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Medical device
Current location: Home > Detection service > Medical device

Detection service / CE certification of electronic non-invasive blood pressure measuring equipment

Since the OJ website of the European Union has not yet published the standard for the conversion to EN 80601-2-30, the old version of the EN 1060 series standard still applies. CE registration, the currently applicable standard test combination, refer to the following:
 
General standard and specific standard for electronic sphygmomanometer based on the measurement principle of oscillation method
Standard type
Old standard
Adopt the new standard
General standard
EN 60601-1:1990/A1:1993/A2:1995
EN 60601-1:2006 / A11:2011
Special standard
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
ISO 81060-1:2007
Standard for household medical devices
None
IEC 60601-1-11:2010 + Corr.1:2011
EN 60601-1-11:2010
Blood pressure clinical criteria
EN 1060-4:2004
ISO 81060-2:2009
 
General standard and specific standard for blood pressure monitoring equipment based on the principle of oscillation method
Standard type
Old standard
Adopt the new standard
General standard
EN 60601-1:1990/A1:1993/A2:1995
IEC 60601-1:2005 + Corr.1:2006+Corr.2:2007
EN 60601-1:2006/A11:2011
Special standard
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-2-30:2000
ISO 81060-1:2007
Blood pressure clinical criteria
EN 1060-4:2004
ISO 81060-2:2009
 
Recommended: Manufacturers use the new version of the standard for testing.

 
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