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prEN ISO 16671

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023)

General information
Draft
Base Documents
ISO/DIS 16671; prEN ISO 16671
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 16671
01.12.2017
Amendment
06.10.2015
Main
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.
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