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Detailed description

biological evaluation

Detection standard

  • Detection specification

Where to go for biological evaluation and testing? BAIJIAN Materials Testing Agency can provide biological evaluation services for CMA qualification certification institutions, high-tech enterprises, and third-party materials laboratories. Aiming at the problems encountered in product development and quality control, Provides comprehensive solutions for ingredient testing, product testing, product testing, instrument testing, etc., with complete instruments and a strong scientific research team. Test reports can be issued in 7-15 working days. Scanning QR codes are supported to check authenticity. Nationwide door-to-door sampling and sample testing services are provided. , short testing cycle, low testing cost, scientific and accurate testing data!

Testing cycle: 7-15 working days


Testing fee: Engineers will develop an experimental plan and quote based on the customer's testing needs and the complexity of the experiment.

Scope of biological evaluation

Medical devices, cosmetics, masks, oral materials, vaccines, infusion needles, sterile dressings, lactic acid, suction tubes, stainless steel, carbon fiber, food and drugs , plastic teeth, implants, condoms, endotracheal tubes, abs plastic, absorbable materials, magnetic materials, drainage catheters, medical infusion tubes, syringes, blood transfusion materials, medical silicone materials, etc.

Evaluation items

Biological assessment (Bioassay) refers to the use of biological materials such as the entire organism or its organs or cells to evaluate the biological activity or toxicity of a certain substance or drug. Common biological evaluation items are as follows:

Cell proliferation/apoptosis detection

Cell phagocytosis/endocytosis detection

Cell migration/invasion detection

Cell differentiation experiment

Cell morphology analysis experiment

Cell fusion experiment

Cell agglutination/dissociation experiment

Cell electrophysiology experiment

Cell membrane permeability test

Gene transfection experiment

Cell endocrine test

ATP test

Cell Breath test

Intracellular calcium ion concentration test

Red blood cell agglutination test

Immunoglobulin antigen detection test

Biological membrane ion channel detection Experiment

Cytotoxicity and immunotoxicity testing

Hemoglobin determination experiment

Enzyme activity detection experiment

What are the functions of the BAIJIAN report? Can it help? What problems do you solve?

1. Sales and use. (Sell your own products and issue third-party testing reports to make customers more confident in the quality of your products)

2. R&D and use. (During the research and development process, some difficult problems are encountered, and the problems are solved through test report data, thus shortening the research and development process.cycle, reduce R&D costs)

3. Improve product quality. (By comparing test data, we can discover the problems of our own products, improve product quality, and reduce production costs)

4. Use of scientific research paper data.

5. Bidding and bidding (BAIJIAN has a relatively short testing cycle, low testing costs, and high recognition, and is especially suitable for bidding)

Biological Evaluation Standards

GB/T 16175-2008 Test Methods for Biological Evaluation of Medical Silicone Materials

GB/T 16886.1-2011 Medical Device Biological Evaluation Biological Evaluation Part 1: Evaluation and Testing in the Risk Management Process

GB/T 16886.2-2011 Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements

GB/T 16886.3 -2019 Biological Evaluation of Medical Devices Part 3: Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests

GB/T 16886.4-2003 Biological Evaluation of Medical Devices Part 4: Test Selection for Interaction with Blood


GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In vitro cytotoxicity test

GB/T 16886.6-2015 Biological Evaluation of Medical Devices Part 6: Post-implantation local Reaction test

GB/T 16886.7-2015 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residue

GB/T 16886.9-2017 Biological Evaluation of Medical Devices Part 9: Qualitative and quantitative framework for potential degradation products

GB/T 16886.10-2017 Biological evaluation of medical devices Part 10: Irritation and skin sensitization testing

GB/T 16886.11-2011 Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Test

GB/T 16886.12-2017 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials

GB /T 16886.13-2017 Biological Evaluation of Medical Devices Part 13: Qualification and Quantification of Degradation Products of Polymer Medical Devices

GB/T 16886.14-2003 Biological Evaluation of Medical Devices Part 14: Determination of Ceramic Degradation Products Qualitative and Quantitative

GB/T 16886.15-2003 Biological Evaluation of Medical Devices Part 15: Qualitative and Quantitative of Metal and Alloy Degradation Products

GB/T 16886.16-2013 Biological Evaluation of Medical Devices Scientific Evaluation Part 16: Toxicokinetic Study Design of Degradation Products and Leachables

GB/T 16886.17-2005 Biological Evaluation of Medical Devices Part 17: Establishment of Allowable Limits of Leachable Matter

GB/T 16886.18-2011 Biological Evaluation of Medical Devices Part 18: Chemical Characterization of Materials


GB/T 16886.19-2011 Biological Evaluation of Medical Devices Part 19: Characterization of Physicochemical, Morphological and Surface Properties of Materials

GB/T 16886.20-2015 Biological Evaluation of Medical Devices Part 20 Part: Principles and methods of immunotoxicological testing of medical devices

What are the advantages of BAIJIAN testing? Why choose BAIJIAN?

1. BAIJIAN is a collectively owned testing institution.

2. Initial inspection samples.

3. Multiple laboratory branches across the country support door-to-door sampling/send sample testing.

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

5. Complete qualifications, complete laboratory equipment, and a strong scientific research team.

6. Support MSDS writing service in 36 languages

BAIJIAN sample sending and testing process

1. Sample sending

2. Initial inspection Sample

3. Quotation

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

5. Complete the experiment in 7-15 working days

6. Issue test reports and provide follow-up services.

The above is a relevant introduction to biological evaluation. If you have other needs, you can consult the laboratory engineer to help you answer them.

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