NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671.2:2024)

Abstract

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.

Begin

2023-02-05

WI

00170318

Planned document number

prEN ISO 16671

Responsible national committee

NA 027-01-20 AA - Intraocular medical devices  

Responsible european committee

CEN/TC 170 - Ophthalmic optics  

previous edition(s)

Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)
2017-11

Order from DIN Media

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
2015-08

Order from DIN Media

Contact

Jalini Mohanarajah

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Tel.: +49 7231 9188-14

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