Recognized standard
23500-1 Second edition 2024-08
FDA recognition 9-152 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-152 |
|---|---|
| Designation | 23500-1 Second edition 2024-08 |
| Title | Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 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 general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's… |
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: