EN ISO 10993-1 is the framework standard for the biological evaluation of medical devices. It does not prescribe a particular test; it defines the logic by which the necessary tests are selected for a given device.
The two axes of classification
The tests required depend on two parameters: the nature of contact (intact skin, mucosal membrane, breached surface, blood, tissue) and its duration (up to 24 hours, 24 hours to 30 days, over 30 days).
Typical tests
- Cytotoxicity — the effect on cell culture.
- Sensitisation — the potential to cause an allergic reaction.
- Irritation or intracutaneous reactivity.
- Acute systemic toxicity.
- Haemocompatibility — where there is blood contact.
The link to PPE
The standard becomes relevant to PPE when a product is dual-purpose — a glove that also qualifies as a medical device, or a mask used in patient contact. In those cases both sets of regulatory requirements must be satisfied in parallel.