Recognized standard
80601-2-78 Edition 1.0 2019-07
FDA recognition 16-232 · IEC · Physical Medicine
Key facts
| Recognition number | 16-232 |
|---|---|
| Designation | 80601-2-78 Edition 1.0 2019-07 |
| Title | Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Physical Medicine |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT'S MOVEMENT… |
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: