ISO 8536-6 Second edition 2009-11-15

Standard Organization:

ISO 8536-6 Second edition 2009-11-15
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles

Recognition Date2013-08-06
Recognition List031
Recognition Number6-239
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

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI

FDA Guidance:

Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008.


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