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EN ISO 7886-3:2020

Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020) EN ISO 7886-3:2020

Publication date:   Oct 14, 2020

General information

60.60 Standard published   May 20, 2020

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

Buying

Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 7886-3:2009

NOW

PUBLISHED
EN ISO 7886-3:2020
60.60 Standard published
May 20, 2020