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SRPS EN ISO 16671:2016

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

Aug 30, 2016
95.99   Withdrawal of Standard   Mar 31, 2026

General information

95.99     Mar 31, 2026

ISS

Z172

European Norm

11.040.70  

English  

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 16671:2012

NOW

WITHDRAWN
SRPS EN ISO 16671:2016
95.99 Withdrawal of Standard
Mar 31, 2026

REVISED BY

PUBLISHED
SRPS EN ISO 16671:2026

Related project

Adopted from EN ISO 16671:2015

Adopted from ISO 16671:2015