SIST EN ISO 80369-3:2016/A1:2023
(Amendment)Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-3:2016/Amd 1:2019)
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del: Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
General Information
Relations
Overview
SIST EN ISO 80369-3:2016/A1:2023 is an essential European amendment to the international standard ISO 80369-3:2016, focused on small-bore connectors for liquids and gases in healthcare applications. Specifically, Part 3 addresses connectors designed for enteral applications, which are medical devices used for delivering nutrition or medication directly into the gastrointestinal tract. This amendment introduces updates to dimension specifications and testing protocols to enhance safety and interoperability within healthcare settings.
Developed by ISO Technical Committee ISO/TC 210 and adopted by CEN-CENELEC JTC 3, this standard reflects the latest best practices for minimizing fluid misconnections and improving compatibility for enteral connectors. It was approved in November 2022 and is expected to be incorporated as a national standard by May 2023 in all CEN member countries.
Key Topics
- Small-bore connector design: Focuses on precise dimensions for male E1 connectors used in enteral feeding systems, including new parameters a3 and r3 for internal lumen geometry to ensure improved fluid flow and device compatibility.
- Dimensional updates: Adjusts critical connector measurements such as the male taper angle, tip diameter, thread dimensions, and bore tolerances to optimize connector performance and safety.
- Testing requirements: Specifies reference connectors and test methods for leak testing, disconnection resistance, stress cracking, and prevention of non-interconnectable usage with non-enteral devices.
- Safety enhancements: Removes exceptions related to rectal medical devices to ensure all enteral connectors comply with the tightened requirements, reducing risks of misconnections in healthcare.
- Standard compliance: Mandates CEN-CENELEC members implement the amendment identically or by endorsement, ensuring uniform adoption across European healthcare systems.
Applications
The amendment is highly relevant for manufacturers, healthcare providers, and regulatory bodies involved with enteral nutrition and medication delivery:
- Medical device manufacturers: Design and produce enteral connectors with standardized dimensions ensuring interoperability and patient safety.
- Healthcare facilities: Use standardized connectors to prevent dangerous misconnections between enteral and non-enteral systems, improving patient care outcomes.
- Regulatory authorities: Assess conformity of enteral medical devices with updated dimensional and performance standards during approval processes.
- Quality management teams: Implement controls and audits aligned with ISO 80369-3:2016/A1:2022 to meet compliance and improve device quality assurance.
This amendment facilitates safer enteral feeding protocols, contributing to overall patient safety by reducing accidental cross-connection errors involving small-bore connectors.
Related Standards
- ISO 80369 series: A set of international standards covering small-bore connectors for various medical applications, including infusion (Part 2), intravascular (Part 6), and respiratory (Part 5) devices, all designed to reduce misconnection risks.
- EN ISO 80369-1:2010: Provides general requirements and test methods for small-bore connectors in healthcare, referenced in this amendment for verifying non-interconnectable characteristics.
- ISO/TC 210 standards: Focus on quality management and safety of medical devices, providing overarching guidelines applicable to the development and implementation of standards such as ISO 80369-3.
- Medical device directives and regulations: European MDR and FDA regulations reference compliance with ISO connector standards as part of safety and performance requirements.
By adhering to SIST EN ISO 80369-3:2016/A1:2023, medical device manufacturers and healthcare providers ensure enhanced safety, interoperability, and regulatory compliance for enteral liquid and gas delivery systems, supporting high-quality patient care globally.
Keywords: EN ISO 80369-3:2016/A1, small-bore connectors, enteral applications, healthcare connectors, medical device standards, misconnection prevention, enteral feeding connectors, ISO 80369 amendment, CEN standards, medical device interoperability.
Frequently Asked Questions
SIST EN ISO 80369-3:2016/A1:2023 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)". This standard covers: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
SIST EN ISO 80369-3:2016/A1:2023 is classified under the following ICS (International Classification for Standards) categories: 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 80369-3:2016/A1:2023 has the following relationships with other standards: It is inter standard links to SIST EN ISO 80369-3:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 80369-3:2016/A1:2023 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 80369-3:2016/A1:2023 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2023
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 3. del:
Priključki za enteralno uporabo - Dopolnilo A1 (ISO 80369-3:2016/Amd 1:2019)
Small-bore connectors for liquids and gases in healthcare applications - Part 3:
Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 3: Verbindungsstücke für enterale Anwendungen -
Änderung 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
3: Raccords destinés à des applications entérales - Amendement 1 (ISO 80369-
3:2016/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 80369-3:2016/A1:2022
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN ISO 80369-3:2016/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2022
ICS 11.040.25
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 3: Connectors for enteral applications -
Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 3: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications entérales - Amendement 1 Anwendungen - Teil 3: Verbindungsstücke für enterale
(ISO 80369-3:2016/Amd 1:2019) Anwendungen - Änderung 1 (ISO 80369-3:2016/Amd
1:2019)
This amendment A1 modifies the European Standard EN ISO 80369-3:2016; it was approved by CEN on 21 November 2022.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant 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 and CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees 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.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-3:2016/A1:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 80369-3:2016/Amd 1:2019 has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for medical devices” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 80369-3:2016/A1:2022 by
Technical Committee CEN-CENELEC/ JTC 3 “Quality management and corresponding general aspects
for medical devices” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 80369-3:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2023, and
conflicting national standards shall be withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC 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.
A complete listing of these bodies can be found on the CEN and CENELEC websites.
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 80369-3:2016/Amd 1:2019 has been approved by CEN-CENELEC as EN ISO 80369-
3:2016/A1:2022 without any modification.
INTERNATIONAL ISO
STANDARD 80369-3
First edition
2016-07-01
AMENDMENT 1
2019-02
Small-bore connectors for liquids and
gases in healthcare applications —
Part 3:
Connectors for enteral applications
AMENDMENT 1
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 3: Raccords destinés à des applications entérales
AMENDEMENT 1
Reference number
ISO 80369-3:2016/Amd.1:2019(E)
©
ISO 2019
ISO 80369-3:2016/Amd.1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2019 – All rights reserved
ISO 80369-3:2016/Amd.1:2019(E)
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, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those i
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