Recognized standard
8536-2 Third edition 2010-03-15
FDA recognition 6-242 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-242 |
|---|---|
| Designation | 8536-2 Third edition 2010-03-15 |
| Title | Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8536 2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in ISO 8536 2:2010 are intended 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: