To evaluate the safety of medical devices, a risk management approach is advocated in multiple regulatory documents, such as ISO 14791 Medical Devices (Application of risk management to medical devices) and ISO 10993 Biological Evaluation of Medical Devices – Part 1 (Evaluation and testing within a risk management process).

The above approaches are intended to span the design, testing and product lifecycle of a medical device, and involve evaluating potential patient risk of both initial marketed devices and subsequent changes to materials of construction, suppliers, manufacturing or processing.

However, in 2018, significant changes were made in Annex A of the updated ISO 10993-Part 1 Standard, including new endpoints for biological evaluation, which include:

  • Physical and/or chemical information
  • Material-mediated pyrogenicity
  • Subacute systemic toxicity
  • Chronic toxicity
  • Carcinogenicity

The updated Standard also mandates that information be provided on most device physical properties, materials of construction, manufacturing and finishing processes that are relevant to the biological safety of a patient.

NAMSA invites you to access our white paper, “Medical Device Biological Evaluation Reports: Relevance to the Revised ISO 10993-Part 1: 2018,” to learn how the new standard emphasizes the importance of material characterization information in biological evaluation reports. (Authors: Elaine Daniel, PhD, DABT; Principal Toxicologist, NAMSA and Duane Mancini, M. Sc.; MRO Strategy Advisor, NAMSA).

Please fill out the form below to access this white paper.