SIST EN ISO 5356-1:2004

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)

This Part of this European Standard specifies dimensional and gauging requirements for cones and sockets and performance requirements for latching connectors intended for use in medical devices, e.g. in breathing systems, anaesthetic gas scavenging systems and vaporizers.  This European Standard does not specify the medical devices and accessories on which these connectors are to be provided.   NOTE 1: It is expected that requirements on the use of suitable materials and for the application of this standard will be included in particular standards for specific medical devices and accessories.   NOTE 2: Requirements for screw-threaded weight-bearing conical connectors are specified in Part 2 of this standard.

Anästhesie- und Beatmungsgeräte - Konische Konnektoren - Teil 1: Männliche und weibliche Konen (ISO 5356-1:2004)

Dieser Teil von ISO 5356 legt Anforderungen an Maße und Lehren für männliche und weibliche Konen fest, die für Anschlüsse bei Anästhesie- und Beatmungsgeräten verwendet werden, z. B. in Atemsystemen, Anästhesiegas-Fortleitungssystemen und Verdampfern.
Dieser Teil von ISO 5356-1 legt Anforderungen für folgende konische Konnektoren fest:
3 8,5 mm zur Verwendung in pädiatrischen Atemsystemen;
3 15 mm und 22 mm zur allgemeinen Verwendung in Atemsystemen;
3 22-mm-Schnappkonnektoren (einschließlich Leistungsanforderungen);
3 23 mm zur Verwendung mit Verdampfern, nicht jedoch zur Verwendung in Atemsystemen;
3 30 mm zum Anschluss eines Atemsystems an ein Anästhesiegas-Fortleitungssystem.
Die medizinischen Geräte und das Zubehör, für die/das diese Anschlüsse vorgesehen sind, werden nicht in diesem Teil von ISO 5356 festgelegt.
Anforderungen an die Verwendung von konischen Konnektoren sind nicht Bestandteil von diesem Teil von ISO 5356; diese Anforderungen sind jedoch in speziellen Internationalen Normen für bestimmte medizinische Geräte und medizinisches Zubehör enthalten bzw. werden in diese aufgenommen.
ANMERKUNG      Anforderungen an gewichtstragende konische Konnektoren mit Schraubgewinde sind in ISO 5356-2 festgelegt.

Matériel d'anesthésie et de réanimation respiratoire - Raccords coniques - Partie 1: Raccords mâles et femelles (ISO 5356-1:2004)

L'ISO 5356-1:2004 spécifie les exigences dimensionnelles et les calibres des raccords mâles et femelles destinés à être raccordés au matériel respiratoire et d'anesthésie, tels que les systèmes respiratoires, systèmes d'évacuation de gaz d'anesthésie en excès et évaporateurs.
L'ISO 5356-1:2004 énonce les exigences relatives aux raccords coniques suivants:
raccords de diamètre 8,5 mm pour les systèmes respiratoires en pédiatrie;
raccords de diamètres 15 mm et 22 mm à usage général dans les systèmes respiratoires;
raccords avec système de blocage de diamètre 22 mm (avec exigences de performance);
raccords de diamètre 23 mm destinés à l'emploi avec les évaporateurs, mais non à l'emploi dans les systèmes respiratoires;
raccords de diamètre 30 mm destinés au raccordement d'un système respiratoire à un système d'évacuation de gaz d'anesthésie.
L'ISO 5356-1:2004 ne spécifie pas les appareils médicaux et accessoires auxquels ces raccordements sont destinés.
Les exigences relatives à l'application des raccords coniques ne sont pas incluses dans l'ISO 5356-1:2004, mais elles font ou feront l'objet de Normes internationales particulières sur des appareils médicaux spécifiques et leurs accessoires.
NOTE Les exigences relatives aux raccords coniques à vis pouvant supporter un certain poids sont spécifiées dans l'ISO 5356-2.

Anestezijska in respiratorna oprema - Konični priključki - 1. del: Vtikači in vtičnice (ISO 5356-1:2004)

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2004
• Withdrawal Date: 13-May-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 14-May-2015
• Due Date: 06-Jun-2015
• Completion Date: 14-May-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 5356-1:2004 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)

Relations

• Replaced By: SIST EN ISO 5356-1:2015 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
• Effective Date: 01-Jun-2015
• Replaces: SIST EN 1281-1:2000 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• Effective Date: 01-Nov-2004
• Replaces: SIST EN 1281-1:2000/A1:2000 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• Effective Date: 01-Nov-2004

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5356-1:2004
01-november-2004
1DGRPHãþD
SIST EN 1281-1:2000
SIST EN 1281-1:2000/A1:2000
$QHVWH]LMVNDLQUHVSLUDWRUQDRSUHPD.RQLþQLSULNOMXþNLGHO9WLNDþLLQYWLþQLFH
,62
Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
(ISO 5356-1:2004)
Anästhesie- und Beatmungsgeräte - Konische Konnektoren - Teil 1: Männliche und
weibliche Konen (ISO 5356-1:2004)
Matériel d'anesthésie et de réanimation respiratoire - Raccords coniques - Partie 1:
Raccords mâles et femelles (ISO 5356-1:2004)
Ta slovenski standard je istoveten z: EN ISO 5356-1:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 5356-1:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 5356-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.10 Supersedes EN 1281-1:1997
English version
Anaesthetic and respiratory equipment - Conical connectors -
Part 1: Cones and sockets (ISO 5356-1:2004)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Konische Konnektoren
Raccords coniques - Partie 1: Raccords mâles et femelles - Teil 1: Männliche und weibliche Konen (ISO 5356-1:2004)
(ISO 5356-1:2004)
This European Standard was approved by CEN on 1 April 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5356-1:2004: E
worldwide for CEN national Members.

