Recognized standard
8536-2 Fourth edition 2023-01
FDA recognition 6-506 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-506 |
|---|---|
| Designation | 8536-2 Fourth edition 2023-01 |
| 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 | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document 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 this document 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: