BS EN ISO 16672:2021 - TC

This standard BS EN ISO 16672:2021 - TC Tracked Changes. Ophthalmic implants. Ocular endotamponades is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

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.