ISO/FDIS 16671

This draft is in the approval phase.

Will replace ISO 16671:2015

Abstract

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.

General information

Status
: Under development

Stage
: Final text received or FDIS registered for formal approval [50.00]
Edition
: 3
Technical Committee :
ISO/TC 172/SC 7

ICS :
11.040.70
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