Risk assessment is a multi-step process which produces estimates of risk of an adverse health effect occurring as a consequence of ingesting, inhaling, and/or absorbing one or more toxic substances. An expert toxicologist must identify the substances of potential significance present at the site since these will be the focus of the risk assessment process. ISO 10993-17:2023—Biological Evaluation Of Medical Devices – Part 17: Toxicological Risk Assessment Of Medical Device Constituents specifies requirements for a toxicological risk assessment process for specific medical device constituents that is used within the biological evaluation process provided by ISO 10993-1.
What Is ISO 10993?
A medical device or material that has direct or indirect contact with the patient’s body or the user’s body is expected to perform its intended use while being free from unacceptable risks, including biological and toxicological risks. For this reason, medical devices are typically subject to a biological evaluation within a risk management process to assess their safety. ISO 10993 Biocompatibility and Risk Management specifies a process through which the manufacturer of a medical device can identify biological hazards associated with the medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device.
Why Is Toxicology Important in Risk Assessment?
The relationship between a hazard and potential for exposure defines risk. A toxicological risk assessment is a safety evaluation of a product based on its composition and intended uses. It determines whether or not a product poses a potential risk for the toxicological endpoints measured and can be amended to also include suggested labeling phrases, warnings, and warning symbols that may be necessary on the package of the product.
A well-organized toxicological risk assessment reliably measures the likelihood of adverse human health effects from a potential toxic exposure. It can also offer guidance with respect to property remediation, disposition, and future-use issues. The expert toxicologist must pragmatically research contributing and historical factors, perform the required dose and risk calculations in the proper order, professionally summarize the results, and communicate written findings in a scientifically-objective manner such as that laid out by ISO 10993-17:2023.
What Is ISO 10993-17?
ISO 10993-17:2023 specifies the process and requirements for the toxicological risk assessment of medical device constituents. The toxicological risk assessment process is based on the principle that the biological evaluation and risk assessment process are most effective when the minimum information necessary is used to assess if exposure to a harmful dose of any medical device constituent can occur. The process described in this standard applies to chemical characterization information obtained in line with ISO 10993-18.
The toxicological risk assessment guidelines can be part of the biological evaluation of the final product, as described in ISO 10993-1. ISO 10993-17:2023 is applicable when a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g., extractable data or leachable data) is required to determine whether the toxicological risks related to the constituents are negligible or tolerable. Thus, the methods and criteria in ISO 10993-17:2023 are used to assess whether exposure to a constituent is without appreciable harm. The extent to which constituent information is needed depends on what is known about the material formulation, manufacturing process (i.e., processing aid chemicals, process steps, etc.), what nonclinical or clinical information exist, and on the nature and duration of body contact with the medical device.
ISO 10993-17:2023 is intended for use by toxicologists or other knowledgeable and experienced professionals, appropriately qualified by training and experience, capable of making informed decisions based upon scientific data and a knowledge of medical devices.
Biological Risk Assessment
Biological risk assessment is one of the key principles of biosafety, which strives to protect laboratory workers, the environment, and the public from potentially hazardous biological agents, toxins, or hazards (biohazards include biological agents and toxins infectious to humans, animals, wildlife, or plants such as parasites, viruses, bacteria, fungi, prions, and biologically-active materials such as toxins, allergens, and venoms). It is the process used to identify the hazardous characteristics of an infectious organism, the activities that could lead to exposure, the chances of contracting a disease after an exposure, and the consequences of an infection.Risk assessment provides the necessary information to determine the appropriate biosafety measures (facility characteristics, microbiological practices, safety equipment, etc.) for each project conducted in a laboratory. Moreover, the process, requirements, criteria, and methods specified in ISO 10993-17:2023 are intended to yield the following information that is useful in the overall biological risk assessment of the final product:
- Whether constituents present in, on or extracted from the medical device are at a quantity that can be a potential source of harm to health
- Derivation of a tolerable intake or tolerable contact level, for a constituent over a specified time period, on the basis of body mass or surface area, that is considered to be without appreciable harm to health
- A worst-case estimated exposure dose for each constituent and subsequent toxicological risk estimation
- A toxicological risk estimate based on the tolerable intake or tolerable contact level and on the worst-case estimated exposure dose for each constituent
ISO 10993-17:2023—Biological Evaluation Of Medical Devices – Part 17: Toxicological Risk Assessment Of Medical Device Constituents is available on the ANSI Webstore.