Recognized standard
60601-2-16 Edition 5.0 2018-4 60601-2-16:2018
FDA recognition 9-121 · IEC · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-121 |
|---|---|
| Designation | 60601-2-16 Edition 5.0 2018-4 60601-2-16:2018 |
| Title | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | The testing in this standard applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16 testing does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis… |
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: