Recognized standard
80601-2-13 First edition 2011-08-11
FDA recognition 1-141 · ISO · Anesthesiology
Key facts
| Recognition number | 1-141 |
|---|---|
| Designation | 80601-2-13 First edition 2011-08-11 |
| Title | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic… |
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: