Recognized standard
23500-2 First edition 2019-02 23500-2:2019
FDA recognition 9-134 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-134 |
|---|---|
| Designation | 23500-2 First edition 2019-02 23500-2:2019 |
| Title | Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications 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) | 1.1 General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies. 1.2 Inclusions This document covers devices used to treat potable water intended for use in 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: