Resumen
ϲʿ 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ϲʿ 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ϲʿ 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ϲʿ 11137-1:2006 does not:
- specify requirements for 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;
- detail specified requirements for designating a medical device as sterile;
- specify a quality management system for the control of all stages of production of medical devices;
- specify requirements for occupational safety associated with the design and operation of irradiation facilities;
- specify requirements for the sterilization of used or reprocessed devices.
Modificaciones
Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.
Ciclo de vida
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Anteriormente
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Ahora
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.Publicadoϲʿ 11137-1:2006/Amd 1:2013
Publicadoϲʿ 11137-1:2006/Amd 2:2018
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Será reemplazada por
En desarrolloϲʿ/FDIS 11137-1
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