There are many medical devices or components that come into direct or indirect contact with the human body in medical device products. During interaction with biological entities, these devices may induce a series of biological reactions or material responses that are incompatible with the intended application. The outcomes of these reactions may pose risks to the health of users or affect the proper functioning of medical devices. Therefore, prior to clinical application, medical devices require systematic biological evaluation.

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1. Bacterial Endotoxin Test
2. In Vitro Mammalian Chromosomal Aberration Test
3. Hemolysis Test
4. RED Blood Cell MICronucleus Test
5. Pyrogen Test
7. Acute Systemic Toxicity Test
8. Animal Irritation Test
9. Subacute Systemic Toxicity Test
10. Intracutaneous Irritation Test
11. Subchronic Systemic Toxicity Test
12. Skin Sensitization Test
13. Bacterial Reverse Mutation Test
14. Implantation Site Response Test
15. Bone Implantation Site Response Test
16. Muscle Implantation Site Response Test
17. Rectal Irritation Test
18. Vaginal Irritation Test
19. Penile Irritation Test
Lighting RCM Compliance Certification
Sports Camera Export to the EU CE Certification
FCC Part 15B vs 15C Certification for Electronic D
Differences Between EU REACH Testing and SVHC Test
How to Conduct REACH Testing for Exporting to the
Australia AS/NZS 4417.1 and AS/NZS 4417.2 Complian
Children’s Jewelry ASTM F2923-20 Compliance
LFGB Certification Test Items
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