SS-EN-ISO-16672 › Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
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This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and efficacy of OE, this document 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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Designation Name
SS-EN ISO 16672:2021
Revision Level
2021 EDITION
Status
Current
Publication Date
Oct. 18, 2021
Language(s)
English
Page Count
28
International Equivalent
EN ISO 16672:2021(IDT); ISO 16672:2020(IDT)