Resumen
ISO 15798:2010 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2010 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.
Informaciones generales
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Estado: RetiradaFecha de publicación: 2010-02Etapa: Retirada de la Norma Internacional [95.99]
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Edición: 2Número de páginas: 16
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Comité Técnico :ISO/TC 172/SC 7ICS :11.040.70
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 15798:2001
RetiradaISO 15798:2001/Cor 1:2003
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Ahora
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Revisada por
RetiradaISO 15798:2013
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