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immediate downloadReleased: 2021-10-14
BS EN ISO 16672:2021
Ophthalmic implants. Ocular endotamponades
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Standard number: | BS EN ISO 16672:2021 |
Pages: | 24 |
Released: | 2021-10-14 |
ISBN: | 978 0 580 95003 2 |
Status: | Standard |
DESCRIPTION
BS EN ISO 16672:2021
This standard BS EN ISO 16672:2021 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.