Recognized standard
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 60601-1-8:2006 and A1:2012 [Including AMD 2:2021]
FDA recognition 5-131 · IEC · General I (QS/RM)
Key facts
| Recognition number | 5-131 |
|---|---|
| Designation | 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
| Title | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Medical Electrical Equipment - Part 1-8: General… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 21, 2020 |
| 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. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT… |
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: