| ISO 8536-10 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 6-360 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 8.3 Label on shelf or multi-unit container. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@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 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2015 includes the following:
a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
b) units with injection site or check valve;
c) stoppers or adapters.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5440 | Set, Administration, Intravascular | Class 2 | FPA |
| Intravascular Administration Sets Premarket Notification Submissions [510(k)] - Guidance for Industry and FDA , Issued July 2008. |