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medical instruments

Countermeasures for CE certification adoption about electronic non-invasive blood pressure measuring device


EN 1060 series standard of the old edition still applied due to the 80601-2-30 criteria for EN haven’t been published on Official Journal of the European union. When CE is registered, the standard test combination currently applicable is as follows:
 
The following social criteria currently apply to the textile processing level.
 
The common criterias and specialized standards applied to electronic sphygmomanometer and blood pressure monitoring devices?based on Measure principle on oscillametric method
 
standard type Adopting old standard Adopting new standard
Common Criteria EN 60601-1:1990/A1:1993/A2:1995 EN 60601-1:2006 / A11:2011
Specialized Standard EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
ISO 81060-1:2007
Criteria for Home Medical Equipment Non IEC 60601-1-11:2010 + Corr.1:2011
EN 60601-1-11:2010
Clinical criteria of blood pressure EN 1060-4:2004 ISO 81060-2:2009
 
 
The common criterias and specialized standards applied to electronic sphygmomanometer and blood pressure monitoring devices?based on Measure principle on oscillametric method
 
standard type Adopting old standard Adopting new standard
Common Criteria EN 60601-1:1990/A1:1993/A2:1995 IEC 60601-1:2005 + Corr.1:2006+Corr.2:2007
EN 60601-1:2006/A11:2011
Specialized Standard EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-2-30:2000
ISO 81060-1:2007
Clinical criteria of blood pressure EN 1060-4:2004 ISO 81060-2:2009
 
 
Recommend for manufacturers:Testing by new standard.