prEN ISO 80369-2
(Main)Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications
This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in breathing systems applications and driving gases applications of medical devices and accessories that contain or directly or indirectly convey liquids or gases to or from a patient or to provide driving power to medical devices or accessories.
This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems or accessories, even if currently not required by the relevant particular device standards. It is expected that when the relevant particular device standards are revised, requirements for small-bore connectors, as specified in this part of ISO 80369, will be included.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 2: Verbindungsstücke für respiratorische Anwendungen
Joints de petite dimension pour liquides et gaz pour des applications en santé - Partie 2 : Joints pour systèmes respiratoires et applications au gaz propulseur
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del: Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2021
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del:
Priključki za respiratorno uporabo (ISO/DIS 80369-2:2021)
Small-bore connectors for liquids and gases in healthcare applications - Part 2:
Connectors for respiratory applications (ISO/DIS 80369-2:2021)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und
Antriebsgasanwendungen (ISO/DIS 80369-2:2021)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
2: Raccords destinés à des applications respiratoires (ISO/DIS 80369-2:2021)
Ta slovenski standard je istoveten z: prEN ISO 80369-2
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 INTERNATIONAL STANDARD
ISO/DIS 80369-2
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-05-03 2021-07-26
Small-bore connectors for liquids and gases in healthcare
applications —
Part 2:
Connectors for respiratory applications
ICS: 11.040.20; 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80369-2:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
ISO/DIS 80369-2:2021(E)
© ISO 2021
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 2021 – All rights reserved
ISO/DIS 80369-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General requirements for the respiratory application . 3
4.2 Material used for small-bore connectors . 3
4.3 Type tests . 3
5 Dimensional requirements . 3
5.1 R1 small-bore connectors . 3
5.2 R2 small-bore connectors . 4
6 Performance requirements . 4
6.1 * Leakage by pressure decay . 4
6.2 Subatmospheric pressure air leakage . 4
6.3 Stress cracking . 4
6.4 Resistance to separation from axial load. 5
6.5 Resistance to separation from unscrewing . 5
6.6 Resistance to overriding . 5
6.7 Disconnection by unscrewing . 5
Annex A (informative) Rationale and guidance . 6
Annex B (normative) Small-bore connectors for breathing systems and driving gases .7
Annex C (normative) Reference connectors for testing small-bore connectors for breathing
systems and driving gases .16
Annex D (informative) Assessment of medical devices and their attributeswith connections
within this application .30
Annex E (informative) Summary of the usability requirements for small-bore connectors for
breathing systems and gases for respiratory use .35
Annex F (informative) Summary of small-bore connector design requirementsfor breathing
systems and gases for respiratory use applications .37
Annex G (informative) Summary of assessment of the design of the small-bore
connectorsfor breathing systems and gases for respiratory use .42
Annex H (informative) Reference to the Essential Principles .45
Annex I (informative) Terminology — Alphabetized index of defined terms .46
Bibliography .47
ISO/DIS 80369-2:2021(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 intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www .iso .org/ directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www .iso .org/ patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO 80369-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices and IEC/TC 62, Electrical equipment, Subcommittee SC 62D, Electrical
equipment in medical practice, in collaboration with the European Committee for Standardization
(CEN) Technical Committee, CEN/CENELEC JTC3/WG 2, Small-bore connectors, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This is the first edition of ISO 80369-2.
iv © ISO 2021 – All rights reserved
ISO/DIS 80369-2:2021(E)
Introduction
This International Standard was developed because of several incidents, with catastrophic
consequences, resultant from inappropriate medication, liquid nutritional formula or gas being
administered via the incorrect route. Many incidents have been reported leading to international
recognition of the importance of these issues, and a need has been identified to develop specific
connectors for medical devices and their accessories used to deliver fluids in other applications.
The ISO 80369 series was developed to prevent misconnection between small-bore connectors used in
different applications. Part 1 specifies the requirements necessary to verify the designs and dimensions
of small-bore connectors to ensure that:
a) they do not misconnect with other small-bore connectors; and
b) they safely and securely connect with their mating half.
Part 20 contains the common test methods to support the performance requirements for small-bore
connectors.
This part of ISO 80369 specifies the design, the dimensions and the drawings as well as performance
of small-bore connectors intended for use as an ancillary port connection in a breathing system and
respirable driving gases applications. The informative Annex D through Annex G describe the methods
by which these designs have been assessed. Other parts of ISO 80369 include requirements for small-
bore connectors used in different application categories.
Connectors manufactured to the dimensions set out within this International Standard are dimensionally
incompatible with any of the other connectors for applications identified in the ISO 80369 series of
documents for small-bore connectors, except as indicated in Annex G. If fitted to the relevant medical
devices and accessories, these connectors should reduce the risk of gas, medication and liquid nutritional
formula being delivered via an alternative route.
By conforming with the requirements of this document manufacturers of medical devices incorporating
these respiratory small-bore connectors can presume conformance with the requirements of
ISO 80369-1.
In this document, the following print types are used:
— Requirements and definitions: roman type.
— Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
— Terms defined in Clause 3 of this document or as noted: italics.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” is used to describe a permission (e.g. a permissible way to achieve conformance with a
requirement or test)
...
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