Standard Swedish standard · SS-EN ISO 15798:2022

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)

Status: Valid

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Standard Swedish standard · SS-EN ISO 15798:2022

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
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Scope
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.
This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Subjects

Ophthalmic equipment (11.040.70)


Buy this standard

Standard Swedish standard · SS-EN ISO 15798:2022

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
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
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80033782

Edition: 4

Approved: 2/14/2022

No of pages: 32

Replaces: SS-EN ISO 15798:2013 , SS-EN ISO 15798:2013/A1:2017