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

For non-invasive blood pressure measurements, the results of the FDA product code are as follows: 
 
 

Device	system, measurement, blood-pressure, non-invasive
Regulation Description	Noninvasive blood pressure measurement system.
Regulation Medical Specialty	Cardiovascular
Review Panel	Cardiovascular
Product Code	DXN
Submission Type	510(k)
Regulation Number	870.11306
Device Class	2
Total Product Life Cycle (TPLC)	TPLC Product Code Report7
GMP Exempt?	No
Recognized Consensus Standards SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers8 AAMI/ANSI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers9 AAMI/ANSI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type10 ·         ISO 81060-2 First edition 2009-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type11

 

Since FDA is currently not enforce the Common Criteria of 3^rd edition, the reports based on old Specialized Standards（ANSI/AAMI SP10）and Common Criteria(2^nd edition) for electronic sphygmomanometers or blood pressure monitoring devices are still acceptable before 30 June, 2013.
The standard test combinations currently applicable are as follows:
Universal and special standards for electronic sphygmomanometers and blood pressure monitoring devices based on the principle of oscillating measurement

standard type	Adopting old standard	Adopting new standard
Common Criteria	IEC 60601-1:1988/A1:1991/A2:1995	IEC 60601-1:2005
Specialized Standard+ Clinical demand	ANSI/AAMI SP10:2002/ A2:2006/(R)2008	AAMI/ANSI/IEC 80601-2-30:2009 AAMI/ANSI/ISO 81060-2:2009

 
 
Recommend for manufacturers：Testing by new standard.
 
Since 30 June 2013，ANSI/AAMI SP10 will be replaced by ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009 and ANSI/AAMI/IEC 80601-2-30:2009, Reports based on ANSI/AAMI SP10 will not be accepted.
 
 
 
For non-invasive blood pressure measurements, the results of the FDA product code are as follows: 
 

Device	system, measurement, blood-pressure, non-invasive
Regulation Description	Noninvasive blood pressure measurement system.
Regulation Medical Specialty	Cardiovascular
Review Panel	Cardiovascular
Product Code	DXN
Submission Type	510(k)
Regulation Number	870.11306
Device Class	2
Total Product Life Cycle (TPLC)	TPLC Product Code Report7
GMP Exempt?	No
Recognized Consensus Standards SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers8 AAMI/ANSI/IEC 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers9 AAMI/ANSI/ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type10 ·         ISO 81060-2 First edition 2009-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type11

 
Since the FDA has not yet begun to enforce the third version of the standard, before June 30, 2013, for the electronic sphygmomanometer or blood pressure monitoring equipment, the old version of the standard (ANSI/AAMI SP10) and the standard (2nd) The report) is accepted.
 
The standard test combinations currently applicable are as follows:
Universal and special standards for electronic sphygmomanometers and blood pressure monitoring devices based on the principle of oscillating measurement

Standard type	Adopting the old standard	Adopt new version of the standard
General standard	IEC 60601-1:1988/A1:1991/A2:1995	IEC 60601-1:2005
Special standard + Clinical requirements	ANSI/AAMI SP10:2002/ A2:2006/(R)2008	AAMI/ANSI/IEC 80601-2-30:2009 AAMI/ANSI/ISO 81060-2:2009

 
 
Recommendation: Manufacturers use the new standard for testing.
After June 30, 2013，ANSI/AAMI SP10 will be replaced by the standard ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009 and ANSI/AAMI/IEC 80601-2-30:2009, the ANSI/AAMI SP10 report will be rejected.