Recognized standard
8536-5 Second edition 2004-02-01
FDA recognition 6-122 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-122 |
|---|---|
| Designation | 8536-5 Second edition 2004-02-01 |
| Title | Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 15, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. ISO 8536-5:2004 also provides… |
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: