| ISO 7886-3 First edition 2005-03-01 Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization |
| Recognition Date | 2013-01-15 |
| Recognition List | 030 |
| Recognition Number | 6-148 |
| 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 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.
ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer
ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5860 | Syringe, Antistick | Class 2 | MEG |
| §880.5860 | Syringe, Piston | Class 2 | FMF |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| There is no relevant guidance developed at this time. |