical Center The First Affiliated Hospital of Guangzhou Medical University This standard is entrusted to the National Medical Metrology Technical Committee for interpretation The main drafters of this specification are. Zheng Chunxiong (Guangzhou Institute of Metrology and Testing Technology) Hu Liangyong (Guangzhou Institute of Metrology and Testing Technology) Sun Jie (China National Institute of Metrology) Participating drafters. Wu Jie (Guangzhou Institute of Metrology and Testing Technology) Ma Xueran (China National Institute of Metrology) Xie Weihua (Guangzhou Women and Children's Medical Center) Tan Zhijian (The First Affiliated Hospital of Guangzhou Medical University)

Introduction (II) 1 Scope(1) 2 References(1) 3 Terminology and units of measurement (1) 4 Overview(2) 5 Metering characteristics (2) 6 Calibration conditions(3) 6.1 Environmental conditions(3) 6.2 Measurement standards and other equipment (3) 7 Calibration items and calibration methods (4) 7.1 Appearance and working order inspection (4) 7.2 Relative error of the indicated value of the conductivity of the dialysate (4) 7.3 Dialysis fluid temperature indication error (4) 7.4 Static (dynamic) pulse pressure indication error (4) 7.5 Relative error of dialysate flow indication (4) 7.6 Relative error of the anticoagulant pump injection flow setting value (5) 7.7 Dehydration setting value error (5) 7.8 Relative error of blood flow setting value (5) 8 Expression of calibration results (6) 8.1 Calibration records(6) 8.2 Processing of calibration results (6) 9 Recalibration interval (6) Appendix A Hemodialysis Equipment Calibration Record (Recommended) Format (7) Appendix B Hemodialysis Equipment Calibration Certificate Inner Page (Recommended) Format (10) Appendix C Example of measurement uncertainty assessment of relative error of dialysate flow indication (12) Appendix D Example of measurement uncertainty assessment for relative error of conductivity indication (14) Appendix E Example of evaluation of measurement uncertainty of temperature indication error (16) Appendix F Example of evaluation of measurement uncertainty of pressure indication error (18) Appendix G Example of uncertainty assessment of relative error of anticoagulant pump injection flow setting value (20)

Introduction

JJF 1071 "Rules for the Preparation of National Metrology and Calibration Specifications", JJF 1001 "General Metrology Terms and Definitions", JJF 1059.1 "Evaluation and Expression of Uncertainty in Measurement" together constitute the basic series supporting the revision of this specification document. Compared with JJF 1353-2012 "Hemodialysis Equipment Calibration Specification", this specification has the following main changes, except for editorial changes. The technical changes are as follows. --- Added the introduction; ---Detailed the scope of content; ---According to the modification of calibration items and calibration methods, the terminology, measurement standards and other equipment were modified accordingly. Adjustment; --- Modified the measurement characteristics requirements of "dialysis fluid flow" and "dehydration amount"; --- Modified the technical requirements for measurement standards and other equipment; --- Deleted "dialysis fluid pressure", "weighing meter", "dialysis fluid pH", "housing leakage current" and alarm functions Calibration items; --- Added "blood flow" calibration item; --- Deleted the indirect measurement methods of "dialysis fluid flow" and "anticoagulant pump infusion flow"; ---Improved the calibration methods of "dialysis fluid temperature" and "dehydration amount". The previous versions of this specification are as follows. ---JJF 1353-2012. Specification for calibration of hemodialysis equipment

1 Scope

This specification applies to the calibration of automatic liquid preparation hemodialysis devices. This standard does not apply to peritoneal dialysis devices, hemoperfusion, blood exchange, plasma adsorption devices, continuous blood Calibration of the purification unit.

2 References

This specification references the following documents. GB 9706.2-2003 Medical electrical equipment Part 2-16.Hemodialysis, hemodiafiltration and blood Particular requirements for the safety of filtration equipment GB 13074-2009 Terminology of blood purification YY0054-2010 Hemodialysis Equipment For any referenced document with a date, only the version with the date is applicable to this specification; for any referenced document without a date, The latest version (including all amendments) shall apply to this specification.

3 Terminology and units of measurement

3.1 Terminology The terms and definitions defined in GB/T 13074-2009 and the following apply to this specification. 3.1.1 Dialysis Solutes diffuse through the semipermeable membrane. [Source. GB/T 13074-2009, 2.1.2] 3.1.2 Hemodialysis (HD) The blood is drawn out of the body and the solute imbalance in the patient's blood is corrected through the diffusion effect of the dialyzer semipermeable membrane. method. [Source. GB/T 13074-2009, 2.1.1] 3.1.3 Dialysate During hemodialysis, a solution exchanges solutes with blood across a semipermeable membrane. [Source. GB/T 13074-2009, 2.1.5] 3.1.4 Hemodialyzer A device consisting of a semipermeable membrane and a supporting structure. [Source. GB/T 13074-2009, 2.1.10] 3.1.5 Conductivity The conductivity of the dialysate is used to indirectly reflect the concentration of dialysate electrolytes. [Source. GB/T 13074-2009, 2.5.19] ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of JJF 1353-2024_English be delivered?

Answer: Upon your order, we will start to translate JJF 1353-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of JJF 1353-2024_English with my colleagues?

Answer: Yes. The purchased PDF of JJF 1353-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version JJF 1353-2024?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version JJF 1353-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.