Resumen
This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2025-06Etapa: Norma Internacional publicada [60.60]
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Edición: 3Número de páginas: 26
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Comité Técnico :ISO/TC 172/SC 7ICS :11.040.70
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Ciclo de vida
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Anteriormente
RetiradaISO 16671:2015
RetiradaISO 16671:2015/Amd 1:2017
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Ahora
