The two standards, ISO 10993 on biocompatibility and ISO 22196 on antibacterial efficacy, address two different issues: On the one hand, material compatibility; on the other,  the reduction of bacteria on the surface. Biocompatibility assesses whether detachable components of the material can cause biological effects. 

Appropriate cell or tissue models are used to assess potential cytotoxicity  (ISO 10993‑5), sensitisation potential (ISO 10993‑10) or irritation (ISO 10993‑23). The test for antibacterial efficacy in accordance with ISO 22196, on the other hand, determines whether and to what extent the number of viable bacteria (usually E. coli and Staphylococcus aureus) on the surface of a material is reduced within a defined period of time.

Which standard is appropriate depends on the range of applications and the resulting requirements. Biocompatibility in accordance with ISO 10993 is particularly relevant in the medical and healthcare sectors, as well as in any context where a material may come into regular or prolonged contact with the body (e.g. therapy, dialysis, infusion, rest and treatment beds). Antibacterial efficacy in accordance with ISO 22196 may also be required in medical settings, but is frequently sought after for applications with a heightened focus on hygiene in commercial, industrial and private settings.

If you have any questions regarding the appropriate safety standards, our VOWAteam will be glad to assist you.