SS-EN-ISO-16671 › Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

SS-EN-ISO-16671 - 2015 EDITION - CURRENT


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Included in this current edition are the following subparts:

 2015 EDITION - Aug. 30, 2015
 2015/A1:2017 EDITION AMENDMENT - Nov. 28, 2017

This International Standard 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 International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

To find similar documents by classification:

11.040.70 (Ophthalmic equipment Including ophthalmic implants, glasses, contact lenses and their cleaning products)


Medical devices

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Designation Name

SS-EN ISO 16671:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

Aug. 30, 2015

Language(s)

English

Page Count

40

International Equivalent

EN ISO 16671:2015(IDT); ISO 16671:2015(IDT)