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DIN EN ISO 20857:2013-08

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013

Fecha edición: 2013-08-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. This International Standard specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This International Standard does not apply to processes that use infrared or microwaves as the heating technique. This International Standard does not detail a specified requirement for designating a medical device as "sterile". This International Standard does not specify a quality management system for the control of all stages of production of medical devices. This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities.
Keywords: Checks|Control method|Control test|Definitions|Developments|Dry heat|Dry-heat tests|Industrial|Medical devices|Medical products|Medical sciences|Processes|Public health|Quality management|Quality requirements|Routine tests|Safety requirements|Specification (approval)|Sterile technology|Sterilization (hygiene)|Validation
ICS: 11.080.01 - Esterilización y desinfeccion en general
CTN:

Equivalencia Internacional

Idéntica EN ISO 20857:2013

Idéntica ISO 20857:2010

Reemplazo Normas

Reemplaza a DIN EN ISO 20857:2012-10

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