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EN ISO 5356-1:2004 (E)





Foreword


This document (EN ISO 5356-1:2004) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.

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 November 2004, and conflicting national
standards shall be withdrawn at the latest by November 2004.

This document supersedes EN 1281-1:1997.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU
Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 5356-1:2004 has been approved by CEN as EN ISO 5356-1:2004 without any
modifications.
2

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EN ISO 5356-1:2004 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC

This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC.

Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
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 Essential
Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.


Table ZA.1 – Correspondence between this European Standard and EU Directives

Clause/subclause of this European Corresponding essential requirements of Comments
Standard Directive 93/42/EEC
4 1, 2, 7.5, 7.6, 9.1
5 1, 2, 7.5, 7.6, 9.1
6 1, 2, 4, 7.5, 7.6, 9.1

3

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INTERNATIONAL ISO
STANDARD 5356-1
Third edition
2004-05-15


Anaesthetic and respiratory equipment —
Conical connectors —
Part 1:
Cones and sockets
Matériel d'anesthésie et de réanimation respiratoire — Raccords
coniques —
Partie 1: Raccords mâles et femelles




Reference number
ISO 5356-1:2004(E)
©
ISO 2004

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ISO 5356-1:2004(E)
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ii © ISO 2004 – All rights reserved

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ISO 5356-1:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Conical connectors made of metal . 2
4.1 General requirements. 2
4.2 Additional requirements for male conical connectors of 22 mm size. 2
4.3 Additional requirements for conical connectors of 8,5 mm size . 4
5 Conical connectors made of materials other than metal. 4
5.1 General requirements. 4
5.2 Additional requirements for conical connectors of 22 mm size . 4
5.3 Additional requirements for conical connectors of 8,5 mm size . 4
6 22 mm latching connectors. 4
Annex A (normative) Plug and ring test gauges for conical connectors made of materials other
than metal . 5
Annex B (normative) Test for security of engagement of 22 mm latching connector to male
conical connector . 7
Annex C (normative) Test for leakage from 22 mm latching connectors. 8
Annex D (normative) Drop procedure for 22 mm latching connectors. 9
Annex E (informative) Plug and ring test gauges for conical connectors made of metal . 10
Annex F (informative) Suggested apparatus and methods for testing the security of engagement
of 22 mm latching connectors . 12
Bibliography . 16

© ISO 2004 – All rights reserved iii

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ISO 5356-1:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 5356-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This third edition cancels and replaces the second edition (ISO 5356-1:1996), which has been technically
revised. The major differences are the inclusion of 8,5 mm size connectors and some minor corrections to the
figures and tables.
ISO 5356 consists of the following parts, under the general title Anaesthetic and respiratory equipment —
Conical connectors:
 Part 1: Cones and sockets
 Part 2: Screw-threaded weight-bearing connectors
iv © ISO 2004 – All rights reserved

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ISO 5356-1:2004(E)
Introduction
In clinical practice, several breathing attachments used in anaesthetic and respiratory equipment may have to
be joined together to provide a suitable breathing system. Items of medical equipment, such as a humidifier or
a spirometer, are often incorporated into the breathing system which may also be connected to an
anaesthetic-gas scavenging system. Connections for these purposes are usually cone and socket joints, and
a lack of standardization of these connections has given rise to problems of interchangeability when
connecting equipment made by different manufacturers. This part of ISO 5356 specifies the requirements and
dimensions for conical connectors used in anaesthetic and respiratory equipment.
An important consideration is that conical connections need to be secure but nevertheless disconnectable by
the operator. The use of connectors meeting the requirements of this part of ISO 5356 will not necessarily
prevent them being disconnected accidentally. To minimize the risk of 22 mm connectors being accidentally
disconnected, latching connectors can be used.
Annex A includes a figure and a table detailing plug and ring test gauges that are used to check conical
connectors made of materials other than metal. Annexes B, C and D provide test methods for latching
connectors, Annex E includes a figure and table detailing plug and ring test gauges that may be used to check
metal conical connectors, and Annex F contains recommendations for testing security of latching connectors.
Figure 1, detailing the dimensions and tolerances of metal conical connectors, has been prepared in
accordance with ISO 3040.

© ISO 2004 – All rights reserved v

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INTERNATIONAL STANDARD ISO 5356-1:2004(E)

Anaesthetic and respiratory equipment — Conical
connectors —
Part 1:
Cones and sockets
1 Scope
This part of ISO 5356 specifies dimensional and gauging requirements for cones and sockets intended for
connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic-gas scavenging
systems and vaporizers.
This part of ISO 5356 gives requirements for the following conical connectors:
 8,5 mm size intended for use in paediatric breathing systems;
 15 mm and 22 mm sizes intended for general use in breathing systems;
 22 mm latching connectors (including performance requirements);
 23 mm size intended for use with vaporizers, but not for use in breathing systems;
 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system.
This part of ISO 5356 does not specify the medical devices and accessories on which these connections are
to be provided.
Requirements for the application of conical connectors are not included in this part of ISO 5356, but are or will
be given in the relevant International Standards for specific medical devices and accessories.
NOTE Requirements for screw-threaded weight-bearing conical connectors are specified in ISO 5356-2.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety, including
Amendment 1:1991 and Amendment 2:1995
© ISO 2004 – All rights res
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