Where do biological evaluations go? Biological evaluation should not only evaluate the materials used in the device、 but also evaluate any extractable residues introduced or generated due to material synthesis processes、 device production processes、 device degradation processes、 etc. BAIJIAN can conduct biological evaluations on various materials、 etc Detection scope

Medical devices、 food grade materials、 stainless steel、 cosmetics、 creams、 plastics、 various packaging、 etc Biological evaluation includes cytotoxicity testing. Cytotoxicity testing is the use of in vitro cell culture methods to evaluate the potential for acute cytotoxicity in medical devices or their leachable components Stimulus tests include skin irritation tests、 eye irritation tests、 oral mucosal irritation tests、 and intradermal irritation tests Skin irritation test: The medical device or medical device extract is exposed to intact skin for a specified period of time to evaluate the irritating effect of the medical device on the local skin Eye irritation test

By dropping a certain amount of medical device or medical device extract into the eyes of animals、 observe the reactions of the cornea、 iris、 and conjunctiva、 and evaluate whether the medical device produces eye irritation Oral mucosal irritation test

Detects the stimulating effect of medical devices on oral mucosa The systemic acute toxicity test is a non-specific toxicity test. Inject the experimental material or material extract into the animal's body through intravenous or intraperitoneal injection、 observe its biological reactions、 and determine the acute toxicity of the material. When medical devices release components in a certain concentration in the body、 it may lead to systemic toxicity Hemolysis test is an in vitro test conducted using medical devices or their extracts to determine the degree of red blood cell lysis and hemoglobin dissociation、 and to evaluate the in vitro hemolysis of medical devices. As this test can sensitively reflect the impact of the sample on red blood cells、 it is a particularly meaningful screening test There are two main types of pyrogen tests、 namely the rabbit method and the bacterial endotoxin test method The rabbit method is a method of injecting a certain amount of experimental material extract into the rabbit's body through a vein、 and observing the changes in the rabbit's body temperature within a specified time to determine that the content of the extract meets the requirements of human application The bacterial endotoxins test method is a method that uses the mechanism of agglutination reaction between limulus reagent and bacterial endotoxins to determine whether the limit of bacterial endotoxins in biological materials and medical devices meets the regulations. The amount of endotoxins is expressed in units of toxin [EU] Genotoxicity、 Carcinogenicity、 and Reproductive Toxicity Tests

Genotoxicity、 Carcinogenicity、 and Reproductive Toxicity Tests According to the requirements of ISO for the biological evaluation of medical devices、 if medical devices come into long-term contact with the human body or are implanted in tissues or blood、 potential genetic toxicity、 carcinogenicity、 and reproductive toxicity biological evaluation tests should be conducted according to the following requirements. When medical devices are used for the following purposes、 genetic toxicity tests should be conducted: for mucous membranes or damaged skin surfaces with contact time exceeding 30 days; Used for indirect contact with blood for more than 30 days; Used to introduce into the body and have contact with tissues、 bones、 and blood for more than 24 hours; Used for implantation in the body、 in contact with tissues、 bones、 and blood for more than 24 hours Testing standards

6GB/T 156 0190 2607.4-2003 Biological evaluation of medical devices Part 4: Selection of interaction test with blood

7GB/T 156 0190 2607.5-2017 Biological evaluation of medical devices Part 5: In vitro cytotoxicity test

8GB/T 156 0190 2607.6-2015 Biological evaluation of medical devices Part 6: Local reaction test after implantation

9GB/T 156 0190 2607.7-2015 Biological evaluation of medical devices Part 7: Residual levels of ethylene oxide sterilization

10GB/T 156 0190 2607.9-2017 Biological evaluation of medical devices - Part 9: Qualitative and quantitative framework for potential degradation products

1. Does it comply with relevant regulations and standard requirements? If the evaluation is conducted according to the evaluation flowchart in GB/T156 0190 2607.1

2. Is the biological evaluation project selected according to the expected way and time of contact with the human body 3. Does the material characterization include the constituent materials and extracts? Does it cover all chemical substances released from the device? Does it include necessary quantitative testing data Is the material characterization sufficient、 is it targeted towards the target chemical、 and is the detection method sensitive 5. Is the toxicological data sufficient to cover each potentially toxic chemical substance in the extract 6. Is the principle of toxicological equivalence followed when comparing with commercially available products

7. For products with existing clinical evaluation data、 are clinical related data fully utilized in biological evaluation data to improve evaluation quality

8. Does the biological evaluation report summarize all data and experimental results?

1. Telephone consultation

2. Mailing biological evaluation samples or on-site sampling 3. Engineer quotation

4. Pay for testing fees and conduct experiments 5. Complete the experiment and issue a testing report 6. Mailing inspection reports and after-sales service

BAIJIAN Platform Service Quality Commitment Behavior Fairness: Consciously abide by the fairness statement. Method science: Following the principle of seeking truth from science and strictly following the prescribed methods for calibration work. Result: The certificate is standardized and rigorous、 and the data is reliable. Job: Continuously improve business processes based on actual situations and customer needs、 ensuring that calibration work is completed within the promised time. Reasonable charging: The calibration fee shall not exceed the charging standards approved by the national、 provincial、 and municipal price departments、 and shall not exceed the average level of peers. Customer satisfaction: Proactively understanding customer needs、 providing services、 timely accepting and handling customer complaints、 providing fast and convenient follow-up services. Baijiantest.com is a professional third-party material testing agency with various material testing needs and details. Free consultation with online consultants: 400-101-7153、 conducting testing on Baijiantest.com. Issuing authoritative testing reports has legal effect

Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

inspection and testing process:

1. Telephone communication and confirmation of requirements

Testing and testing characteristics:

1. The testing industry is fully covered、 meeting different testing needs

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing、 with no testing fees charged

5. Self service order delivery for free on-site sampling