Blood Pressure
Regulatory Validation Testing
Validation with Non-invasive (Auscultatory) Reference
Sphygmomanometer: (ISO 81060-2,
ANSI/AAMI SP10, FDA)
Studies conducted to meet the requirements for Non-automated or
Automated Blood pressure
measurement comparisons to reference,
non-invasive sphygmomanometers
● Adults, pediatrics and infants
Validation with Reference
Invasive Blood Pressure Monitoring Equipment: (ISO 81060-2,
ANSI/AAMI SP10, FDA)
Studies conducted to meet the requirements for Non-automated or
Automated Blood pressure
measurement comparisons to reference, invasive
arterial blood pressure
● Adults, pediatrics (future offering) and
infants (future offering)
CLINIMARK Blood Pressure
studies & PROTOCOLS are registered with
ClinicalTrials.gov
and MEET OR EXCEED ALL REGULATORY STANDARD
REQUIREMENTS INCLUDING:
ANSI/AAMI SP10, ISO 81060 (2009), FDA GUIDANCE DOCUMENTS, MDD, ASTM,
IEC, BHA
