Publikuar
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.
Revises
ISO 16671:2003
PUBLISHED
ISO 16671:2015
90.92
Standard to be revised
21 pri 2022
Amended by
ISO 16671:2015/Amd 1:2017
IN_DEVELOPMENT
ISO/DIS 16671.2
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