info@calibeur.com
86-755-26010950
Home  >  FAQ  >  What's ISO13485?

What's ISO13485?

2015/06/08

 ISO13485 is short name for Medical device-Quality management system-requirements for regulatory. As  medical devices are special products for life-saving and disease prevention ,only general requirements according to ISO9000 standards  is not enough, so ISO organization issued the ISO13485 ISO: 1996 version  (YY / T0287 and YY / T0288),