ISO 16671:2015
2015-08
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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Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2017
Next version under development
ISO/DIS 16671
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
Amendments
Provide additional content; Available for purchase; Not included in the text of the existing standard.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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