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Detailed description

Hemodialysis device analysis

Detection standard

  • Detection specification

Where can I go to get a complete solution for hemodialysis device analysis? BAIJIAN Materials Testing Agency provides hemodialysis device analysis services. It is a national high-tech enterprise, a third-party materials laboratory, and a CMA qualification certification agency. It is a collectively owned scientific research institution with complete laboratory instruments. , a strong scientific research team, adhering to the concept of scientific research and dedication, engaged in performance testing, non-standard testing, unknown substance detection and identification, industrial problem diagnosis and testing, composition testing, failure testing, corrosion testing, etc. Test reports will be issued in 7-15 working days to support The QR code system checks authenticity, and multiple laboratory branches across the country support nationwide door-to-door sampling/sample delivery testing services.

Analysis cycle: 7-15 working days

Analysis fee: Initial inspection of samples. After the initial inspection, quotations will be made based on the customer's testing needs and the complexity of the experiment.

Hemodialysis device analysis scope

Hemodialysis filtration device, hemodialysis device consumables, hemodialysis blood collection needle device, hemodialysis thermal restraint device, hemodialysis pipeline fixation device, biological Hemodialysis equipment, hemodialysis pipeline equipment, etc.

Hemodialysis device analysis project

Safety requirements: voltage and current limits, enclosure protection level, insulation protection impedance, continuous leakage current, mechanical strength, stability, mobility, splash Objects, vibration noise, pneumatic and hydraulic power, X-ray radiation, microwave radiation, optical radiation, infrared radiation, ultraviolet radiation, ultrasonic waves, electromagnetic compatibility EMC, electrostatic charge, conductivity, transmembrane pressure, etc.

Certificate testing: testing whether the dialyzer meets national and industry standards.

Leak test: Check whether the dialyzer is leaking to ensure patient safety.

Filtration performance test: Test the filtration effect of the dialyzer to ensure blood purity.

Pressure test: Test whether the dialyzer works properly under pressure to ensure the durability of the dialyzer.

Flushing test: Test the washing effect of the dialyzer to ensure that no harmful substances will remain after the dialyzer is washed.

Storage condition testing: Test the performance and validity period of the dialyzer under storage conditions to ensure that the dialyzer will not be damaged under storage conditions.

Cleaning test: Test the residual substances after cleaning of the dialyzer to ensure that the cleaning effect of the dialyzer is good.

Retention test: Test that no harmful substances can be retained in the dialyzer to ensure patient safety.

Disassembly and assembly force test: Test the disassembly and assembly strength of the dialyzer to ensure ease of use.

Reverse osmosis membrane pore size test: Test the pore size of the reverse osmosis membrane to ensure the filtration effect of the dialyzer.

What does the BAIJIAN analysis report do? What problems can it help you solve?

1. Sales report. (Sales need to provide third-party testing reports to ensure that their products More personalized, let the product data speak for itself, allowing customers to trust their product quality more.)

2. R&D report. (In the process of developing new products, we encountered some thorny issues about ingredients. Through the Use third-party testing data to find the cause of the problem, solve the problem in a timely manner, shorten the R&D cycle, and reduce R&D costs)

3. Improve product quality. (Discover problems with your own products through comparison of third-party testing data, improve products problems, improve quality, and reduce production costs)

4. Use of scientific research paper data.

Hemodialysis device analysis standards

GB 9706.2-1991 Medical electrical equipment for blood Special safety requirements for dialysis devices

CNCA 08C-033-2001 Implementation Rules for Compulsory Certification of Medical Device Products. Hemodialysis Devices

HD 395.2.16 S1-1989 Medical Electrical Equipment. No. Part 2: Special requirements for the safety of hemodialysis devices

YY 0267-2016 Extracorporeal circulation blood circuit of blood purification devices for hemodialysis and related treatments

IEC PAS 63023:2016 Medical electrical systems. External Input interfaces for hemodialysis equipment for alarm devices

GOST R 50267.16-2003 Medical electrical equipment. Part 2: Special requirements for the safety of hemodialysis, hemodiafiltration and hemofiltration equipment

BS PD IEC/PAS 63023:2016 Medical electrical systems. Input interfaces for hemodialysis equipment for use with external alarm devices

ONORM EN 1283-1996 Hemodialyzer; hemodialysis filter; blood filter ;Hemoconcentrators and their extracorporeal circulation devices

YY 0053-2016 Hemodialyzers, hemodialysis filters, hemofilters and hemoconcentrators for hemodialysis and related treatments

GB/T 13074-1991 Blood purification terminology hemodialysis and hemofiltration

YY 0054-2003 Hemodialysis, hemodiafiltration and hemofiltration equipment

BAIJIAN Materials Testing Laboratory What are the advantages?

1. Collectively owned testing institutions with complete qualifications and scientific, fair and accurate test reports.

2. Multiple laboratory branches spread across the country, supporting door-to-door sampling/ Send samples for testing.

3. The testing cycle is short, the testing cost is low, and the experimental plan is more complete.

4. Initial testing samples, no testing fees will be charged during the initial testing period.


5. InspectionTest report supports scanning the QR code to check the authenticity.

BAIJIAN testing process

1. Send samples. (Communicate with engineers, submit your own testing requirements and send samples to our research institute)

2. Initial inspection samples. (After receiving the sample, conduct a preliminary inspection of the sample and formulate a detailed experimental plan)

3. Quotation. (After the initial inspection, a quotation will be made based on the customer's testing needs and the complexity of the experiment)

4. Both parties confirm, sign a confidentiality agreement, and start the experiment.

5. It takes 7-15 working days to complete the experiment.

6. Mail the test report and provide post-service.

The above is the relevant introduction to the analysis of hemodialysis equipment. If you have other needs, you can consult the laboratory engineer to help you solve it.

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