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EN ISO 16671:2015

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) EN ISO 16671:2015

Publication date:   Nov 16, 2015

General information

60.60 Standard published   Aug 26, 2015

CEN

CEN/TC 170 Ophthalmic optics

European Norm

11.040.70   Ophthalmic equipment

Buying

Published

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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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 16671:2003

NOW

PUBLISHED
EN ISO 16671:2015
60.60 Standard published
Aug 26, 2015

CORRIGENDA / AMENDMENTS

PUBLISHED
EN ISO 16671:2015/A1:2017

REVISED BY

IN_DEVELOPMENT
FprEN ISO 16671