| ISO 8536-6 Second edition 2009-11-15 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-239 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Alan Stevens FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6294 alan.stevens@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 8536-6:2009 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8536-6:2009 are intended for single use only.
| 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. |