Recognized standard
60601-2-6 Edition 2.1 2016-04
FDA recognition 6-423 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-423 |
|---|---|
| Designation | 60601-2-6 Edition 2.1 2016-04 |
| Title | CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 60601-2-6:2012+A1:2016 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels… |
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: