EN ISO 5356-1:2015

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)

ISO 5356-1:2015 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. The cones and sockets are therefore not regarded as devices in their own right.
It gives requirements for the following cones and sockets: 8,5 mm and 11,5 mm sizes intended for use in neonatal and paediatric breathing systems; 15 mm and 22 mm sizes intended for general use in breathing systems; 22 mm latching sockets (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.
It does not specify the medical devices and accessories on which these cones and sockets are to be provided.
Requirements for the application of cones and sockets are not included, but are or will be given in the relevant International Standards for specific medical devices and accessories. Requirements for screw-threaded weight-bearing connectors are specified in ISO 5356 2.

Anästhesie- und Beatmungsgeräte - Konische Konnektoren - Teil 1: Männliche und weibliche Konen (ISO 5356-1:2015)

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 legt Anforderungen für folgende konische Konnektoren fest:
-   8,5 mm zur Verwendung in pädiatrischen Atemsystemen;
-   15 mm und 22 mm zur allgemeinen Verwendung in Atemsystemen;
-   22-mm-Schnappkonnektoren (einschließlich Leistungsanforderungen);
-   23 mm zur Verwendung mit Verdampfern, nicht jedoch zur Verwendung in Atemsystemen;
-   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 den entsprechenden 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 5356-1:2015)

l'ISO 5356-1:2015 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 des gaz d'anesthésie et évaporateurs. Les prises mâles et femelles ne sont donc pas considérées comme des dispositifs en soi. Elle énonce les exigences relatives aux raccords mâles et femelles suivants: raccords de diamètres 8,5 mm et 11,5 mm pour les systèmes respiratoires en néonatalogie et en pédiatrie; raccords de diamètres 15 mm et 22 mm à usage général dans les systèmes respiratoires; raccords femelles 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.
Elle ne spécifie pas les appareils médicaux et accessoires auxquels ces raccordements sont destinés.
Les exigences relatives à l'application des raccords mâles et femelles ne sont pas incluses, mais elles font ou feront l'objet de Normes internationales particulières sur des appareils médicaux spécifiques et leurs accessoires. Les exigences relatives aux raccords à vis pouvant supporter un certain poids sont spécifiées dans l'ISO 5356-2.

Anestezijska in dihalna oprema - Konični priključki - 1. del: Vtiči in vtičnice (ISO 5356-1:2015)

General Information

• Status: Published
• Publication Date: 17-Mar-2015
• Withdrawal Date: 29-Sep-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Mar-2015
• Completion Date: 18-Mar-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: SIST EN ISO 5356-1:2015 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)

Relations

• Replaces: EN ISO 5356-1:2004 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2004)
• Effective Date: 25-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2015
1DGRPHãþD
SIST EN ISO 5356-1:2004
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Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
(ISO 5356-1:2015)
Anästhesie- und Beatmungsgeräte - Konische Konnektoren - Teil 1: Männliche und
weibliche Konen (ISO 5356-1:2015)
Matériel d'anesthésie et de réanimation respiratoire - Raccords coniques - Partie 1:
Raccords mâles et femelles (ISO 5356-1:2015)
Ta slovenski standard je istoveten z: EN ISO 5356-1:2015
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.

EUROPEAN STANDARD
EN ISO 5356-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2015
ICS 11.040.10 Supersedes EN ISO 5356-1:2004
English Version
Anaesthetic and respiratory equipment - Conical connectors -
Part 1: Cones and sockets (ISO 5356-1:2015)
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 5356-1:2015)
(ISO 5356-1:2015)
This European Standard was approved by CEN on 10 January 2015.

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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5356-1:2015 E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 5356-1:2015) 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 September 2015, and conflicting national standards shall be
withdrawn at the latest by September 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5356-1:2004.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5356-1:2015 has been approved by CEN as EN ISO 5356-1:2015 without any modification.
INTERNATIONAL ISO
STANDARD 5356-1
Fourth edition
2015-03-15
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 5356-1:2015(E)
©
ISO 2015
ISO 5356-1:2015(E)
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

ISO 5356-1:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Dimensional requirements . 1
3.1 General requirements . 1
3.2 Additional requirements . 3
4 22 mm latching sockets . 4
Annex A (normative) Plug and ring test gauges for cones and sockets made of materials
other than metal . 5
Annex B (normative) Test for security of engagement of 22 mm latching sockets to cones .7
Annex C (normative) Test for leakage from 22 mm latching sockets . 8
Annex D (normative) Drop procedure for 22 mm latching sockets . 9
Annex E (informative) Plug and ring test gauges for cones and sockets made of metal .10
Annex F (informative) Suggested apparatus and methods for testing the security of
engagement of 22 mm latching sockets .12
Bibliography .17
ISO 5356-1:2015(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 (see 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 (see 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
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This fourth edition cancels and replaces the third edition (ISO 5356-1:2004), which has been technically
revised with the following changes:
— harmonizing the terminology used in the text with the title of this part of ISO 5356;
— deleting the definition of 22 mm latching connector because the content is covered by the text of this
part of ISO 5356;
— including 11,5 mm cones and sockets;
— adding the minimum internal diameter for the 30 mm cone and changing the minimum internal
diameter of the 8,5 mm cone from 6,0 mm to 6,25 mm;
— deleting the requirements on reuse of 22 mm latching sockets and cones because this is covered by
the standards for the specific medical devices and accessories;
— making the recess and the shoulder for the 22 mm cone conditional;
— correcting the dimension D for the plug and ring test gauges for 8,5 mm cones and sockets made of
materials other than metal in Annex A of this part of ISO 5356;
— restructuring the document for clarity.
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 2015 – All rights reserved

ISO 5356-1:2015(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 might 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 cones and sockets 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 cones and sockets 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 sockets can be used.
Annex A includes a figure and a table detailing plug and ring test gauges that are used to check cones
and sockets made of materials other than metal. Annex B, Annex C, and Annex D provide test methods
for latching sockets, Annex E includes a figure and table detailing plug and ring test gauges that can be
used to check metal cones and sockets, and Annex F contains recommendations for testing the security
of latching sockets.
Figure 1, detailing the dimensions and tolerances of cones and sockets, has been prepared in accordance
with ISO 3040.
In this document, the following print types are used:
— requirements, compliance with which can be verified, and definitions: roman type;
— notes and examples: smaller roman type;
— test methods: italic type.
INTERNATIONAL STANDARD ISO 5356-1:2015(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 socket
...