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EVS-EN ISO 16671:2015

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

General information
Valid from 06.10.2015
Base Documents
ISO 16671:2015; EN ISO 16671:2015
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN ISO 16671
01.12.2017
Amendment
06.10.2015
Main
10.03.2004
Main
This International Standard 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.
This International Standard 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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