EN ISO 16671:2015

Name: EN ISO 16671:2015
Brand: CEN
SKU: EN ISO 16671:2015
Price: 56.1 EUR
Availability: InStock
Rating: 5 (95 reviews)

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

Publication date: Nov 16, 2015

General information

Current stage: 99.60 Withdrawal effective Jun 18, 2025

Originator: CEN

Owner: CEN/TC 170 Ophthalmic optics

Type: European Norm

ICS: 11.040.70 Ophthalmic equipment

Buying

Status: Withdrawn

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WITHDRAWN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

WITHDRAWN
EN ISO 16671:2015
99.60 Withdrawal effective
Jun 18, 2025

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 16671:2015/A1:2017

REVISED BY

PUBLISHED
EN ISO 16671:2025