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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
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.Note Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

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:

Equivalencia Internacional

Idéntica EN ISO 14937:2009

Idéntica ISO 14937:2009

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

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