Biological evaluation procedure or plan


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Hi , hope all of you being well
can anybody help me about a procedure or plan template of biological evaluation for medical devices according to iso 10993-1 ?


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I am assuming you are having a service supplier perform this testing. I would suggest that your org identify the need for subject testing in Design Control. Your Supplier Control procedures will evaluate the the service provider for compliance to <insert standard name(s)>. If the supplier is deemed acceptable, your purchase order or better yet a quality agreement would specific who does what I would ask you supplier to deliver a plan and a report is the short answer. The plan would include what is the intended use of the material and define what testing is required. Your org can choose to approve the plan and report. Those supplier provided reports can then become Objective Evidence in your QMS.

Edit: Rely on your supplier for the details on how to perform the biological evaluation. That's what their QMS is for.

Make sense? Was my assumption wrong? Have fun; enjoy the ride. Hope this helps.
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you may want to have a look into ISO 10993-1:2018, Fig 1, which provides you with a flowchart that walks you through the evaluation process. Section B.2.2 tells you a little bit about the evaluation plan.

A word of caution: without previous exposure to / experience in biocompatibility evaluations, you may want to to seek professional support (also in line with ISO 10993-1:2018, section 4.1 - quote "the biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.")



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Great addition from planB. The Biological Eval is ultimately a Design Verification activity to ensure the individual material and or product meets the safety standard. Your Design Control should result in a verifiable specification....."shall meet ISO10993 <specifics>". As the org placing the product on the market, it is up to you to navigate the standard in collaboration with the service provider.
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