ISO 10993 Testing Services

Pace Analytical Life Sciences provides testing services for evaluating the biocompatibility of a medical device prior to a clinical study. The testing services that we provide support the following ISO 10993 standards:

• ISO 10993 – 7, Ethylene Oxide Sterilization Residuals
• ISO 10993 –13, Identification and quantification of degradation products from polymeric medical devices
• ISO 10993 – 14, Identification and quantification of degradation products from ceramics
• ISO 10993 – 15, Identification and quantification of degradation products from metals and alloys
• ISO 10993 – 18, Material characterization

The ISO 10993 testing services that we provide aid in the biological evaluation of medical devices. These testing services are performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. When selecting the appropriate tests for biological evaluation of a medical device, one must consider the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body.

Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.