EMC China Lab

Where to get biocompatibility tested?

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Update time : 2024-04-23

One of the most basic contents of biocompatibility testing/evaluation is biosafety.


Biosafety means that materials must be non-toxic, non-allergenic, non-irritating, non-genotoxic, non-carcinogenic, and have no adverse reactions to human tissues, blood, and immune systems under the interaction between materials and the human body.


JJRLAB medical and biological laboratory has obtained China CMA and American IAS qualification certificates. At the same time, the laboratory operates in strict accordance with the GLP system. It is a laboratory recognized by government regulatory agencies such as the US FDA/Australia TGA/Brazil ANVISA, and is also a laboratory recognized by the US UL and the Canadian CSA. , TUV in Germany, SGS in Switzerland, Intertek in the UK, BSI in the UK, MEDCERT in Germany, IMQ in Italy and many other recognized laboratories and partners.

Where to get biocompatibility tested?(图1)

JJRLAB laboratory provides you with the most professional, efficient and comprehensive biocompatibility evaluation and biocompatibility test report services.


Test items

Reference standard

Testing cycle (weeks)

Biocompatibility testing



cytotoxicity test

Cytotoxicity test (MTT method)

ISO 10993-5/USP 87/GB/T 16886.5/ISO 7405/YY 0127.9/GB/T 14233.2

2 weeks

Cytotoxicity test (agar method)

2 weeks

Cytotoxicity test (filter membrane method)

2 weeks

Cytotoxicity test (direct contact method)

2 weeks

Cytotoxicity test (elution method)

2 weeks

Irritation and sensitization testing

Sensitization test (maximum dose method/patch method)

iso 10993-10/ GB/T 16886.10/ GB/T 14233.2

6~8 weeks

skin irritation test

ISO 10993-10/GB/T 16886.10

2 weeks

intradermal irritation

ISO 10993-10/GB/T 16886.10/USP 88/GB/T 14233.2

2 weeks

Oral irritation (histopathological reading required)

ISO 10993-10/GB/T 16886.10

6-8 weeks

Vaginal irritation (histopathological reading required)

6-8 weeks

Penile stimulation (histopathology reading required)

6-8 weeks

Rectal irritation (histopathological reading required)

6-8 weeks

Eye irritation

4 weeks

Systemic systemic toxicity test

Acute systemic toxicity test (intravenous/oral)

ISO 10993-11/ GB/T 16886.11/ USP88/ GB/T 14233.2

2 weeks

Subacute systemic toxicity test (14 days/28 days) (without histopathological reading)

ISO 10993-11/ GB/T 16886.11/ GB/T 14233.2

4 weeks/6 weeks

Subacute systemic toxicity test (14 days/28 days) (with histopathological reading)

ISO 10993-11/ GB/T 16886.11/ GB/T 14233.2

6 weeks/6-8 weeks

Subchronic systemic toxicity test (90 days)

4-4.5 months

Chronic systemic toxicity test (180 days)

7.5-8 months

Pyrogen test

ISO 10993-11/ GB/T 16886.11/ Chinese Pharmacopoeia

2 weeks

implantation test

Subcutaneous implantation (requires histopathological reading) in rabbits and rats

ISO 10993-6/ GB/T 16886.6/ USP 88


Muscle implantation (histopathology reading required) rabbit, rat

ISO 10993-6/ GB/T 16886.6/ USP 88


Bone implantation (histopathological reading required) rabbit, rat 

ISO 10993-6/GB/T 16886.6


blood compatibility test

Hemolysis test (rabbit blood is preferred)

ISO 10993-4/ GB/T 16886.4/ GB/T 14233.2

2 weeks

Hemolysis test (rabbit blood is preferred)

ASTM F756 (need to be specified by customer)

4-6 weeks

coagulation

ISO 10993-4/GB/T 16886.4

4-6 weeks

platelet count

4-6 weeks

total complement

4-6 weeks

Thrombosis (in vivo (canine CTI), in vitro)

4-6 weeks

Genotoxicity test

Ames Salmonella Typhimurium Reverse Mutation Test

ISO 10993-3/GB/T 16886.3/YY/T 0127.10

6-8 weeks

Gene mutation

ISO 10993-3/ GB/T 16886.3/ OECD 476

6-8 weeks

Chromosome Aberration Test

ISO 10993-3/ GB/T 16886.3/ OECD 473

6-8 weeks

Sperm aberrations (animals, rats) require microscope reading

ISO 10993-3/GB/T 16886.3

6-8 weeks

Micronucleus test (animals, mice) requires microscope reading

ISO 10993-3/ GB/T 16886.3/ OECD 474

6-8 weeks

      

For more details on biocompatibility testing and biocompatibility evaluation, please contact China JJRLAB

Email:hello@jjrlab.com


Email:hello@jjrlab.com


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