Biocompatibility Testing/ISO 10993 Series

Accurately Evaluate Biocompatibility to Ensure Medical Safety

Biological evaluation plans and reports compiling service.
Regulatory support team standby for ISO 10993 compliance.
Customized biocompatibility evaluation and testing solutions.
One-stop medical device analysis services including other related analysis projects.
Professional team.
Advanced laboratory equipment.
Timely response.

Biocompatibility refers to the ability of a material to elicit an appropriate response at a specific site in the body, covering the complex biological, physical, and chemical interactions between the material and the host, including important aspects such as tissue compatibility and blood compatibility. As a crucial characteristic of the interaction between materials and the human body, it determines the safety and effectiveness of medical devices in clinical applications. Whether it is short-term or long-term contact, a series of adverse effects may occur between the material and the body. Therefore, biocompatibility is an essential consideration and key evaluation index in the testing and analysis of medical devices.

AltaNovate offers comprehensive and professional biocompatibility analysis services for medical devices in accordance with ISO 10993, along with regulatory support services for market access. Contact us for any needs.

Fig.2 Workflow of Biocompatibility Testing

Our Service

AltaNovate follows biosafety and biofunctionality principles to ensure patient safety and product efficacy through Rigorous in vitro and in vivo tests. Meanwhile, by comprehensively considering device nature, contact duration, and anatomical location, plus the FDA modification matrix, the requirements for biocompatibility testing and evaluation endpoints are determined.

Our biocompatibility testing service includes but are not limited to:

Testing Item	Standard	Testing Purpose
Cytotoxicity Testing	ISO 10993 - 5	To evaluate cell damage or death potential
Irritation Testing	ISO 10993 - 23	To assess local tissue damage or inflammation
Sensitization Testing	ISO/TS 11796:2023	To evaluate allergic or hypersensitivity risks
Hemocompatibility Testing	ISO 10993 - 4	To examine blood component impacts and adverse reactions
Pyrogenicity Testing	ISO 10993 - 11	To detect pyrogenic substances and levels
Implantation Testing	ISO 10993 - 6	To observe tissue-device interactions post-implant
Genotoxicity Testing	ISO 10993 - 3	To test genetic material damage potential
Degradation Assessment	ISO 10993 – 13/14	To analyze the degradation process and product biocompatibility

Need Biocompatibility Testing?

Get in Touch

AltaNovate is your top choice for medical device analysis! We provide one-stop analysis services covering biocompatibility testing, sterility testing, mechanical testing, etc. Regardless of the type of your medical device and the specific testing service it requires, we are capable of offering customized testing solutions. Contact us now for free initial consultations and customized analysis.

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