Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Prenumerera på standarder med tjänst SIS Abonnemang. Genom att prenumerera får du effektiv åtkomst till gällande standarder och säkerställer att ditt företag alltid har tillgång till senaste utgåvan.
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The "Sterile Supply" series of standards describes parts of the reprocessing of medical devices that are carried out in units such as the "Reprocessing Unit for Medical Devices" (AEMP). The AEMP is usually separated into the cleaning and disinfection area, the packaging area and the sterile supply area. General requirements for packaging for medical devices to be sterilized in the final packaging, including validation requirements for processes of forming, sealing and assembling, are specified in the DIN EN ISO 11607 series of standards. In addition, the DIN EN 868 series of standards contains test methods and values for specific materials for prefabricated sterile barrier systems and for packaging systems intended to maintain the sterility of the medical devices to be sterilized in the final packaging until the time of use. DIN 58953-6 specifies test methods for the determination of germ tightness in the presence of moisture and in the presence of air. These test methods are applicable to packaging materials for medical devices to be sterilised. DIN 58953-6 was prepared by the working committee NA 176-03-07 AA "Sterile Supply" in the DIN Standards Committee for Health Technologies (NAGesuTech).
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
Prenumerera på standarder med tjänst SIS Abonnemang. Genom att prenumerera får du effektiv åtkomst till gällande standarder och säkerställer att ditt företag alltid har tillgång till senaste utgåvan.
Läs mer om SIS Abonnemang
Internationell titel: Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized