Recognized standard
80601-2-70 First Edition 2015-01-15
FDA recognition 1-115 · ISO · Anesthesiology
Key facts
| Recognition number | 1-115 |
|---|---|
| Designation | 80601-2-70 First Edition 2015-01-15 |
| Title | Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment |
| Standards developer | International Organization for Standardization |
| Specialty area | Anesthesiology |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 80601-2-70:2015 is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as me equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure… |
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: