DIN 58953-6:2025-03
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
| Fecha edición: |
2025-03-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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). |
| Keywords: | Compactness|Germs|Medical equipment|Medical sciences|Moisture|Packages|Packaging material|Packaging processes|Packaging tests|Sampling methods|Specification (approval)|Steam sterilization|Sterile equipment|Sterile supply|Sterilization (hygiene)|Sterilized goods|Strength of materials|Testing|Tightness |
| ICS: | 11.080.30 - Envases estériles |
| CTN: | |
|
Reemplazo Normas |
Reemplaza a DIN 58953-6:2023-11 |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
