ISO 10993-4:2017
2017-04
Resumen
ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.
It describes
a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2017-04Etapa: Norma Internacional para revisar [90.92]
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Edición: 3Número de páginas: 69
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Comité Técnico :ISO/TC 194ICS :11.100.20
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Ciclo de vida
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Anteriormente
RetiradaISO 10993-4:2002
RetiradaISO 10993-4:2002/Amd 1:2006
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Ahora
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00
Preliminar
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10
Propuesta
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20
Preparación
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30
Comité
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40
Consulta
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50
Aprobación
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60
Publicación
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90
Revisión
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95
Retirada
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.En desarrolloISO 10993-4:2017/PRF Amd 1
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00
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Será reemplazada por
En desarrolloISO/AWI 10993-4
