Standard

ISO 16671:2015

Current

Note: Now under development: ISO/DIS 16671

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.

Products specifications

  • Standard from ISO
  • Published:
  • Edition: 2
  • Document type: IS
  • Pages
  • Publisher: ISO
  • Distributor: ISO
  • ICS: 11.040.70
  • International TC: ISO/TC 172/SC 7

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