Need help?

EN ISO 7886-3:2009 Standard

wave
Save  

  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

  Related Standards

EN 60601-1:2006/AC:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

EN 80601-2-59:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening ther...

EN 80601-2-58:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal d...

EN 80601-2-35:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating device...

EN 62220-1-3:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 7886-3:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0