chapter  19
50 Pages

Leachables and Extractables from Medical Devices

Under International Organization for Standardization (ISO) 10993 and current U.S. Food and Drug Administration (FDA) regulatory guidelines (FDA, 2013) and expectations, a critical function of safety assessments for medical devices with internal body (“systemic”) contact for (potentially) 29 days or more includes the identication and quantication of chemical compounds that may migrate out of a device and into an individual. This consideration is also an essential part of the risk analysis and risk evaluation process for medical devices, per ISO 14791: Application of risk management to medical devices.