EN ISO 8536-16:2025

Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025)

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

Infusionsgeräte zur medizinischen Verwendung - Teil 16: Infusionsgeräte mit volumetrischen Infusionsreglern zur einmaligen Verwendung (ISO 8536-16:2025)

Dieses Dokument legt Anforderungen an für den einmaligen Gebrauch bestimmte sterile Infusionssets für Schwerkraftinfusionen fest, die gemeinsam mit volumetrischen Infusionsreglern nach IEC 60601 2 24 [1] verwendet werden.

Matériel de perfusion à usage médical - Partie 16: Appareils de perfusion à usage unique avec régulateurs de perfusion volumétriques (ISO 8536-16:2025)

Le présent document spécifie les exigences relatives aux appareils de perfusion à alimentation par gravité, à usage unique, stérilisés, utilisés conjointement avec les régulateurs de perfusion volumétriques de l'IEC 60601-2-24.

Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski kompleti za enkratno uporabo z volumetričnimi infuzijskimi krmilniki (ISO 8536-16:2025)

Ta dokument določa zahteve za sterilizirane infuzijske komplete za enkratno uporabo, delujoče na osnovi gravitacije, ki se uporabljajo skupaj z volumetričnimi infuzijskimi krmilniki iz standarda IEC 60601-2-24.

General Information

• Status: Published
• Publication Date: 12-Aug-2025
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 13-Aug-2025
• Due Date: 21-Nov-2026
• Completion Date: 13-Aug-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 8536-16:2025 - Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025)

Overview

EN ISO 8536-16:2025 (ISO 8536-16:2025) specifies requirements for sterilized, single-use, gravity-feed infusion sets designed to be used with volumetric infusion controllers (see IEC 60601-2-24). The standard covers design elements, materials, performance and safety tests, labelling, packaging and disposal considerations for infusion sets intended for medical use. It addresses sets used with both rigid and collapsible containers and defines key components such as flow elements, drip chambers, tubing and air-inlet devices.

Key topics and technical requirements

The standard defines technical requirements across several domains:

• General design and components

  • Required parts (e.g., closure-piercing device, air-inlet with filter, drip chamber, fluid filter, tubing, flow regulator, flow element, injection site, male conical fitting).
  • Configurations for rigid vs. collapsible fluid containers.

• Materials and chemical/biological safety

  • Material selection and compatibility for sterilized, single-use devices.
  • Chemical and biological requirements to protect patient safety (biocompatibility and sterility).

• Physical performance tests

  • Tests and acceptance criteria for particulate contamination, leakage, tensile resistance, flow rate and flow regulator performance.
  • Requirements for closure-piercing devices, air-inlet devices, tubing integrity, fluid filters and drip-chamber behaviour.
  • Annex A contains normative physical test methods.

• Labelling, packaging and disposal

  • Unit and multi-unit container labelling requirements, use of standardized symbols (ISO 15223‑1, ISO 7000).
  • Packaging to maintain sterility and instructions for safe disposal of single-use infusion sets.

• Terminology and scope

  • Definitions (e.g., volumetric infusion controller, flow element, lifetime) to ensure consistent interpretation.

Applications and who uses this standard

EN ISO 8536-16:2025 is intended for:

• Manufacturers of infusion sets and accessories designing single-use, gravity-feed sets compatible with volumetric infusion controllers.
• Medical device engineers and product development teams ensuring device interoperability and regulatory compliance.
• Quality assurance, regulatory and conformity assessment bodies assessing performance, safety and labelling.
• Clinical procurement and biomedical departments evaluating devices for hospital use.
• Testing laboratories performing the normative physical and biological tests.

Adoption supports safe, compatible infusion therapy solutions, reduces risk of device failure, and helps manufacturers meet European and international regulatory expectations.

Related standards

• IEC 60601-2-24 (volumetric infusion controllers)
• ISO 8536-4 (infusion sets - gravity feed)
• ISO 15223-1, ISO 7000 (symbols and labelling)
• ISO 3696 (water quality for tests), ISO 14644-1 (cleanroom classification)

Keywords: EN ISO 8536-16:2025, ISO 8536-16, infusion sets, volumetric infusion controllers, gravity feed, single-use, sterilized infusion equipment, medical device standard.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2025
Infuzijska oprema za uporabo v medicini - 15. del: Infuzijski kompleti za enkratno
uporabo z volumetričnimi infuzijskimi krmilniki (ISO 8536-16:2025)
Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric
infusion controllers (ISO 8536-16:2025)
Infusionsgeräte zur medizinischen Verwendung - Teil 16: Infusionsgeräte mit
volumetrischen Infusionsreglern zur einmaligen Verwendung (ISO 8536-16:2025)
Matériel de perfusion à usage médical - Partie 16: Appareils de perfusion à usage
unique avec régulateurs de perfusion volumétriques (ISO 8536-16:2025)
Ta slovenski standard je istoveten z: EN ISO 8536-16:2025
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8536-16
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Infusion equipment for medical use - Part 16: Infusion sets
for single use with volumetric infusion controllers (ISO
8536-16:2025)
Matériel de perfusion à usage médical - Partie 16: Infusionsgeräte zur medizinischen Verwendung - Teil
Appareils de perfusion à usage unique avec régulateurs 16: Infusionsgeräte mit volumetrischen
de perfusion volumétriques (ISO 8536-16:2025) Infusionsreglern zur einmaligen Verwendung (ISO
8536-16:2025)
This European Standard was approved by CEN on 12 August 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-16:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8536-16:2025) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 8536-16:2025 has been approved by CEN as EN ISO 8536-16:2025 without any
modification.
International
Standard
ISO 8536-16
First edition
Infusion equipment for medical use —
2025-08
Part 16:
Infusion sets for single use with
volumetric infusion controllers
Matériel de perfusion à usage médical —
Partie 16: Appareils de perfusion à usage unique avec régulateurs
de perfusion volumétriques
Reference number
ISO 8536-16:2025(en) © ISO 2025

ISO 8536-16:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 8536-16:2025(en)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 6
6 Physical requirements . 6
6.1 General .6
6.2 Particulate contamination .6
6.3 Leakage .6
6.4 Tensile resistance . .6
6.5 Flow rate of infusion set .6
6.6 Flow regulator .6
6.7 Closure-piercing device .6
6.8 Air-inlet device .7
6.9 Tubing .7
6.10 Fluid filter .7
6.11 Drip chamber and drip tube .7
6.12 Injection site .7
6.13 Male conical fitting .7
6.14 Protective caps .7
7 Chemical requirements . 7
8 Biological requirements . 7
9 Labelling . 7
9.1 General .7
9.2 Unit container .7
9.3 Shelf or multi-unit container .8
10 Packaging. 8
11 Disposal . 8
Annex A (normative) Physical tests . . 9
Bibliography .12

iii
ISO 8536-16:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 8536 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
International Standard ISO 8536-16:2025(en)
Infusion equipment for medical use —
Part 16:
Infusion sets for single use with volumetric infusion
controllers
1 Scope
Th
...