Recognized standard
11608-1:2022
FDA recognition 6-478 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-478 |
|---|---|
| Designation | 11608-1:2022 |
| Title | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems |
| 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 Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular… |
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: