SSH EN ISO 7886-3:2009

Shiringat sterile për përdorim të vetëm mjekësor - Pjesa 3: Shiringat auto-disable për imunizim të dozës fikse (ISO 7886-3:2005)

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Scope

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.

Related directives

Directives related to this standards.