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EN ISO 7886-3:2009 Standard

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  Keywords:

#vaccines #part #specified #injection #syringe

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This part of ISO 7886 specifies the properties and performance of sterile single-use hypodermic syringes withor without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines orfor the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine, the syringe isautomatically rendered unusable.This part of ISO 7886 does not specify the design of the auto-disable feature, which is left to the discretion ofthe manufacturer.This part of ISO 7886 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes madeof 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 addresscompatibility with injection fluids/vaccines.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 7886-3:2005"

Anyway is still possible use the "EN ISO 7886-3:2005" until March 21st, 2010

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