Resumen
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 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.
ISO 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.
Informaciones generales
-
Estado: RetiradaFecha de publicación: 2006-04Etapa: Retirada de la Norma Internacional [95.99]
-
Edición: 1Número de páginas: 37
-
Comité Técnico :ISO/TC 198ICS :11.080.01
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
-
Ahora
-
00
Preliminar
-
10
Propuesta
-
20
Preparación
-
30
Comité
-
40
Consulta
-
50
Aprobación
-
60
Publicación
-
90
Revisión
-
95
Retirada
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.RetiradaISO 11137-1:2006/Amd 1:2013
RetiradaISO 11137-1:2006/Amd 2:2018
-
00
-
Revisada por
PublicadoISO 11137-1:2025