DIN EN ISO 14937:2010-03
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
| Fecha edición: |
2010-03-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation, and routine monitoring and control of a sterilization process for medical devices. |
| Keywords: | Agents|CE marking|Characterisations|Definitions|Developments|Gamma-radiation|Health protection|Hygiene|Inspection|Ionizing radiation|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Methods|Processes|Qualifications|Quality assurance systems|Radiation|Specification|Specification (approval)|Sterilization (birth control)|Sterilization by irradiation|Sterilization (hygiene)|Sterilizers|Sterilizing apparatus|Surveillance (approval)|Use|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 14937:2009 Idéntica ISO 14937:2009 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 14937:2001-05 Reemplaza a DIN EN ISO 14937:2008-01 Reemplaza a DIN EN ISO 14937 Berichtigung 1:2005-06 |










