| ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)] |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 6-318 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Kathleen Fitzgerald FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6292 kathleen.fitzgerald@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 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5440 | Administration Set Docking Station | Class 2 | ODI |
| §880.5440 | Check Valve, Retrograde Flow (In-Line) | Class 2 | MJF |
| §880.5440 | Filter, Infusion Line | Class 2 | FPB |
| §880.5440 | Intravenous Extension Tubing Set | Class 2 | OJA |
| §880.5440 | Microfilter, Blood Transfusion | Class 2 | CAK |
| §880.5440 | Set, Administration, Intravascular | Class 2 | FPA |
| §880.5440 | Set, Blood Transfusion | Class 2 | BRZ |
| §880.5440 | Set, I.V. Fluid Transfer | Class 2 | LHI |
| §880.5440 | Stopcock, I.V. Set | Class 2 | FMG |
| §880.5440 | System/Device, Pharmacy Compounding | Class 2 | NEP |
| §880.5440 | Tubing, Fluid Delivery | Class 2 | FPK |
| Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)]. Document issued on July 11, 2008 |