EN ISO 8536-13:2024 PDF

Name: EN ISO 8536-13:2024 — Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)
SKU: EN ISO 8536-13:2024
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Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)

Название (английский):

EN ISO 8536-13:2024

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 25 сентября 2024 г.
Издание:: CEN EN 8536 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

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

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 8536-13:2024 - "Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact" specifies safety, performance and test requirements for non‑sterile, single‑use graduated flow regulators (GFRs) used as subcomponents in sterilized infusion sets. The standard applies to GFRs that control intravenous infusion flow under gravity feed conditions and was prepared jointly by ISO TC 76 and CEN TC 205. EN ISO 8536-13:2024 supersedes the earlier edition and aligns physical, chemical and design expectations for manufacturers and test laboratories.

Key topics and technical requirements

Scope & definition

GFR = subcomponent with graduation and fluid contact for setting liquid flow.
Covers GFRs intended for single use in infusion sets (gravity feed).

Design and markings

Must be designed for constant flow regulation and to avoid accidental flow change.
Scale must clearly indicate open and closed positions and manufacturer‑defined scale positions.

Flow performance

Stability requirement: when tested, flow stability shall be at least within ±10% during the test time.
GFRs must deliver flow rates according to the manufacturer’s scale and tolerances (test methods in Annex A).

Physical requirements and tests

Particulate contamination: inner surface smooth/clean; testing per ISO 8536-4 with limits on particle counts.
Tensile strength: withstand a static longitudinal tensile force of ≥15 N for 15 s after pre‑conditioning.
Leakage: must be leak‑tight in open, closed and intermediate positions; no leakage under specified air/water test conditions.
Preconditioning: tests consider sterilization, transport, ageing and number of activations.

Materials and biocompatibility

Materials must meet chemical requirements and be evaluated per ISO 10993-1.

Normative references

Key referenced documents include ISO 8536-4, ISO 10993-1, and ISO 80000-4.

Applications and who uses it

Medical device manufacturers designing and producing infusion sets and GFR subcomponents.

Quality assurance and regulatory affairs teams ensuring product compliance with EU/CEN and international requirements.

Test laboratories performing physical, particulate, tensile and leakage tests according to Annex A.

Purchasing and procurement professionals specifying compliant infusion components.

Healthcare facilities and clinical engineers evaluating device safety and compatibility for gravity‑fed IV therapy.

Related standards

ISO 8536-4 - Infusion sets for single use, gravity feed (test methods referenced)

ISO 10993-1 - Biological evaluation of medical devices (biocompatibility)

ISO 80000-4 - Quantities and units - mechanics

EN ISO 8536-13:2024 is essential for ensuring safe, reliable graduated flow regulators in infusion equipment, supporting regulatory compliance, consistent flow control, and reduced particulate and leakage risks in single‑use infusion systems.

EN ISO 8536-13:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

ISO 8536-13:2024

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

SIST EN ISO 8536-4:2020

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 80000-4:2019/A1:2025

Quantities and units - Part 4: Mechanics - Amendment 1 (ISO 80000-4:2019/Amd 1:2025)