Recognized standard
60601-2-39 Edition 3.0 2018-04
FDA recognition 9-149 · IEC · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-149 |
|---|---|
| Designation | 60601-2-39 Edition 3.0 2018-04 |
| Title | Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment… |
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: