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EN ISO 16628:2022

(Main)

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document

Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)

Dieses Dokument legt Anforderungen bezüglich Sicherheit, Werkstoffe, Konstruktion und Informationen fest, die mit Tracheobronchialtuben geliefert werden. Diese Geräte werden verwendet, wenn die Isolierung der Atemwege eines oder beider Lungenflügel erforderlich ist.
Trachealtuben mit Bronchusblockern sind vom Anwendungsbereich dieses Dokuments ausgeschlossen.

Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO 16628:2022)

Le présent document spécifie les exigences relatives à la sécurité, aux matériaux, à la conception et aux informations fournies avec les sondes trachéobronchiques. Ces dispositifs sont utilisés lorsqu’il est nécessaire d’isoler les voies aériennes d’un poumon ou des deux poumons.
Les sondes trachéales qui incluent des bloqueurs bronchiques sont exclues du domaine d’application du présent document.

Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)

Ta dokument določa zahteve za varnost, materiale, zasnovo in informacije, ki so priložene traheobronhialnim cevkam. Ti pripomočki se uporabljajo, kadar je treba izolirati dihalne poti enega ali obeh pljučnih
kril.
Trahealne cevke, ki vključujejo bronhialne zaviralce, ne spadajo na področje uporabe tega dokumenta.

General Information

Status
Published
Publication Date
05-Jul-2022
Withdrawal Date
30-Jan-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
06-Jul-2022
Completion Date
06-Jul-2022
Ref Project
SIST EN ISO 16628:2022 - Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)

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SLOVENSKI STANDARD
01-september-2022
Anestezijska in dihalna oprema - Traheobronhialne cevi (ISO 16628:2022)
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
Anästhesie- und Beatmungsgeräte - Tracheobronchialtuben (ISO 16628:2022)
Matériel d’anesthésie et de réanimation respiratoire - Sondes trachéobronchiques (ISO
16628:2022)
Ta slovenski standard je istoveten z: EN ISO 16628:2022
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.

EN ISO 16628
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Tracheobronchial
tubes (ISO 16628:2022)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte -
Sondes trachéobronchiques (ISO 16628:2022) Tracheobronchialtuben (ISO 16628:2022)
This European Standard was approved by CEN on 11 June 2022.

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, 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, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16628:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16628:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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 website.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16628:2022 has been approved by CEN as EN ISO 16628:2022 without any modification.

INTERNATIONAL ISO
STANDARD 16628
Second edition
2022-06
Anaesthetic and respiratory
equipment — Tracheobronchial tubes
Matériel d’anesthésie et de réanimation respiratoire — Sondes
trachéobronchiques
Reference number
ISO 16628:2022(E)
ISO 16628:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 16628:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General . 2
4.2 Safety. 2
5 Materials . 2
5.1 General . 2
5.2 Biological safety testing . 2
6 Design requirements .3
6.1 General . 3
6.2 Designated size . 3
6.3 Dimensions . 3
6.4 Connectors . 3
6.5 Cuffs . 3
6.6 Cuff inflation system . 4
6.7 Bronchial segment . 4
7 Requirements for tracheobronchial tubes supplied sterile . 5
8 Packaging. 5
9 Information supplied by the manufacturer . 6
9.1 General . 6
9.2 Marking . 6
9.2.1 Durability and legibility . 6
9.2.2 Marking on the tracheobronchial tube . 6
9.3 Colour coding . 7
9.4 Marking on the individual packaging or insert . 7
Annex A (informative) Rationale . 8
Annex B (normative) Test method to determine the outside diameter of the bronchial
segment .10
Annex C (normative) Test method to determine the effective inside diameters .11
Bibliography .13
iii
ISO 16628:2022(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 2, Airways and related equipment, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic
equipment, in accordance with the Agreement on technical
...

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h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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