toxicology/biocompatibility
Welcome to Ethox STS Toxicology/Biocompatibility
We pride ourselves on providing a one-on-one, interactive approach with custom services designed specifically to meet our clients' individual biocompatibility assessment needs. Ethox STS guides their clients through all stages of their project—from the initial material characterization testing through to final QC release testing.
our focus
• Protocols designed to meet FDA, ISO, JP, and EP requirements.
• One-on-one consultation to assist with:
- Study Design
- Project Support
- Troubleshooting
• In-house AAALAC accredited vivarium
determine your needs
 Examination of a device before testing is critical in deciding how the testing is to be conducted (i.e. what parts to extract, duration of patient exposure, applicable regulatory limits).
The attached tables, published in the USP, provide guidance for testing needs.
To assist you in determining your test needs
see:
ISO 10993-1 Test Matrix
Call us! We'll walk you through the requirements and help you select the appropriate tests.
our services
The most frequently requested Ethox STS tests include:
• Irritation
• Intracutaneous Reactivity
• Sensitization
• Cytotoxicity
• Acute Systemic Injection (Single Dose)
• Systemic Toxicity (Repeated Exposure)
• Implantation
• Hemocompatibility
• Pyrogenicity (Rabbit and Bacterial Endotoxin Test (LAL))
• Acute and Subchronic Evaluations
• Abnormal Toxicity
• Safety Testing
Ethox STS offers a wide range of Toxicology Testing. Learn more...
related services
Coordinating Client Projects
Toxicology performs studies separately or in conjunction with other Ethox STS services. This approach serves to streamline clients’ studies, utilizing our multi-service capabilities.
• Microbiology testing
• Analytical Chemistry
• Reusable medical device testing
• Assembly & Packaging
• Contract Sterilization
• Biological Indicators
certifications
Ethox STS Toxicology performs testing in compliance with the guidelines provided by ANSI/AAMI/ISO 10993 and USP.
• AAALAC accredited since 1986
• Audited by USDA, NYSDOH
• Member of AALAS
See more certifications
To learn more call Annetta Herrington at 1.800.836.4850 or e-mail us!
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