prEN ISO 16671

Name: prEN ISO 16671
Brand: CEN
SKU: prEN ISO 16671
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Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023) prEN ISO 16671

Publication date: Dec 21, 2023

General information

Current stage: 40.60 Close of voting Mar 15, 2024

Originator: CEN

Owner: CEN/TC 170 Ophthalmic optics

Type: European Norm

ICS: 11.040.70 Ophthalmic equipment

Buying

Status: Draft

Scope

ISO 16671:2015 defines 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.
ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 16671:2015

PUBLISHED
EN ISO 16671:2015/A1:2017

NOW

IN_DEVELOPMENT
prEN ISO 16671
40.60 Close of voting
Mar 15, 2024