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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Withdrawn from 02.06.2020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Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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:

Standard history

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.

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