Medical classification and uses
ENBIO sterilizers perform sterilization processes in class B and class S, they are small-sized steam sterilizers class B in accordance with EN 13060, classified as a class IIb medical device, in accordance with Annex IX of Directive 93/42 / EEC on medical devices and the Regulation of the Minister of Health of 5 November 2010 on the method of classifying medical devices.
According to the classification of standard 13060, ENBIO devices can sterilize medical devices : solid loads, small porous items, small porous loads, full porous loads, simple hollow items, narrow lumen items, packaging multiple, which can be unpackaged or wrapped (single and multi-layer). The sterilizers have a medical device certificate, meet 100% sanepid requirements and provide a guarantee of safety and protection against any infections.
Process 134 FAST is dedicated to solid, non-porous instruments, simple instruments and dental tools (e.g. scissors, handles, pliers, chisels, probes, etc.) only unwrapped, not textile.
The ENBIO S and ENBIO PRO devices can be used in primary health care practices, in dental practices, and in treatment rooms. The sterilizer is designed to work in the vicinity of other electrical medical devices.
The ENBIO S and ENBIO PRO devices can also be used for non-medical applications, e.g. in beauty and wellness salons, and in veterinary practices, beauty salons, tattoo studios, piercings and hairdressing salons.
The steam steriliser has been successfully used for sterilization: