Test plan builder

Describe the device

Tell us how the device contacts the body and we will work out which endpoints ISO 10993-1:2025 points to, what each target market expects, and how much material to send. If different parts of the device make different kinds of contact, build it component by component — each contact profile becomes its own test article.

Project or device name

Intended use

In your own words. This is read by the scientist who reviews your scope.

Contact type

Contact duration

Target markets

Patient-contacting components

Extraction severity

Auto follows ISO 10993-18, and goes exhaustive at prolonged contact when the United States is a target market.

Implantation timepoints

2 weeks 12 weeks 26 weeks

Each period needs its own specimen set and carries histopathology on the timeline.

Options

Reusable — test as-manufactured and end-of-life Add a 15% overage buffer Chemistry in triplicate

Guidance only. This is a planning aid, not a validated regulatory instrument. It is not a biological evaluation plan and not a formal recommendation for your device — it reflects the information you enter and the published standards, nothing more. Have a formal assessment completed before you rely on it.Speak with an expert →What a BEP does →

Suggested evaluation

Describe the device to begin

Choose a contact type and a contact duration and the suggested evaluation appears here, with the reasoning for each endpoint.