Plastic components in medical devices may require additional scrutiny beyond the ability of a material’s performance characteristics to meet an application’s requirements.
For the healthcare market issues such as biologic compatibility, drug interaction, and brand identification are routinely considered as part of a material’s selection criteria. This white paper reviews all the additional requirements that need to be considered when colored plastics are used in medical devices.
Topics discussed include:
- Establishing criteria for specifying color
- Regulations applicable to plastics and color
- Selection and testing of materials and colorants for compliance
- Color control and change management issues