Abstract

This document specifies requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Begin

2023-02-13

WI

00170318

Planned document number

DIN EN ISO 16671

Project number

02703395

Responsible national committee

NA 027-01-20 AA - Intraocular medical devices  

Responsible european committee

CEN/TC 170 - Ophthalmic optics  

Responsible international committee

ISO/TC 172/SC 7/WG 7 - Ophthalmic implants  

draft standard

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023); German and English version prEN ISO 16671:2023
2024-01
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Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671.2:2024); German and English version prEN ISO 16671:2024
2024-10
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previous edition(s)

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017); German version EN ISO 16671:2015 + A1:2017
2018-03

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