ISO 7886-3:2020 PDF

Scope: This document specifies 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 feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable 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 compatibility with injection fluids/vaccines.

ISO 7886-3:2020 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*， 2021-04-30 Update
ISO 8537:2016 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

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