EMC China Lab

Biocompatibility Testing of Biomaterials

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Update time : 2024-06-08

The Most Frequently Asked Question in 2023: How Much Does ISO 10993 biocompatibility testing cost?


For example, the cytotoxicity test costs $500 and takes 10 working days. The acute toxicity test costs $750, with a testing period of 15 days. There are over ten different biocompatibility tests in this series. I will list them below.


JJRLAB is an IEC 17025 and GLP accredited laboratory that provides relevant testing services.

Biocompatibility Testing of Biomaterials(图1)

biocompatibility testing determines if your product is safe for contact or implantation in the human body, which is required for regulatory approval. It is also an important component of medical device testing for regulatory pathways and agencies such as FDA, 510k, PMDA, etc.

Baijian.com Medical Laboratory provides biocompatibility projects:


sequence

project

standard

1

In vitro cytotoxicity assay

ISO10993-5,GB16886.5

2

Sensitization test

ISO10993-10,GB16886.10

3

Skin, intradermal and oral mucosal irritation tests

ISO10993-10,GB16886.10

4

Stimulus test

ISO10993-23

5

Acute systemic toxicity test

ISO10993-11,GB16886.11

6

Subacute systemic toxicity test

ISO10993-11,GB16886.11

7

Subchronic systemic toxicity test

ISO10993-11,GB16886.11

8

Chronic systemic toxicity test

ISO10993-11,GB16886.11

9

Heat source test

ISO10993-11,GB16886.11

10

Chromosome aberration test

ISO10993-3,GB16886.3

11

Micronucleus test

ISO10993-3,GB16886.3

12

Gene mutation testing

ISO10993-3,GB16886.3

13

AMES Test

ISO10993-3,GB16886.3

14

Thrombosis test

ISO10993-4,GB16886.4

15

Coagulation tests

ISO10993-4,GB16886.4

16

Platelet adhesion test

ISO10993-4,GB16886.4

17

Complement activation test

ISO10993-4,GB16886.4

18

Hemolysis test

ISO10993-4,GB16886.4

19

Muscle implant testing

ISO10993-6,GB16886.6

20

Subcutaneous implantation test

ISO10993-6,GB16886.6

21

Bone implantation test

ISO10993-6,GB16886.6

22

Material Characterization

ISO10993-18



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