Sterile
The STERILE symbol under EN ISO 15223-1 marks a device supplied sterile. Where no suffix letter follows, steam sterilisation is the process to be understood.
Process: validation is governed by EN ISO 17665.
Advantages: no toxic residue, no degassing step, low cost and readily monitored.
Limits: only thermostable materials are suitable. Natural latex and nitrile at glove wall thickness are damaged by steam.
Frequently asked questions
What does STERILE without a suffix stand for?
Steam sterilisation with saturated steam in an autoclave, governed by EN ISO 17665. Suffix letters denote different processes: EO for ethylene oxide, R for ionising radiation.
Are medical single-use gloves steam sterilised?
Generally not. Thin-walled elastomers are damaged by moist heat. Sterile surgical gloves are predominantly radiation sterilised and therefore carry STERILE R, less commonly STERILE EO.
What parameters are typical for steam sterilisation?
121 °C with around 15 minutes hold time or 134 °C with around 3 minutes are common. The specific parameters and their validation depend on EN ISO 17665 and the particular load.