Resumen
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2021-11Etapa: Norma Internacional publicada [60.60]
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Edición: 4Número de páginas: 48
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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 10993-10:2010
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Ahora