Safety determination of Medical Devices through E&L testing

Risk based Safety Evaluation of Drug Delivery Device

Since 2005, the use of ISO 10993 Part 18 for the Chemical Characterization of medical devices has substantially increased in acceptance by regulatory agencies. In fact, the recent FDA guidance to the Industry on the use of 10993 for biocompatibility, along with both the upcoming changes in ISO 10993-1 and the recent/upcoming changes in the USP, there is a significant importance highlighted to evaluate safety through a risk-based process.  The primary source of information to use in the risk assessment is Chemical Characterization data. The actual manner to characterize those chemicals which may leach from a medical device and become available to the patient (directly or indirectly) has not been established specifically.

The experts on our team have worked directly with regulators and participated in standard-setting activities.  They have a unique understanding of how ISO 10993-18 coupled with ISO 10993-17 provides the medical device industry with the framework to develop customized programs to meet the needs of safety testing through the use of analytical chemistry and biological/toxicological assessment.

Material characterization per ISO 10993-18: When is it needed & how do I satisfy the requirements?

This is particularly important for combination products, implantable devices, many external communicating devices, and devices that utilize color additives or colorants. Extractables and Leachables as it relates to medical devices driven primarily by ISO 10993: Part 1, Part 12, Part 18 & Part 17.

ISO 10993 biocompatibility consists of the following parts, under the general title Biological evaluation of medical devices:

Part 1: Evaluation and testing within a risk management process

Part 2: Animal welfare requirements

Part 3: Tests for genotoxicity, carcinogenicity & reproductive toxicity

Part 4: Selection of tests for interactions with blood

Part 5: Tests for in vitro cytotoxicity

Part 6: Tests for local effects after implantation

Part 7: Ethylene oxide sterilization residuals

Part 9: Framework for identification & quantification of potential degradation products

Part 10: Tests for irritation & skin sensitization

Part 11: Tests for systemic toxicity

Part 12: Sample preparation & reference materials

Part 13: Identification & quantification of degradation products from polymeric medical devices

Part 14: Identification quantification of degradation products from ceramics

Part 15: Identification & quantification of degradation products from metals & alloys

Part 16: Toxicokinetic study design for degradation products & leachables

Part 17: Establishment of allowable limits for leachable substances

Part 18: Chemical characterization of materials

Part 19: Physico-chemical, morphological & topographical characterization of materials

Part 20: Principles & methods for immunotoxicology testing of medical devices

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