EMC China Lab

Biological Safety Evaluation of Medical Devices

Views :
Update time : 2024-04-24

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.

 

Biological Safety Evaluation of Medical Devices(图1)


CHINA JJRLAB offers precise medical device testing services to its extensive clientele.

Email:hello@jjrlab.com

Biocompatibility Testing Items:

1. Bacterial Endotoxin Test

2. In Vitro Mammalian Chromosomal Aberration Test

3. Hemolysis Test

4. RED Blood Cell MICronucleus Test

5. Pyrogen Test

6. cytotoxicity 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


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
USA FDA Food Contact Material (FCM) Test Report USA FDA Food Contact Material (FCM) Test Report
01 .12.2026
FDA FCM testing ensures food-contact materials meet safety standards (CFR 21). JJR Lab provides ISO ...
FCM Food Contact Materials Certification FCM Food Contact Materials Certification
01 .12.2026
TEMU FCM Materials Testing by JJR Lab: EC1935/2004, covering migration, heavy metals, sensory & ...
SCC-Accredited CSA C22.2 No.42 Test Report Amazon SCC-Accredited CSA C22.2 No.42 Test Report Amazon
01 .12.2026
Amazon Canada requires CSA C22.2 No.42 USB test reports from SCC-accredited labs like JJR Lab to ens...
Compliance Tips for Button & Coin Cell Batteri Compliance Tips for Button & Coin Cell Batteri
01 .12.2026
Amazon US requires button/coin batteries to meet Reese Law child-resistant packaging and warning lab...
16 CFR 1243 & Nursing Pillow 16 CFR 1242/ASTM 16 CFR 1243 & Nursing Pillow 16 CFR 1242/ASTM
01 .12.2026
Amazon infant support & nursing pillows must meet 16 CFR 1243/1242 & ASTM F3669-24. JJR Lab ...
Two Approaches to Amazon Toy TIC Audit Two Approaches to Amazon Toy TIC Audit
01 .12.2026
Amazon enforces Toy TIC Direct Validation via two methods: TIC testing or lab verification by approv...
TIC Direct Validation for Power Banks and Lithium TIC Direct Validation for Power Banks and Lithium
01 .12.2026
Amazon mandates TIC Direct Validation for power banks; sellers must pass UL2056, IEC62368-1, UN38.3 ...
European Authorized Representative for Medical Dev European Authorized Representative for Medical Dev
01 .11.2026
JJR provides EU Authorized Representative service for medical devices, ensuring MDR compliance, ISO ...

Leave Your Message