DIN EN ISO 11737-2:2020-07
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020
| Fecha edición: |
2020-07-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. |
| Keywords: | Bioassay|CE marking|Components|Definitions|Medical devices|Medical equipment|Medical products|Medical sciences|Microbiology|Packages|Quality|Quality management|Raw material|Sterile|Sterility|Sterilization (hygiene)|Testing|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general, 07.100.10 - Microbiología médica |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11737-2:2020 Idéntica ISO 11737-2:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11737-2:2010-04 Reemplaza a DIN EN ISO 11737-2:2018-07 |
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