ISO/AWI 8536-13

Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact

General information

Current stage: 20.00 New project registered in TC/SC work programme Oct 13, 2025

Originator: ISO

Owner: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Type: International Standard

Scope

This document specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 8536-13:2024

NOW

IN_DEVELOPMENT
ISO/AWI 8536-13
20.00 New project registered in TC/SC work programme
Oct 13, 2025