ISO 8536-1 Fourth edition 2011-09-01

Standard Organization:

ISO 8536-1 Fourth edition 2011-09-01
Infusion equipment for medical use - Part 1: Infusion glass bottles

• Recognition Date: 2013-08-06
• Recognition List: 031
• Recognition Number: 6-276
• 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 8536-1:2011 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

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