NON STERILE
The NON STERILE designation on a medical device indicates that the product has not been sterilised and is not supplied with a sterility guarantee. Under MDR (EU) 2017/745 and ISO 15223-1, the sterility status must be declared on the label.
NON STERILE is the counterpart to designations such as STERILE, STERILE EO (ethylene oxide sterilisation), and STERILE R (radiation sterilisation). It is the most common sterility status for examination gloves (EN 455) and other general-use single-use products.
Non-sterile medical examination gloves are suitable for routine patient examinations and general clinical contact but are not intended for invasive surgical procedures. Sterile surgical gloves, by contrast, are individually packaged with a sterility assurance level (SAL) of 10⁻⁶.
In procurement, distinguishing between sterile and non-sterile products is critical: sterile products are supplied in sealed individual packaging with sterilisation validation documentation; non-sterile products are typically supplied in dispensing boxes or bulk packaging.
Frequently asked questions
What does NON STERILE mean on medical gloves?
NON STERILE means the gloves have not been sterilised and are not supplied with a sterility guarantee. They are suitable for routine examinations but not for sterile surgical procedures.
What is the difference between NON STERILE and STERILE?
STERILE means the product has been sterilised under validated conditions and is delivered germ-free with a defined sterility assurance level. NON STERILE means no such guarantee is provided.
Can NON STERILE products be sterilised before use?
In principle yes, but sterilisation must be carried out under validated conditions and must not alter the product's properties. Post-market sterilisation by a healthcare facility creates new regulatory obligations for the reprocessor.