EN ISO 80369-2:2024
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 2: Verbindungsstücke für respiratorische Anwendungen (ISO 80369-2:2024)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 2: Raccords destinés à des applications respiratoires (ISO 80369-2:2024)
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del: Priključki za respiratorno uporabo (ISO 80369-2:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 2. del:
Priključki za respiratorno uporabo (ISO 80369-2:2024)
Small-bore connectors for liquids and gases in healthcare applications - Part 2:
Connectors for respiratory applications (ISO 80369-2:2024)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 2: Verbindungsstücke für Atemsysteme und
Antriebsgasanwendungen (ISO 80369-2:2024)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
2: Raccords destinés à des applications respiratoires (ISO 80369-2:2024)
Ta slovenski standard je istoveten z: EN ISO 80369-2:2024
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
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.
EUROPEAN STANDARD EN ISO 80369-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2024
ICS 11.040.20; 11.040.10
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 2: Connectors for respiratory
applications (ISO 80369-2:2024)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 2: Raccords Flüssigkeiten und Gase in medizinischen
destinés à des applications respiratoires (ISO 80369- Anwendungen - Teil 2: Verbindungsstücke für
2:2024) respiratorische Anwendungen (ISO 80369-2:2024)
This European Standard was approved by CEN on 3 July 2024.
CEN and CENELEC 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 and CENELEC 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 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
© 2024 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-2:2024 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
General Safety and Performance Requirements of Regulation (EU) 2017/745
aimed to be covered . 4
European foreword
This document (EN ISO 80369-2:2024) has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for products with a health purpose
including medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3
“Quality management and corresponding general aspects for medical devices” the secretariat of
which is held by NEN.
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 2025, and conflicting national
standards shall be withdrawn at the latest by February 2025.
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.
This document has been prepared under a standardization request addressed to CEN and
CENELEC by the European Commission. The Standing Committee of the EFTA States
subsequently approves these requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of
this document.
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
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 80369-2:2024 has been approved by CEN-CENELEC as EN ISO 80369-2:2024
without any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed
to be covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745
of 5 April 2017 concerning medical devices [OJ L 117] and to system or process requirements
including those relating to quality management systems, risk management, post-market
surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the
limits of the scope of this standard, a presumption of conformity with the corresponding
General Safety and Performance Requirements of that Regulation, and associated EFTA
Regulations.
Where a definition in this standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in this Annex Z. For the purpose of
using this standard in support of the requirements set out in Regulation (EU) 2017/745, the
definitions set out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this
standard can differ from the scope of the European Regulation that it supports. As the scope of
the applicable regulatory requirements differ from nation to nation and region to region, the
standard can only support European regulatory requirements to the extent of the scope of
the European regulation for medical devices (EU) 2017/745.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks
have to be ‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible
and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’,
’removed or minimized as far as possible’, or ‘minimized’, according to the wording of the corresponding
General Safety and Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General
Safety and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the
Regulation.
, it means
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1
that it is not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation
(EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and Perfor- Clause(s) /
mance Requirements of subclause(s) of this EN
Remarks / Notes
Regu- lation (EU)
2017/745
14.1 4, 5, 6, 7 This requirement is partially covered in
that intended connections do not leak
and can only be connected to intended
medical devices or accessories.
Misconnections between small-bore
connectors of this series of standards,
which could result in an unacceptable
risk, are made impossible by design.
14.5 4, 5, 6, 7 This requirement is partially covered in
that by ensuring that the intended
connections do not leak and can only be
connected to intended medical devices or
accessories.
20.4 4, 5, 6, 7 This requirement is partially covered in
that intended connections do not leak
and can only be connected to intended
medical devices or accessories.
Misconnections between small-bore
connectors of this series of standards,
which could result in an unacceptable
risk, are made impossible by design.
20.5 4, 5, 6, 7 This requirement is partially covered in
that intended connections can only be
connected to intended medical devices or
accessories. Misconnections between
small-bore connectors of this series of
standards, which could result in an
unacceptable risk, are made impossible
by design.
21.1 4, 5, 6, 7 This requirement is partially covered in
that by ensuring that the intended
connections do not leak and can only be
connected to intended medical devices or
accessories. Such connections permit a
medical device to be capable of
controlling the flowrate.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users
of this standard should consult frequently the latest list published in the Official Journal of the
European Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope
of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive
2006/42/EC on Machinery, in accordance with Article 1(12) of Regulation (EU) 2017/745, the
following Table ZA.2 details the relevant Essential Health and Safety Requirements of Directive
2006/42/EC on Machinery to the extent to which they are more specific than the General Safety
and Performance Requirements set out in Chapter II of Annex I of Regulation (EU) 2017/745
along with the corresponding clauses of this European Standard. Table ZA.2, however, does not
imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Where a definition in this standard differs from a definition of the same term set out in
Regulation (EU) 2017/745, the differences shall be indicated in the Annex Z. For the purpose of
using this standard in support of the requirements set out in Regulation (EU) 2017/745, the
definitions set out in this Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this
standard can differ from the scope of the European Regulation that it supports. As the scope of
the applicable regulatory requirements differ from nation to nation and region to region, the
standard can only support European regulatory requirements to the extent of the scope of the
European Regulation for medical devices (EU) 2017/745.
For the case that small-bore connectors are attached to medical devices or accessories which are
also machinery as defined in the Machinery Directive 2006/42/EC, the relevant Essential Health
and Safety Requirements from Directive 2006/42/EC on machinery are also addressed by this
Document (according to article 1, item 12, of Regulation (EU) 2017/745).
Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive
2006/42/EC on machinery that are addressed by this Document (according to article 1,
item 12, of Regulation (EU) 2017/745)
Essential Health and Clause(s) / sub- Remarks / Notes
Safety Require- ments of clause(s) of this EN
Directive 2006/42/EC
1.5.4 4, 5, 6, 7 This requirement is partially covered in
that misconnections between small-
bore connectors of this series of
standards, which could result in an
unacceptable risk, are made impossible
by design.
Table ZA.3 — Applicable Standards to confer presumption of conformity as described in
this Annex ZA
Column 1 Column 2 Inter- Column 3 Title Column 4
Reference in Clause national Standard Corresponding
2 Edition European
Standard Edition
ISO 80369-1:2018 ISO 80369-1:2018 Small-bore connectors for EN ISO 80369-1:2018
liquids and gases in
healthcare applica- tions —
Part 1: General require-
ments
ISO 80369-20:2015 ISO 80369-20:2015 Small-bore connectors for EN ISO 80369-
liquids and gases in 20:2015
healthcare applica- tions —
Part 20: Common test
methods
ISO 527-1:2019 ed.3 ISO 527-1:2019 ed.3 Determination of tensile EN ISO 527-1:2019
proper- ties — Part 1: ed.3
General principles
ISO 178:2019 ed.6 ISO 178:2019 ed.6 Determination of flexural EN ISO 178:2019
proper- ties
ISO 6892-1:2019 ed.3 ISO 6892-1:2019 ed.3 Metallic materials — EN ISO 6892-1:2019
Tensile
...
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