Recognized standard
/TS 81060-5 First edition 2020-02
FDA recognition 3-167 · ISO · Cardiovascular
Key facts
| Recognition number | 3-167 |
|---|---|
| Designation | /TS 81060-5 First edition 2020-02 |
| Title | Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only. In addition, the pulse rate set on the NIBP simulator is tested. This… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: