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prEN ISO 7864

Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS 7864:2025) prEN ISO 7864

Publication date:   Nov 27, 2025

General information

40.60   Close of voting   Feb 17, 2026

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

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Scope

ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.
It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 7864:2016

NOW

IN_DEVELOPMENT
prEN ISO 7864
40.60 Close of voting
Feb 17, 2026




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