Burgeoning alongside advancements in the medical industry itself, innovations in medical devices have blossomed over the past few centuries. Even before a rolled up notebook to hear a woman’s heart in 1816 served the initial makeshift duty of a stethoscope and long before exalted technologies like robotics and lithium-ion batteries made their way into the industry, the biocompatibility of patients with medical devices has been crucial.
Essential to comprehending the harm inflicted onto humans by medical devices is risk management, a concept featured throughout the ISO 10993 series of international standards for the biological evaluation of medical devices.
Risk Management and the Biological Evaluation of Medical Devices
The term medical device covers an expanse of devices, ranging from a single material to numerous components made of a plenitude of materials.
Similarly, the range of biological hazards is wide and complex. Besides the five million trillion trillion (5×10^30) bacteria occupying planet earth, a variety of medical device materials and components available are utilize, each enhancing the variability for adverse effects.
Adverse biological responses from one application might not be considered adverse in another application. Furthermore, biocompatibility is just one of several factors that determine the functionality of a medical device.
To protect humans from hazards, biological evaluations of medical devices address a variety of issues. Since biological hazards often result from risk, this falls within a risk management process.
According to ISO 10993-1:2018 – Biological Evaluation Of Medical Devices – Part 1: Evaluation And Testing Within A Risk Management Process, a “biological risk” is understood as the:
“combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm.”
Testing of Medical Devices Within a Risk Management Process
ISO 10993-1:2018, describes the biological evaluation of medical devices within a risk management process. This document specifies other integral provisions for this process, including assessing the biological safety of and categorizing a medical device, as well as the identifying gaps in a data set through risk analysis and additional data sets needed for analysis.
ISO 10993-1:2018 applies to biological evaluation of active, non-active, implantable, and non-implantable medical devices. The materials this standard evaluates are expected to have direct contact with either the patient’s body during the intended use of the medical device or, if used for protection, the user’s body, (as with surgical gloves and masks).
Chemical Characterization of Medical Device Materials Within a Risk Management Process
According to principles in ISO 10993-1:2018, biological risk analysis depends on knowledge of the material formulation, existing nonclinical and clinical safety and toxicological data, and the nature and duration of body contact with the medical device.
Expanding upon these requirements, ISO 10993-18:2020 – Biological Evaluation Of Medical Devices – Part 18: Chemical Characterization Of Medical Device Materials Within A Risk Management Process specifies a framework for the identification and quantification of constituents of a medical device. Such a framework allows for the identification of biological hazards and the estimation and control of biological risks from material constituents.
Using a stepwise approach, the chemical characterization in accordance with ISO 10993-18:2020 can yield information on medical device configuration, material composition, extractables, leachables, and/or the chemical substances introduced during manufacturing process (e.g. mold release agents, process contaminants, and sterilization residues).
ISO 10993 Standards
Just as medical devices cover an expansive range of components and materials, other documents in this family focus on a range of pertinent areas. These include:
This standard has a corrigendum document published in 2009.
All these standards are available together as the ISO 10993 – Biological Evaluation of Medical Devices Package.