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Clinical evaluation of the performance of Bionet sphygmomanometer modules based on protocol presented by the International Organization for Standardization

Clinical evaluation of Bionet sphygmomanometer module BN1 based on ISO 81062-2:2018 protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005090
Enrollment
102
Registered
2020-06-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive memoryomers- P

Sponsors

Hanyang University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects presented in ISO 81062-2:2018 Protocol

Exclusion criteria

Exclusion criteria: Emergency surgery patient Persons who have mental disorders such as mental retardation, autism, etc. and who have difficulty measuring blood pressure or are expected to have difficulties A person who disagreed with the study

Design outcomes

Primary

MeasureTime frame
Test device's blood pressure of resting condition

Secondary

MeasureTime frame
Stethoscope's blood pressure of resting condition

Countries

Korea, Republic of

Contacts

Public ContactYOUNGHEE LIM

Hanyang University Seoul Hospital

younghee1165@hanyang.ac.kr+82-2-2220-4979

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026