Recognized standard
23500-4 Second edition 2024-04
FDA recognition 9-155 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-155 |
|---|---|
| Designation | 23500-4 Second edition 2024-04 |
| 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 | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates. This document is applicable to: - concentrates in both liquid and powder forms; - additives, also called spikes… |
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: