Back

EVS-EN ISO 7886-3:2009

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

General information
Withdrawn from 02.06.2020
Base Documents
ISO 7886-3:2005; EN ISO 7886-3:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
02.06.2020
Main
03.12.2009
Main
Main
EVS-EN ISO 7886-3:2005
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.
*
*
*
PDF
13.42 € incl tax
Paper
13.42 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 7886-1:2018

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)
Newest version Valid from 16.04.2018
Main

EVS-EN ISO 7886-2:1999

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
Withdrawn from 02.06.2020
Main

EVS-EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
Newest version Valid from 04.10.2016
Main

EVS-EN ISO 80369-7:2017

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
Withdrawn from 01.06.2021