Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023); German and English version prEN ISO 16671:2023
Abstract
This document specifies 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.
Begin
2023-02-13
WI
00170318
Planned document number
DIN EN ISO 16671
Project number
02703395
Responsible national committee
NA 027-01-20 AA - Intraocular medical devices
Responsible european committee
CEN/TC 170 - Ophthalmic optics
Responsible international committee
ISO/TC 172/SC 7/WG 7 - Ophthalmic implants
draft standard
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023); German and English version prEN ISO 16671:2023
2024-01
Order from DIN Media
