Recognized standard
23500-1 First edition 2019-02 23500-1:2019
FDA recognition 9-133 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-133 |
|---|---|
| Designation | 23500-1 First edition 2019-02 23500-1:2019 |
| 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 | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis… |
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: