Providing Quality Chemical Characterization So You Can Improve Quality of Life

How Safe Is My Device?

Accurate extractables analysis of medical devices, coupled with toxicological risk assessment, can save time, money, and minimize risk when bringing your product to market. However, recent changes in ISO 10993-18:2020 have made conducting a chemical risk assessment even more challenging than ever before.

When Do I Need a Chemical Risk Assessment?

  • According to ISO 10993-1:2018, chemical risk assessment is the first step in performing a biocompatibility assessment.

  • As part of FDA submissions such as Investigational Device Exemption (IDE), 510(K) Premarket Notification, Premarket Approval (PMA).

  • The EU MDR has similar requirements for chemical risk assessment.

  • To evaluate a new material of composition or contact material as being chemically equivalent to an “old” material.

  • As a guideline for internal Quality Control.

Chemical Risk Assessment Workflow

The chemical risk assessment workflow may be viewed as a three-tiered structure composed of:

Click on elements above for more information

Step 1: Made explicit in ISO 10993-18:2020, the critical first step of the chemical risk assessment is information gathering. This involves collecting all available data on the medical device’s materials of construction, additive packages, surface treatments/coatings, etc. In addition to information on the compositional level, the information gathering step also includes collection of the manufacturing processing aids and processing conditions: e.g. machine oils, spin finishes, polishing compounds, sterilization modes, etc.


Essentially, the practitioner should consider anything that may be left behind on the device as a residue and result in subsequent patient exposure. In practice, the information gathering step is often challenging to thoroughly complete due to the use of proprietary mixtures/formulations in the device or its manufacturing process. Such information gathering efforts provide a baseline level of information that may be able to justify whether additional chemical characterization testing (extractables) is necessary. Furthermore, the information provides critical context for guiding analytical method selection, reference/surrogate standards employment, and is an invaluable aid in compound identification.

Step 2: For devices of greater risk or more uncertainty in materials/manufacturing, an extractable study is likely to be required, at minimum. Such extractable studies generally aim to remove either more chemical species than would be expected to leave the device under anticipated clinical conditions (exaggerated extraction), or aim to remove all chemical species that could conceivably be removed from the device (exhaustive extraction). For permanent implant devices, exhaustive extraction is performed.


Compounds identified through these extractions are first considered through a ‘worst case’ lens—e.g. the device suddenly dissolving and all potential extractables are released in a single bolus.


If the results of this extractable study and conservative risk assessment flag compounds at concentrations that present a potential toxicological concern, leachable studies may be necessary to more accurately estimate the actual patient exposure to these species under simulated clinical use conditions.

Step 3: After the extractable testing is complete, identified compounds and their concentrations are submitted for a toxicological risk assessment, generally by ISO 10993-17 (this process should be performed by a certified toxicologist). A key output of this assessment includes margin of safety (MoS) values for each chemical, however the process of evaluating the results should also consider if individual chemicals are “expected” and “unexpected’’ based on the device materials and manufacturing process, as well as evaluating variability between samples or manufacturing lots.


If some chemicals are found to present a potential toxicological risk (i.e. MoS near or less than 1), a targeted leachable study may be necessary in order to evaluate the actual concentration of the compound when the device is subjected to simulated end use conditions. Only compounds flagged as potentially above toxicological threshold need be evaluated in the leachable study.

Please contact us for more information on how we can assist in evaluating your devices to the new ISO 10993-18:2020 standard and workflows.

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