Resumen
ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
Informaciones generales
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Estado: RetiradaFecha de publicación: 2015-08Etapa: Retirada de la Norma Internacional [95.99]
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Edición: 2Número de páginas: 13
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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 16672:2003
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Ahora
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Revisada por
PublicadoISO 16672:2020