The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies, with ISO 10993 comprising a series of standards (ISO 10993-1 to ISO 10993-20) for evaluating the biocompatibility of a medical device prior to a clinical study.
It replaces BS EN ISO 10993-1:1998 which has been withdrawn.
The most relevant standard for biocompatibility is the ISO 10993-1 standard.
The standard was developed for medical device and dental materials, and three types of contact categories are defined for devices:
- Surface
- External Communicating
- Implant
These device categories are further divided into three exposure periods:
- Limited (<24 hours)
- Prolonged (24 hours to 30 days)
- Permanent Contact (>30 days)
Primasil can supply a range of materials that meet the requirements defined in ISO 10993-1 for Surface Devices with "limited" (<24 hours) or "prolonged" (1 to 30 days) contact duration.
We do not offer materials intended for Permanent Contact.