This document specifies the properties and performance of sterile single-use hypodermic
syringes with or without needle, made of plastic, rubber or other materials and intended for the
filling and the injection of vaccines immediately after filling. Upon delivering a fixed dose of
vaccine, the syringe is automatically rendered unusable.
This document does not specify the design of the auto-disable feature, which is left to the
discretion of the manufacturer.
This document is not applicable to syringes for use with insulin (specified in ISO 8537), syringes
for use with power-driven syringe pumps (specified in ISO 7886-2), reuse prevention syringes
(specified in ISO 7886-4) and syringes designed to be prefilled. It does not address compatibility
with injection fluids/vaccines.
NOTE – Prefilled syringes are covered in the ISO 11040- series.
