Recognized standard
81060-1 First edition 2007-12-01 81060-1:2007/(R)2013
FDA recognition 3-96 · ISO · Cardiovascular
Key facts
| Recognition number | 3-96 |
|---|---|
| Designation | 81060-1 First edition 2007-12-01 81060-1:2007/(R)2013 |
| Title | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation. ISO 81060-1:2007 specifies requirements for the safety and essential performance… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: