ISO 7886-3 Sterile hypodermic syringes for single use test machine

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ISO 7886-3 Sterile hypodermic syringes for single use test machine

ISO 7886-3:2020

Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization

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 ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
  • 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 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
  • 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 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
  • ASTM D999-01, Standard methods for vibration testing of shipping containers
  • ASTM D5276-98, Standard test method for drop test of loaded containers by free fall

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