Recognized standard
20698 First Edition 2018-07
FDA recognition 6-495 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-495 |
|---|---|
| Designation | 20698 First Edition 2018-07 |
| Title | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2023 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | ISO 20698 specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications. This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied… |
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: