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.
General information
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Status: PublishedPublication date: 2015-08Stage: International Standard to be revised [90.92]
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Edition: 2Number of pages: 22
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Technical Committee :ISO/TC 172/SC 7ICS :11.040.70
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Life cycle
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Previously
WithdrawnISO 16671:2003
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Corrigenda / Amendments
PublishedISO 16671:2015/Amd 1:2017
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00
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Will be replaced by
Under developmentISO/DIS 16671
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