Recognized standard
1135-4 Sixth edition 2015-12-01
FDA recognition 6-384 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-384 |
|---|---|
| Designation | 1135-4 Sixth edition 2015-12-01 |
| Title | Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications… |
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: