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ISO 16672:2015

Ophthalmic implants -- Ocular endotamponades

Üldinfo
Kehtetu alates 26.06.2020
Tegevusala (ICS grupid)
11.040.70 Silmaraviseadmed
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
26.06.2020
Põhitekst
07.08.2015
Põhitekst
Põhitekst
ISO 16672:2003
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.
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