| ISO 8536-7 Third edition 2009-01-15 Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-216 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 8536-7:2009 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5440 | Set, I.V. Fluid Transfer | Class 2 | LHI |
| Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008 |