Standard

ISO/DIS 16671

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Note: Latest version: ISO 16671:2015

Existing or new amendments and versions must be purchased separately.

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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.

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Standard from ISO
Period for objection until: February 29 2024
Edition: 3
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.70
International TC: ISO/TC 172/SC 7

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Revises: ISO 16671:2015

ISO/DIS 16671

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ISO 16671:2015

ISO 16671:2003

Abstract

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Product life cycle

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ISO 16671:2015

ISO 16671:2003

Abstract

Products specifications

Product Relations

Product life cycle