The Table in Annex A (informative) of ISO 10993-1 gives suggestions for the evaluation of biological effects for all medical devices which contact human patients. This is not a prescriptive measure for testing, but rather a guide for evaluating biological safety within the risk management process.
While there is commonly more than one way to evaluate the biological safety of a medical device, multiple, critical steps must be incorporated into any evaluation and subsequent biological safety plans developed to ensure that all risks are addressed. Throughout the process, there are benefits of utilizing a biological evaluation plan prior to testing as this can minimize unnecessary testing, maintain compliance with all pertinent standards/regulations and provide evidence for the ultimate goal of ensuring product safety.
Acknowledging many manufacturers intend to market their products internationally, the evaluation plan is also an integral part in incorporating different standards and regulations enforced by various governing agencies. Expertise spanning across numerous regions is a critical component to these plans and the subsequent testing.
From FDA: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”: Considering the potential biological impact, a plan should be developed to address the knowledge gaps either by biocompatibility testing or other evaluations that appropriately address the risks. The interpretation of the overall biocompatibility evaluation should be considered in the appropriate benefit-risk context.
In this webinar, biological safety expert Mike Hendershot (Manager of Biological Safety, NAMSA) will discuss the use of biological evaluation plans and how attendees can:
- Define a plan to ensure biological safety
- Communicate the plan to team members, company associates and medical device regulators
- Leverage known information about the constituents of the device
- Identify and characterize biological and toxicological hazards associated with the medical device product in an effort to characterize risk
- Document how a manufacturer may use the requirements of ISO 10993-1 to assure biological safety
- Utilize the step-wise approach to save time and money