Biocompatibility Testing of Biomaterials
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 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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