Wagner Sterilsysteme

Background

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	Reaching Sterility	Requirements
		STERILE is defined in international standards as "Condition of a medical device that is free from viable microorganism". In order to reach that state, medical devices must be cleaned and TERMINALLY STERILIZED (term for medical devices which have been sterilized after being completely sealed or enclosed in at least the primary (barrier) package...)

	Load / packaging / sterilization cycle compatible ?	It is important to understand that there is NO universally applicable method to TERMINALLY STERILIZE a packaged medical device: different sterilization methods / principles / cycle designs are available, but each of them has RESTRICTIONS, can so not be applied to all devices / packages modern medical equipment is no longer "simple stainless steel" but can be formed of a variety of different materials and designs (MIS-instruments; optics; high density equipment like drilling machines...) : depending from the device, a suitable sterilization method / packaging must de selected different packaging materials / systems are available, offering different levels of protection - but also different sterilization compatibility...
	Validation required...	As a specific application (specific device in a specific packaging, exposed to a specific sterilization cycle in the individual hospital) may be unique in a specific hospital, regulations require that the HOSPITAL USER needs to validate sterilization compatibility of this combination.