S
6 Posts in this encyclopedia categorySimulant Solutions
Comparable substitute, for the actual substance to be tested. For example, the simulant solution acetic acid 3% is used for testing products in contact with aqueous and acidic (pH < 4.5) foods.
STERILE EO
STERILE EO designates medical devices sterilised using ethylene oxide (EO) gas. EO sterilisation is a low-temperature process suitable for heat-sensitive materials such as plastics and polymers. The symbol is standardised in ISO 15223-1. The sterility assurance level (SAL) of validated EO processes is typically 10⁻⁶.
STERILE R
STERILE R designates medical devices sterilised by ionising radiation – typically gamma radiation (Co-60) or electron beam. The process is governed by ISO 11137 and achieves a sterility assurance level (SAL) of 10⁻⁶. It is suited to single-use articles, plastics, and pre-packaged products, and leaves no chemical residues.