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.
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.
WITHDRAWN
SRPS EN ISO 16671:2012
WITHDRAWN
SRPS EN ISO 16671:2016
95.99
Withdrawal of Standard
Mar 31, 2026
PUBLISHED
SRPS EN ISO 16671:2026