ISO 8536-13:2024
Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 6
- Дата публикации:
- 6 сентября 2024 г.
- Издание:
- ISO IS 8536 edition 2 version 1
- ICS:
- 11.040.20
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.
Abstract
Overview
ISO 8536-13:2024 - Infusion equipment for medical use - Part 13 specifies requirements for that are non‑sterile, single‑use subcomponents intended for inclusion in sterilized infusion sets. The standard covers devices with used to control intravenous infusion flow under conditions. It defines design, material assessment, physical and chemical requirements, and normative test methods to ensure safe, accurate and reliable flow regulation.
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