EMC China Lab

Biocompatibility Testing for Medical Devices ISO 10993

Views :
Update time : 2024-04-15

The biocompatibility testing fee for ISO 10993 medical devices is $4,000, with a turnaround time of 4 weeks (including cytotoxicity testing, sensitization testing, and skin irritation testing). Our laboratory holds CNAS and CMA qualifications and is an GLP authorized laboratory, capable of providing you with biocompatibility testing reports in both Chinese and English.

Email: chen18814186731@gmail.com

Biocompatibility Testing for Medical Devices ISO 10993(图1)

What is Biocompatibility Testing?

Biocompatibility testing sounds highly specialized and might not draw much attention in daily life, but it's actually a mandatory testing process for all medical devices that come into direct contact with consumers/patients.


Biocompatibility refers to the compatibility between living tissues (human or animal) and inert materials (medical products), involving biological, physical, and chemical reactions. It generally refers to the compatibility between materials and hosts or, in simpler terms, the degree to which medical product materials can interact with or be implanted into the body without causing harm and to what extent.

Biocompatibility Testing for Medical Devices ISO 10993(图2)

Common Biocompatibility Tests

1. Cytotoxicity Test: Part 5 of the Biological Evaluation of Medical Devices – ISO 10993-5:1999. This test, conducted in vitro, simulates the growth environment of organisms outside the body to detect cytotoxic effects, inhibition of cell growth, and other toxic effects that occur when medical devices and biomaterials come into contact with body tissues.

2. Skin Irritation Test: Part 10 of the Biological Evaluation of Medical Devices – iso 10993-10:2002. This test evaluates the potential release of chemical substances from medical devices that may cause skin, mucous membrane, or eye irritation reactions when in contact with the human body.

3. Sensitization Test: Part 10 of the Biological Evaluation of Medical Devices – ISO 10993-10:2002. This test assesses immune system reactions caused by repeated or prolonged exposure to chemical substances.

Email:chen18814186731@gmail.com


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
Air Cooler CE Certification Testing Air Cooler CE Certification Testing
03 .31.2025
Air coolers require CE certification for Europe. Testing by China JJR Laboratory ensures compliance ...
Electric Hammer CE Certification Testing Electric Hammer CE Certification Testing
03 .31.2025
Electric hammer CE certification testing by China JJR Laboratory ensures compliance with EU standard...
Hair Clipper CE Certification Testing Hair Clipper CE Certification Testing
03 .31.2025
Hair clippers require CE certification for Europe, complying with Low Voltage 2014/35/EU, EMC 2014/3...
Ultrasonic Fishing Machine CE Certification Test Ultrasonic Fishing Machine CE Certification Test
03 .31.2025
The ultrasonic fishing machine, CE certified, follows EU directives and standards. Testing is provid...
Power Adapter Certifications for Thailand Power Adapter Certifications for Thailand
03 .31.2025
Power adapters exported to Thailand require TISI certification. China JJR Laboratory offers testing ...
US Clothing GCC Certificate 16CFR 1610 Standard Te US Clothing GCC Certificate 16CFR 1610 Standard Te
03 .31.2025
US Clothing GCC Certificate 16CFR 1610 flammability test ensures compliance with US safety standards...
US Fire Mask ASTM E2952-23 Standard Test US Fire Mask ASTM E2952-23 Standard Test
03 .31.2025
The Fire Mask ASTM E2952-23 standard tests air-purifying smoke protection devices, ensuring 15 minut...
Teething Toy CPC Certification ASTM F963-23 Testin Teething Toy CPC Certification ASTM F963-23 Testin
03 .31.2025
JJR Lab offers ASTM F963-23 testing for teething toys, covering updates on heavy metals, phthalates,...

Leave Your Message