Degradation Products

Degradation product testing is designed for generation, identification, quantification, characterization and toxicokinetic studies of degradation products, which is of particular interest from both a risk assessment and regulatory perspective.

According to ISO 10993 standard, STEMart provides comprehensive degradation product testing based on the material chemistry and end-use biological environment for polymeric, ceramic and metallic medical devices.

Standard for Degradation Product Test

• ISO 10993-13
• ISO 10993-14
• ISO 10993-15
• ISO 10993-16

Degradation Product Test Capability

• Polymeric medical device

Hydrolytic or oxidative degradation products generated by a chemical alteration of the finished polymeric device.

• Ceramic medical device

Degradation products generated by a chemical dissociation of ceramics.

• Metallic and alloy medical device

Degradation products generated by a chemical alteration of the finished metallic and alloy device.

Degradation Product Test Methods

• For polymeric medical device
• Accelerated degradation test
• Real-time degradation test
• For ceramic medical device
• Extreme solution test (A test based on a pH 3 citric acid buffer solution)
• Simulation solution test (A test based on a pH 7.4 ± 0. 1 buffer solution)
• For metallic and alloy medical device
• Electrochemical test
• Immersion test

Degradation Product Identification Techniques

• Chromatographic methods
• GC
• HPLC
• Size exclusion chromatography (SEC)
• Spectroscopic methods
• Ultraviolet spectroscopy
• Infrared spectroscopy
• Nuclear magnetic resonance spectroscopy (NMR)
• MS
• Atomic Absorption Spectroscopy (AAS)

Characterization Analysis for Degradation Product

• Solution viscosity, including molecular mass average and branching
• Rheology, including melting range, melt viscosity, thermal stability and molecular weight distribution
• Swellability, including crosslink density
• Thermal analysis, including differential scanning calorimetry for glass transition, melting range or softening point, blends
• Density
• Microstructural characterization
• X-ray characterization
• Surface area characterization

Toxicokinetic Studies for Degradation Product

• Absorption rate
• Distribution rate
• Metabolism and excretion

With rich experience in method development for degradation product test, STEMart provides comprehensive degradation product testing service to help medical device manufacturer to verify product safety. If you have additional questions about Degradation Products or would like to find out more about our services, please feel free to contact us.

References

• International Organization for Standardization. Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices. ISO 10993-13.
• International Organization for Standardization. Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics. ISO 10993-14.
• International Organization for Standardization. Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys. ISO 10993-15.
• International Organization for Standardization. Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables. ISO 10993-16.