Recognized standard
23500-4 First edition 2019-02 23500-4:2019
FDA recognition 9-136 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-136 |
|---|---|
| Designation | 23500-4 First edition 2019-02 23500-4:2019 |
| Title | Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates 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 requirements for concentrates used for haemodialysis and related therapies. This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the… |
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: