Recognized standard
23500-5 First edition 2019-02 23500-5:2019
FDA recognition 9-137 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-137 |
|---|---|
| Designation | 23500-5 First edition 2019-02 23500-5:2019 |
| Title | Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document excludes… |
At a glance
- 10–99 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: