prEN ISO 8536-9 rev

Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment

General information

10.99   New project approved   Oct 14, 2025

CEN

CEN/TC 205 Non-active medical devices

European Norm

Scope

ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by ISO 8536-9:2015:
a) syringe pump lines (SPL);
b) connecting lines (CL);
c) lines with integrated injection cannula (LIC).

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 8536-9:2015

NOW

IN_DEVELOPMENT
prEN ISO 8536-9 rev
10.99 New project approved
Oct 14, 2025