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About This Item

 

Full Description

BS EN 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.

This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.


Cross References:
ISO 10993-1:2009
ISO 10993-2:2006
ISO 11607-1:2006
ISO 13408-1:2008+Amd.1:2013
ISO 14155:2011
ISO 14630:2012
ISO 14971:2007
ISO 15223-1:2012
ISO 22442-1:2007
EN 1041:2008+A1:2013
93/42/EEC
ISO 10993-7:2008
AAMI TIR No.19:1998
ISO 10993-6:2007


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 16671:2015+A1:2017


    Ophthalmic implants. Irrigating solutions for ophthalmic surgery

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  2. BS EN ISO 16671:2015

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    Ophthalmic implants. Irrigating solutions for ophthalmic surgery

    • Historical Version
  3. BS EN ISO 16671:2003


    Ophthalmic implants. Irrigating solutions for ophthalmic surgery

    • Historical Version