ISO 7886-3:2005 PDF

Scope: This part of ISO 7886 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. This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer. This part of ISO 7886 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. NOTE A fourth part of ISO 7886 is being prepared to cover syringes with reuse prevention feature.

ISO 7886-3:2005 Referenced Document

ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
ISO 7864:1993 Sterile hypodermic needles for single use
ISO 7886-1:1993 Sterile hypodermic syringes for single use; part 1: syringes for manual use
ISO 8537:1991 Sterile single-use syringes, with or without needle, for insulin
ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods*， 2016-08-01 Update

2020 ISO 7886-3:2020 Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization
2005 ISO 7886-3:2005 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization