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ISO 16671:2015

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ISO 16671:2015

Ophthalmic implants — Irrigating solutions for ophthalmic surgery

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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.

Author ISO/TC 172/SC 7 Ophthalmic optics and instruments
Editor ISO
Document type Standard
Format Paper
Edition 2
ICS 11.040.70 : Ophthalmic equipment
Number of pages 22
Replace ISO 16671:2003
Modified by ISO 16671:2015/Amd 1:2017
Weight(kg.) 0.1374
Year 2015
Country Switzerland