Standards
ISO 10993-1
In one line
Biological evaluation of medical devices within a risk management process.
Definition
ISO 10993-1:2018 describes the general principles governing the biological evaluation of medical devices within a risk management process, including selection of evaluation tests based on tissue contact and duration.
Devices are categorized by nature of contact (surface, externally communicating or implant) and duration (limited up to 24 hours, prolonged up to 30 days, long-term over 30 days), which determines the biological endpoints to address. The standard stresses using existing data, chemical characterization and risk assessment before animal testing. Other parts of the 10993 series describe specific tests. FDA's guidance on ISO 10993-1 adds US-specific expectations.
Why it matters
Biocompatibility documentation is a routine requirement for any patient-contacting device. FDA's recognized version aligns with ISO 10993-1:2018 plus FDA-specific guidance.
Common pitfalls
- •Failing to integrate biocompatibility evaluation into the overall risk management process can lead to overlooked hazards.
- •Selecting inappropriate test methods based on incorrect assumptions about device contact or duration can result in inadequate biological evaluation.
- •Not considering the manufacturing process and its potential impact on the device's biocompatibility can lead to non-conformance.
- •Ignoring changes in device materials or intended use can invalidate previous biocompatibility assessments.
- •Solely relying on material certificates without conducting device-specific testing when necessary is a common pitfall.
Sources