Standard Swedish standard · SS-EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)

Status: Valid

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Standard Swedish standard · SS-EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
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Scope
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.

Subjects

Ophthalmic equipment (11.040.70)


Buy this standard

Standard Swedish standard · SS-EN ISO 16672:2021

Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Price: 1 620,80 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80031795

Edition: 3

Approved: 10/18/2021

No of pages: 28

Replaces: SS-EN ISO 16672:2015