Recognized standard
15747 Third edition 2018-09
FDA recognition 6-501 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-501 |
|---|---|
| Designation | 15747 Third edition 2018-09 |
| Title | Plastic containers for intravenous injections |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml… |
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: