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About This Item

 

Full Description

BS EN ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.

With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.


Cross References:
ISO 10993-1:2009
ISO 10993-2:2006
ISO 10993-6:2007
ISO 11135-1:2007
ISO 11137-1:2006+Amd.1:2013
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 17665-1:2006
ISO 20857:2010
EN 1041:2008+A1:2013
93/42/EEC


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

Document History

  1. BS EN ISO 16672:2021


    Ophthalmic implants. Ocular endotamponades

    • Most Recent
  2. BS EN ISO 16672:2015

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    Ophthalmic implants. Ocular endotamponades

    • Historical Version
  3. BS EN ISO 16672:2003


    Ophthalmic implants. Ocular endotamponades

    • Historical Version