| ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| Recognition Date | 2013-01-15 |
| Recognition List | 030 |
| Recognition Number | 6-122 |
| 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 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5440 | Set, Administration, Intravascular | Class 2 | FPA |
| Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008 |