Recognized standard
8536-1 Fourth edition 2011-09-01
FDA recognition 6-276 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-276 |
|---|---|
| Designation | 8536-1 Fourth edition 2011-09-01 |
| Title | Infusion equipment for medical use - Part 1: Infusion glass bottles |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. |
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: