Abstract

Additional requirements for connectors for accessory access connection port

Status
Not Published
Public Enquiry End Date
30-Oct-2026
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
04-Sep-2026
Due Date
22-Jan-2027

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SIST EN ISO 5367:2023/oprA1:2026

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SIST EN ISO 5367:2023/oprA1:2026 is a draft amendment published by SIST for anaesthetic and respiratory equipment. It adds requirements for connectors used on accessory access connection ports in breathing sets and connectors, so manufacturers, testers and specifiers know how these ports are designed, marked and checked. It also clarifies how more than one adjacent accessory port can be handled and how flow-resistance conditions are stated.

What does SIST EN ISO 5367:2023/oprA1:2026 specify?

SIST EN ISO 5367:2023/oprA1:2026 specifies additional requirements for connectors for accessory access connection port on breathing sets. In practice, it tightens the connector design, marking and information needed for accessory ports used with functions such as gas measurement.

The amendment text is organized around new subclauses in Clause 6, plus an informative annex with rationale.

AnnexWhat it covers
Annex ARationale for the accessory connection port requirements and the note that clarifies how resistance values are expressed

What are the key requirements of SIST EN ISO 5367:2023/oprA1:2026?

Accessory connection ports

SIST EN ISO 5367:2023/oprA1:2026 requires accessory connection ports on breathing sets to use an L2 socket connector conforming with ISO 80369-7. That matters because the port format is part of the misconnection control strategy.

The port also needs a captive means of sealing, such as a tethered cap or plug. This keeps the sealing element with the device and reduces the chance of losing it during use.

The port must be marked with either the ISO 7000-1641 symbol or, if marking is the primary risk control measure, the ISO 7010-M002 safety sign. The instructions for use must include a warning about the risk of inadvertent connection with another Luer connector and the need for special measures to reduce foreseeable harm.

More than one accessory connection port

SIST EN ISO 5367:2023/oprA1:2026 allows an alternative connector design when two or more adjacent accessory connection ports have different intended applications. In that case, the design is evaluated as an alternative small-bore connector in accordance with ISO 80369-1.

The document links this choice to risk management. The note points to examples such as a permanently attached line, colour coded ports and marking, which shows the type of practical controls a manufacturer may use to reduce the chance of a wrong connection.

Flow resistance and conformity checking

SIST EN ISO 5367:2023/oprA1:2026 adds notes to the resistance-to-flow tables in Clause 6.5. The notes state that airflow is to be expressed as STPD, which gives a common reference condition for reporting resistance values.

Conformity for the accessory connection ports is checked by inspection and, where applicable, by applying the tests of ISO 80369-7:2021. For a buyer or quality team, that means the design is not only specified on paper - it is also meant to be verified against the connector standard and the required markings.

What terms does SIST EN ISO 5367:2023/oprA1:2026 define?

  • Accessory connection port - a port on a breathing set used to connect accessories, for example for gas measurement.
  • L2 socket connector - the connector type required for accessory connection ports under ISO 80369-7.
  • Captive means of sealing - a sealing cap or plug that stays attached to the port, such as a tethered cap.
  • Alternative small-bore connector - a different connector design used for adjacent ports with different intended applications and assessed under ISO 80369-1.
  • Standard Temperature and Pressure Dry (STPD) - the reference condition used in the added notes for expressing airflow.
  • Risk management file - the record used to judge whether the risk of inadvertent connection is unacceptable and which controls are chosen.

Who uses SIST EN ISO 5367:2023/oprA1:2026?

SIST EN ISO 5367:2023/oprA1:2026 is used by manufacturers of anaesthetic and respiratory equipment, especially those designing breathing sets and accessory ports. It is also used by test laboratories, conformity assessment teams, quality managers and regulatory staff who need to verify connector type, marking, instructions for use and flow-resistance reporting.

It is relevant where accessory ports are used for gas measurement, pressure monitoring or gas sampling. Buyers and specifiers can use it to check that a breathing set uses the connector and labelling approach they need.

What changed in SIST EN ISO 5367:2023/oprA1:2026 from the previous edition?

SIST EN ISO 5367:2023/oprA1:2026 amends ISO 5367:2023. The amendment adds:

  • a new subclause for accessory connection ports
  • a new subclause for using more than one adjacent accessory connection port with different intended applications
  • notes to the flow-resistance clause so airflow is expressed as STPD
  • Annex A rationale for the connector choice and the resistance-value clarification

Which standards are used with SIST EN ISO 5367:2023/oprA1:2026?

  • ISO 80369-7:2021 - used for the L2 socket connector requirement and the related conformity check.
  • ISO 80369-1 - used when an alternative small-bore connector design is selected for adjacent ports.
  • IEC 60601-1:2005+AMD1:2012+AMD2:2020 - cited for the symbol and safety-sign references used in marking.
  • ISO 7000-1641 - the symbol option for marking accessory connection ports.
  • ISO 7010-M002 - the safety-sign option when marking is the primary risk control measure.
  • ISO 4135:2022 - used in Annex A for the definition of dry in STPD.
  • ISO 14971 - referenced in the rationale for risk management of misconnection hazards.

What does the SIST EN ISO 5367:2023/oprA1:2026 document contain?

SIST EN ISO 5367:2023/oprA1:2026 contains amendment text for Clause 6, including the new accessory-port requirements and the rule for multiple adjacent ports. It also contains notes added to the resistance-to-flow tables so the reporting condition is clear.

Annex A gives the rationale behind the connector decision and the STPD clarification. The document therefore serves both as a design/specification amendment and as a record of why the added requirements were chosen.

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Effective Date
26-Nov-2025

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SIST EN ISO 5367:2023/oprA1:2026

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Frequently Asked Questions

SIST EN ISO 5367:2023/oprA1:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1: Additional requirements for connectors for accessory access connection port (ISO 5367:2023/DAmd1:2026)". This standard covers: Additional requirements for connectors for accessory access connection port

Additional requirements for connectors for accessory access connection port

SIST EN ISO 5367:2023/oprA1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN ISO 5367:2023/oprA1:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 5367:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN ISO 5367:2023/oprA1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-oktober-2026
Anestezijska in dihalna oprema - Dihalni seti in priključki - Dopolnilo A1: Dodatne
zahteve za priključke za priključni priključek za dodatno opremo (ISO
5367:2023/DAmd1:2026)
Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1:
Additional requirements for connectors for accessory access connection port (ISO
5367:2023/DAmd1:2026)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke - Änderung 1
(ISO 5367:2023/DAmd 1:2026)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords - Amendement 1: Exigences supplémentaires relatives aux raccords destinés
aux orifices de raccordement pour accessoires (ISO 5367:2023/DAmd1:2026)
Ta slovenski standard je istoveten z: EN ISO 5367:2023/prA1:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
Amendment
ISO 5367:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Breathing sets and
connectors
Voting begins on:
2026-08-19
AMENDMENT 1: Additional
Voting terminates on:
requirements for connectors for 2026-11-11
accessory access connection port
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
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Reference number
ISO 5367:2023/DAM 1:2026(en)
DRAFT
ISO 5367:2023/DAM 1:2026(en)
Amendment
ISO 5367:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Breathing sets and
connectors
Voting begins on:
AMENDMENT 1: Additional
Voting terminates on:
requirements for connectors for
accessory access connection port
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland Reference number
ISO 5367:2023/DAM 1:2026(en)
ii
ISO 5367:2023/DAM 1:2026(en)
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