Recognized standard
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
FDA recognition 19-49 · IEC · General II (ES/EMC)
Key facts
| Recognition number | 19-49 |
|---|---|
| Designation | 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General II (ES/EMC) |
| Date of entry | Apr 3, 2023 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME… |
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: