DIN EN ISO 13004:2023-10
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO 13004:2022); German version EN ISO 13004:2023
| Fecha edición: |
2023-10-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10?6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. The responsible national standards body is the working committee NA 176-03-09 AA "Sterilization and reprocessing of medical devices" in the DIN Standards Committee on Health Technologies (NAGesuTech). This document is the adoption of a published ISO standard for the development of Annex ZA for conformity to the Medical Devices Regulation. |
| Keywords: | Acceptance (approval)|Biological hazards|Containers|Definitions|Dose|Dosimeters|Dosimetry|Efficiency|Electron beams|Gamma-radiation|Germicides|Health protection|Hygiene|Inspection|Ionizing radiation|Irradiation apparatus|Maintenance|Medical devices|Medical equipment|Medical sciences|Medical technology|Phototherapy|Public health|Radiation|Ray treatment|Specification (approval)|Sterilization by irradiation|Sterilization (hygiene)|Surveillance (approval)|X-rays |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 13004:2023 Idéntica ISO 13004:2022 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 13004:2023-03 Reemplaza a DIN CEN ISO/TS 13004:2014-10;DIN SPEC 13223:2014-10 |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
