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What Is ISO13485
- Sep 13, 2018 -

Accoring to the Wiki:

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms.

The current ISO 13485 effective edition was published on 1 March 2016.

It's a new rule for Medical Devices, Which is Separated from ISO9001. 

As far as we know, The ISO9001 is still Ok for us to export the bottles to Europe. But with time goes by, ISO13485 probably would be necessary.