EN ISO 16671:2015

Name: EN ISO 16671:2015
Brand: CEN
SKU: EN ISO 16671:2015
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Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) EN ISO 16671:2015

Publication date: Nov 16, 2015

General information

Current stage: 60.60 Standard published Aug 26, 2015

Originator: CEN

Owner: CEN/TC 170 Ophthalmic optics

Type: European Norm

ICS: 11.040.70 Ophthalmic equipment

Buying

Status: Published

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

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WITHDRAWN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
prEN ISO 16671