Recognized standard
11608-3:2022
FDA recognition 6-477 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-477 |
|---|---|
| Designation | 11608-3:2022 |
| Title | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container… |
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: