Recognized standard
27185 First edition 2012-02-15 27185:2012
FDA recognition 3-132 · ISO · Cardiovascular
Key facts
| Recognition number | 3-132 |
|---|---|
| Designation | 27185 First edition 2012-02-15 27185:2012 |
| Title | Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General… |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jun 15, 2016 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011. ISO 27185:2011 is applicable to, and limited to… |
At a glance
- 10–99 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: