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Biocompatible 3D Printing Materials: ISO 10993 and USP Class VI Explained
Designing a medical device, a lab component or a part that touches skin? Here is what ISO 10993 and USP Class VI actually mean, how they differ, and what to ask before you print.
What does “biocompatible” mean?
A biocompatible material has been tested to show it does not cause an unacceptable biological reaction — such as toxicity, irritation or an allergic response — when it contacts the body in a defined way. Biocompatibility is never absolute: it always depends on what touches the body, where and for how long.
ISO 10993 explained
ISO 10993 is an international series of standards for the biological evaluation of medical devices. Rather than one single test, it is a framework: the tests required depend on the type of body contact (for example skin, mucosal membrane or blood) and its duration (limited, prolonged or long-term).
Common evaluations in the series include:
- Cytotoxicity — does the material harm cells?
- Sensitisation — can it cause an allergic reaction?
- Irritation — does it irritate skin or tissue?
Further tests apply for longer or more invasive contact.
USP Class VI explained
USP Class VI comes from the United States Pharmacopeia. It classifies plastics using a set of biological reactivity tests, and Class VI is the most rigorous of the plastic classes. It is widely used as a benchmark for materials in medical, pharmaceutical and laboratory components.
ISO 10993 vs USP Class VI
| ISO 10993 | USP Class VI | |
|---|---|---|
| What it is | A framework of standards for evaluating medical devices | A classification of plastics by biological reactivity tests |
| Tests chosen by | Type and duration of body contact | A fixed set of tests for the class |
| Typical use | Medical device development and regulatory submissions | Material benchmark for medical, pharma and lab components |
Biocompatible 3D printing at Quick 3D
Quick 3D’s material library includes ISO 10993 biocompatible materials with full traceability, and materials with USP Class VI certification. Tell us your application and we will recommend a suitable material and share its documentation.
Typical uses include device prototypes, clear fluidic parts, anatomical models, and jigs and fixtures for device production lines. See 3D printing for medical and healthcare.
Questions to ask your supplier
- Which standard, and which specific tests, does the material certificate cover?
- Can you provide the certificate, technical data sheet and safety data sheet?
- What post-processing and cleaning does the material supplier specify?
- Is the material lot traceable?
- Which process and resin or powder will my part be printed in?
For more on certifications, read What does UL94 V-0 mean? and our checklist for choosing a 3D printing service.
Frequently asked questions
What is ISO 10993?
ISO 10993 is an international series of standards for the biological evaluation of medical devices. The tests required depend on the type and duration of body contact.
What is USP Class VI?
USP Class VI is a United States Pharmacopeia classification for plastics based on biological reactivity tests. Class VI is the most rigorous of the plastic classes.
Does a biocompatible material make my device approved?
No. A material certificate covers the material under specific test conditions. Processing, cleaning and sterilisation affect the final part, and the device manufacturer must validate the finished device.
Does Quick 3D offer biocompatible 3D printing materials?
Yes. Our material library includes ISO 10993 biocompatible materials with full traceability and materials with USP Class VI certification. We can recommend a material and share its documentation.
Need a biocompatible material?
Tell us your application and contact type. We’ll recommend a suitable material and share its certificates and data sheets.
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