Safety & biocompatibility framework

Safety and biocompatibility are central considerations in the development, communication and use of photopolymer materials for additive manufacturing. At 3Dresyns®, safety and biocompatibility are addressed through a system-based and process-aware framework that recognizes the multivariable nature of photopolymer 3D printing.

Biocompatibility is not an intrinsic property of a liquid resin alone. It is an outcome of the complete material–process–application system.

Definition of biocompatibility in additive manufacturing

In the context of photopolymer additive manufacturing, biocompatibility refers to the ability of a printed part, produced under defined conditions, to perform its intended function without causing unacceptable biological responses in a specific application.

Biocompatibility outcomes depend on material formulation, formulation version, printer technology, printing parameters, post-processing workflow and intended use conditions.

Process dependency and system-level responsibility

Printing, washing and post-curing conditions directly influence polymer conversion, surface chemistry and residual extractables. As a result, changes in workflow may significantly affect both safety and biocompatibility outcomes.

For this reason, safety and biocompatibility must be evaluated and maintained at the system level rather than assumed from material composition alone.

Scope and limitations of biocompatible material systems

3Dresyns develops photopolymer systems intended to support applications where biocompatibility considerations are relevant, including medical, dental, research and laboratory contexts.

These materials are designed to operate within defined application scopes and qualified workflows. They are not presented as universally biocompatible under all conditions or for all uses.

Relationship between safety, testing and use

Safety and biocompatibility assessment relies on appropriate testing performed under reference configurations and recognized standards. Testing outcomes are valid only for the specific material version and workflow under which they were generated.

Instructions for Use (IFU) define the qualified processing conditions required to achieve expected performance and safety outcomes. Deviations from IFU may invalidate testing results and compromise biocompatibility.

Responsibilities of material suppliers and users

3Dresyns is responsible for developing materials, defining qualified workflows, providing reference testing data and ensuring traceability through versioning and lot control.

Responsibility for final application validation, regulatory compliance and correct implementation rests with the device manufacturer, laboratory or user applying the material within a specific use case.

Transparent and responsible communication

3Dresyns is committed to transparent and responsible communication of safety and biocompatibility information. Performance data and guidance are presented as typical outcomes obtained under defined reference conditions, not as absolute or unconditional guarantees.

This approach supports informed decision-making while acknowledging the inherent variability of photopolymer additive manufacturing processes.

Governing principle

Safety and biocompatibility in photopolymer additive manufacturing are system-dependent outcomes. They represent typical responses obtained under qualified printing and post-processing workflows, not intrinsic properties of the liquid resin alone.