The ISO 10993 series of standards, recognized by the FDA and notified bodies, covers methods and tools for verifying and validating the biological safety of medical devices. One component of this group is ISO 10993-13, a critical standard for assessing the biological safety of polymeric medical devices that may degrade over time. The standard defines general requirements for the design of tests in simulated environments intended to induce the formation of degradation products that replicate what will be formed in vivo. This testing is essential for regulatory compliance and ensuring patient safety because degradation in the implant environment may generate products with unexpected chemical structures that are not pre-existing in the device. Here’s what you need to know:

Key Aspects of ISO 10993-13 Testing

Purpose

  • Identifies and quantifies degradation products from finished polymeric medical devices
  • Evaluates potential biological risks from chemical alterations during device use

Test Methods

  • Accelerated degradation test (screening method)
  • Real-time degradation test in simulated environment

Scope

  • Applies to non-resorbable polymers
  • Focuses on chemical degradation (not mechanical stress, wear, or biological factors)

Benefits of ISO 10993-13 Compliance

  • Supports regulatory submissions worldwide
  • Demonstrates device safety and biocompatibility
  • Enables comprehensive risk assessment

Our Approach to ISO 10993-13 Testing

Strategic Test Design

We work closely with manufacturers to develop customized degradation studies that:

  • Simulate relevant (accelerated, where feasible) physiological conditions
  • Account for intended use and duration of contact
  • Distinguish degradation products from leachables and residuals

Advanced Analytical Capabilities

  • State-of-the-art mass spectrometry for compound identification
  • Thermal analysis and rheology to evaluate changes in polymer structure
  • Expertise in characterizing novel polymeric materials and their breakdown products
  • Specialized software to assist with challenging degradation product analysis

Comprehensive Risk Assessment

We provide the data and expertise needed to:

  • Evaluate biological hazards of degradation products
  • Conduct toxicological risk assessments (ISO 10993-17)
  • Support overall biocompatibility evaluation (ISO 10993-1)

Partner with Experts in Polymeric Device Testing

Our experienced team of scientists is dedicated to helping medical device manufacturers navigate the complexities of degradable polymer testing. We offer:

  • Decades of polymer science and chromatographic experience
  • In-depth knowledge of regulatory requirements
  • Customized testing strategies
  • Efficient project management
  • Clear, actionable results to support your submissions

Contact us today to discuss your ISO 10993-13 testing needs and ensure the safety and success of your polymeric medical devices.