Abstract

 Preview

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 

  • Status
     : Published
    Publication date
     : 2015-08
  • Edition
     : 2
    Number of pages
     : 22
  • Technical Committee
     : ISO/TC 172/SC 7 Ophthalmic optics and instruments
  • ICS
     :
    11.040.70 Ophthalmic equipment

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This standard contributes to the following Sustainable Development Goals

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