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 >>
How to get the AS/NZS 4268:2017+A1:2021 Test Repor How to get the AS/NZS 4268:2017+A1:2021 Test Repor
12 .31.2025
Get the AS/NZS 4268:2017+A1:2021 Test Report from JJR Laboratory for RF compliance testing of short-...
KC Certification Process for South Korea KC Certification Process for South Korea
12 .31.2025
KC certification for Korea: follow KC60950-1, 60335-1, KC71 standards; JJR Laboratory provides testi...
USB Charger Australia AS/NZS CISPR 32 Testing USB Charger Australia AS/NZS CISPR 32 Testing
12 .31.2025
USB Charger Australia compliance: AS/NZS CISPR 32 EMC & RE testing plus AS/NZS 62368.1 safety. G...
How Much Does C-Tick Certification Cost for Electr How Much Does C-Tick Certification Cost for Electr
12 .31.2025
C-Tick cost varies; JJR Lab provides EMI/RF testing to AS/NZS CISPR 15/22/32/13; example RCM wired t...
What is AS/NZS CISPR 32 Compliance Certification? What is AS/NZS CISPR 32 Compliance Certification?
12 .31.2025
AS/NZS CISPR 32 defines EMC emission & immunity tests for multimedia devices. JJR Laboratory pro...
How to get the AS/NZS CISPR 32 Test Report? How to get the AS/NZS CISPR 32 Test Report?
12 .31.2025
Get AS/NZS CISPR 32 test report with JJR Laboratory: 2–3 weeks EMC & safety testing, meet RCM re...
SIRIM Certification for Battery Exports to Malaysi SIRIM Certification for Battery Exports to Malaysi
12 .30.2025
SIRIM Certification enables battery export to Malaysia under IEC/UN standards; JJR Lab provides test...
ANATEL Certification for Power Banks and Phone Bat ANATEL Certification for Power Banks and Phone Bat
12 .30.2025
ANATEL cert for power banks & phone batteries: tests per IEC 62133 & IEC 61960 standards. JJ...

Leave Your Message