BAS EN ISO 16671:2016
Oftalmološki implantati - Otopine za ispiranje u oftalmološkoj hirurgiji
Opšte informacije
Status: Važeći
Broj strana: 28
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 18.05.2016
Tehnički komitet:
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 16671:2015, identičan
- ISO 16671:2015, identičan