ISO 10993-1 Evaluation for commonly used materials


Hi All,

We are developing a medical device, that incorporates handles, a chinrest and headrest, that are intended to contact a patient during normal use.

The nature of body contact, according to ISO 10993-1:2018 Table A.1., is intact skin, for a duration of less than 24 hours (in reality, it will be around 10 minutes).

The handles will likely be made of 316 stainless steel. Following the flowchart of figure 1, it is quite difficult to prove the material is the same material as in a marketed device, as this information is not available from medical device manufactures. if we were to prove this, the manufacturing process and sterilization process will likely differ.

It seems the option is then to conduct research/ literature review to determine the biocompatibility of the material, to prevent testing. For such a commonly used material, it seems redundant to spend much time conducting a literature review, especially considering the nature of the contact. I understand there are other factors within the manufacturing process of the part, however for this question, I am concerned with the material itself.

What is the best way to navigate the biocompatibility evaluation of a commonly used material, in a body contact nature similar to this, short of reinventing the wheel, through conducting testing or a new literature review?
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Super Moderator
In addition to @yodon's advise to jump to Attachment G of FDA's guidance, there are two sections in ISO 10993-1:2018, that might be useful to you:

section 5.2.2 and the NOTE contained therein:
Some medical devices used in either sterile or non-sterile environments include components that can come into contact with a user’s ungloved hands [...] If these types of components can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further biological evaluation is needed.

section 5.3.2:
5.3.2 Transitory-contacting medical devices Some medical devices with limited exposure (A) have very brief/transitory contact with the body [...] These generally would not require testing to address biocompatibility. [...]
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