Recognized standard
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION
FDA recognition 5-132 · IEC · General I (QS/RM)
Key facts
| Recognition number | 5-132 |
|---|---|
| Designation | 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses… |
At a glance
- None 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: