prBAS EN ISO 16671:2027
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
General information
Status:Project
Number of pages:29
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:22.10.2026
Forseen date for next stage code:31.10.2026
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.70, Ophthalmic equipment
Abstract
This document 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 document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
Lifecycle
...
Original document and degree of correspondence
EN ISO 16671:2025, identical
ISO 16671:2025, identical
Relation to BAS standards
Work material
Only members of the technical committee have access to work material. If you are a members of this technical committee you need to login to view the documents. Login