March 9, 2018
Every GOST R is a National Standard but not every National Standard is GOST R
Dear colleagues, in this article we give to you the explanation about reasons of using standards of GOST range during the procedure of obtaining registration certificates for medical devices.
The interested sites may have a question: "Must my device comply with National Russian Standards GOST R XXXXX-XXXX, but also with EAC standards with the GOST XXXXX-XXXX, if I would like to get the State Registration for this only in Russia?".
The answer is very simple.
Over time every Standard gets older. Of course, National Standards of Russian Federation too. And some of these standards are replaced with actual editions of GOST XXXXX-XXXX standards, which become the status of National Standards of Russian Federation.
Let's examine some popular examples of that standards:
|
Replaceable GOST R Standard |
Replacing GOST Standard |
|
GOST R ISO 11135-2000 |
GOST ISO 11135-2012 |
|
GOST R ISO 11137-1-2008 |
GOST ISO 11137-1-2011 |
|
GOST R ISO 13485-2004 |
GOST ISO 13485-2011 |
|
GOST R ISO 14971-2009 |
GOST ISO 14971-2011 |
|
GOST R ISO 10993 range |
GOST ISO 10993 range |
|
GOST R ISO 7864-2009 |
GOST ISO 7864-2011 |
|
GOST R ISO 7886-1-2009 |
GOST ISO 7886-1-2011 |
So we hope, that this information will be useful for your understanding of the procedure of State Registration of medical devices.
