What is ISO 7886-3 about?
ISO 7886 discusses sterile hypodermic syringes for single use. ISO 7886-3 outlines the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling.
The syringes can be made of plastic, rubber, or other materials and can be with or without needle and needle protection features.
Note1: ISO 7886-3 does not specify the design of the auto-disable syringe feature
Note 2: ISO 7886-3 does not apply to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4), or syringes designed to be prefilled (covered by the ISO 11040 series). ISO 7886-3 does not address compatibility with injection fluids/vaccines.
Who is ISO 7886-3 for?
ISO 7886-3 on Sterile hypodermic syringes for single use are useful for:
- Manufacturers of sterile hypodermic syringes
- Test centres and medical laboratories for sterile hypodermic syringes
- Regulatory authorities
Why should you use ISO 7886-3?
Auto-disable syringe feature that passively activates upon delivering an injection of the nominal fixed dose to prevent subsequent reuse of the syringe and the needle.
ISO 7886-3 guideline provides general requirements, limits for acidity or alkalinity, Limits for extractable metals, lubricant, tolerance on graduated capacity, syringe design, performance, packaging, and information to be supplied by manufacturers. This ensures satisfactory operation and improves the quality of Auto-disabled syringes for fixed-dose immunization.
What’s changed since the last update?
BS EN ISO 7886-3:2020 supersedes ISO 7886-3:2005, which has been withdrawn. BS EN ISO 7886-3:2020 has an update of the references, mainly ISO 78861:2017 with respect to ISO 7886-3:2005
