Biocompatibility Supporting Documentation for Prolonged Skin Contact
This page explains what 3Dresyns® can provide when customers request supporting documentation for resins used in applications involving prolonged skin contact. It is intended to help medical device manufacturers prepare their regulatory documentation and understand responsibilities related to biological evaluation.
Important clarification
3Dresyns® supplies photopolymer resin materials, not finished medical devices. Biological safety and regulatory compliance are determined at the level of the finished device and depend on the complete manufacturing workflow implemented by the legal manufacturer.
ISO 10993-1: what it means in practice
ISO 10993-1 is a framework for the biological evaluation of medical devices based on intended use and contact duration. It is applied through a risk-based approach at the device level. Therefore, final determination of suitability for prolonged skin contact must be performed by the legal manufacturer, using their validated process and risk management file.
What 3Dresyns® can provide
For resins intended for biocompatible and biomedical applications, 3Dresyns® can provide a documentation pack that typically includes:
- SDS (Safety Data Sheet) which is supplied upon request
- TDS (Technical Data Sheet) which is included in the online product information
- IFU (Instructions for Use) describing recommended printing, cleaning and post-curing conditions
- Material identification and version/lot traceability information which is supplied in each invoice and product label
- Process-Dependence Guidance explaining how workflow parameters may influence conversion and extractables/leachables
- Regulatory Responsibility Statement clarifying that device-level compliance remains the responsibility of the legal manufacturer
Process dependence and why it matters
Biocompatibility outcomes are not an intrinsic property of the liquid resin alone. They depend on achieving the maximum achievable degree of conversion under controlled and validated processing conditions and reducing unreacted species, extractables, and leachables to acceptable levels for the intended use.
Key factors that may influence outcomes include:
- printer technology, wavelength, optical output, and exposure settings
- part geometry (thickness, internal channels) and surface area-to-volume ratio
- cleaning chemistry, bath management, agitation, and drying
- post-curing dose and, when required, thermal post-curing
- finishing operations (e.g., sanding, polishing, tribofinishing)
- final cleaning, packaging, storage, and sterilization (if applicable)
Public statement suitable for regulatory files
The following wording can be used as a general public statement to support regulatory documentation. It does not replace device-level validation performed by the legal manufacturer.
Biocompatibility Supporting Documentation Statement
3Dresyns® photopolymer resins intended for biocompatible and biomedical applications are supplied with SDS/TDS and an IFU describing recommended printing, cleaning and post-curing conditions. When processed strictly according to the IFU, the workflow is designed to support the maximum achievable degree of conversion under controlled and validated processing conditions and to reduce unreacted species, extractables and leachables.
Biological evaluation and regulatory compliance of the finished medical device, including suitability for prolonged skin contact, must be determined by the legal manufacturer based on the complete manufacturing and finishing workflow, intended use conditions and risk management documentation.
How to request your documentation pack
To receive resin-specific documentation (SDS/TDS/IFU and supporting statements), please contact us and provide:
- resin product name(s) and version(s)
- lot number(s)
- intended use and contact duration
- printing technology, light intensity, and wavelength
- planned cleaning and post-curing equipment
Contact: info@3dresyns.com