Resumen
ISO 16671:2015 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.
ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
Informaciones generales
-
Estado: En desarrolloEtapa: Cierre de la votación [40.60]
-
Edición: 3Número de páginas: 25
-
Comité Técnico :ISO/TC 172/SC 7ICS :11.040.70
- RSS actualizaciones
Ciclo de vida
-
Anteriormente
PublicadoISO 16671:2015
PublicadoISO 16671:2015/Amd 1:2017
-
Ahora