Is EN ISO 10079-1 same as YY 0636.1? (Medical Suction Equipment)

M

michaelpui

#1
we are looking for a product import to EU, but the manufacturer applied YY 0636.1 and they claimed that TUV accepted both standards are same and issued CE to them.

however, this is funny because they come from different countries.

what do you think?
Thanks for the help!
 
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S

SteveK

#2
Without getting a copy of YY 0636.1 (there appears to be an English version), references to the Chinese Standard indicates that ISO10079-1 is the ?Adopted Standard?. So it is likely that it is basically a facsimile of ISO 10079-1 to fit into a Chinese format and therefore both Standards are probably equivalent (from a NB perspective).

Look at the Information Documents in:

http://www.imdrf.org/documents/documents.asp

That's my best shot!

Steve
 
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