BS EN ISO 16671:2015+A1:2017 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 15223-1:2012 ED2
ISO 11607-1:2006 (R10) Ed 1
ISO 14630:2012
ISO 22442-1:2015
ISO 13408-1:2008/AMD 1:2013
ISO 13408-1:2008
ISO 10993-1:2009
ISO 14971:2007
ISO 10993-2:2006
ISO 14155:2011
EN 1041:2008+A1:2013
AAMI TIR 19:1998
ISO 10993-6:2007
ISO 10993-7:2008
Incorporates the following:Amendment, January 2018
| File Size : | 1
file
, 1000 KB |
| ISBN(s) : | 9780580963858 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 32 |
| Product Code(s) : | 30351469, 30351469, 30351469 |
| Published : | 01/12/2018 |
