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EN ISO 21969:2006

(Main)

High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)

High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)

2006-04-21 - This document supersedes EN 13221:2000

Flexible Hochdruck-Verbindungen zur Verwendung in Systemen für medizinische Gase (ISO 21969:2005)

1.1   Diese Internationale Norm gilt für flexible Hochdruck-Verbindungen, die zum Anschluss an Gasflaschen oder Flaschenbündel mit einem Nenn-Fülldruck bis zu 25 000 kPa für die Verwendung mit den folgenden medizinischen Gasen vorgesehen sind:
-   Sauerstoff;
-   Distickstoffoxid (Lachgas);
-   Luft für Beatmungszwecke;
-   Helium;
-   Kohlendioxid;
-   Xenon;
-   Gemische der oben genannten Gase;-
-   Luft zum Antrieb chirurgischer Werkzeuge;
-   Stickstoff zum Antrieb chirurgischer Werkzeuge.
1.2   Diese Internationale Norm gilt für flexible Hochdruck-Verbindungen, die für den Anschluss von Gasflaschen oder Flaschenbündel an Gasflaschenanschlusssysteme innerhalb einer Versorgungsquelle für Rohrleitungssysteme für medizinische Gase nach ISO 7396-1 vorgesehen sind.
1.3   Diese Internationale Norm gilt für flexible Hochdruck-Verbindungen, die für den Anschluss einer Gasflasche an die Eingangsöffnung eines mit einem integrierten Druckminderer nach ISO 10524-1 ausgestatteten medizinischen Gerätes (z. B. Anästhesie-Arbeitsplatz oder Beatmungsgerät) vorgesehen sind.
1.4   Diese Internationale Norm gilt nicht für flexible Hochdruck-Verbindungen, die zum Füllen der Gasflaschen vorgesehen sind. Sie gilt auch nicht für Niederdruck-Schlauchsysteme, die in ISO 5359 festgelegt sind.

Raccords flexibles haute pression pour utilisation avec les systèmes de gaz médicaux (ISO 21969:2005)

Visokotlačni prilagodljivi priključki za uporabo medicinskih plinskih sistemov (ISO 21969:2005)

General Information

Status
Withdrawn
Publication Date
20-Jun-2006
Withdrawal Date
31-Oct-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-Nov-2009
Completion Date
01-Nov-2009
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 21969:2006 - High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)

Relations

Replaces
EN 13221:2000 - High-pressure flexible connections for use with medical gases
Effective Date
22-Dec-2008
Replaced By
EN ISO 21969:2009 - High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN 13221:2000
9LVRNRWODþQLSULODJRGOMLYLSULNOMXþNL]DXSRUDERPHGLFLQVNLKSOLQVNLKVLVWHPRY ,62

High-pressure flexible connections for use with medical gas systems (ISO 21969:2005)
Flexible Hochdruck-Verbindungen zur Verwendung in Systemen für medizinische Gase
(ISO 21969:2005)
Raccords flexibles haute pression pour utilisation avec les systemes de gaz médicaux
(ISO 21969:2005)
Ta slovenski standard je istoveten z: EN ISO 21969:2006
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 21969
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.10 Supersedes EN 13221:2000
English Version
High-pressure flexible connections for use with medical gas
systems (ISO 21969:2005)
Raccords flexibles haute pression pour utilisation avec les Flexible Hochdruck-Verbindungen zur Verwendung in
systèmes de gaz médicaux (ISO 21969:2005) Systemen für medizinische Gase (ISO 21969:2005)
This European Standard was approved by CEN on 25 May 2006.
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, Romania,
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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21969:2006: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices .4

Foreword
The text of ISO 21969:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
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 December 2006, and conflicting national standards shall be withdrawn
at the latest by December 2007.
This document supersedes EN 13221:2000.
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, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

Endorsement notice
The text of ISO 21969:2005 has been approved by CEN as EN ISO 21969:2006 without any modifications.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical devices
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 Medical devices
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 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC Medical
devices
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
5 1, 2, 3, 4, 5
5.1 7.1, 7.2, 7.3, 9.3
5.3.1 7.1, 7.3, 9.3
5.3.2 7.1
5.3.3 3, 4
5.3.4 3, 4, 5
5.4.1 7.5, 7.6, 9.1, 12.7.4
5.4.2 7.5, 7.6, 9.1, 12.7.4
5.4.3 4, 12.7.1
5.4.4 3
5.4.5 7.5, 9.3
5.4.6 4, 9.2, 9.3, 12.7.1
5.4.7 4, 9.2, 9.3, 12.7.1
5.4.8 7.1, 9.3
5.4.9 12.7.1
5.4.10 1, 2, 3
5.5.1 7.1, 9.1, 12.7.1
5.5.2 7.1, 7.2, 7.3, 9.3
7.1.1 13.1, 13.2
7.1.2 13.3 a), 13.6 b), 13.3 d), 13.5
7.2 13.2
7.3.1 3, 5, 7.2, 7.6
7.3.2 13.3 b)
8 2, 5, 9.1, 13.1, 13.4, 13.6 c), 13.6
d), 13.3 i), 13.3 j), 13.3 k)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 21969
First edition
2005-03-01
High-pressure flexible connections for
use with medical gas systems
Raccords flexibles haute pression pour utilisation avec les systèmes de
gaz médicaux
Reference number
ISO 21969:2005(E)
©
ISO 2005
ISO 21969:2005(E)
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©  ISO 2005
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
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Web www.iso.org
Published in Switzerland
ii © ISO 2005 – All rights reserved

ISO 21969:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Terminology. 3
5 General requirements . 4
5.1 Safety. 4
5.2 Alternative construction. 4
5.3 Materials. 4
5.4 Design requirements . 4
5.5 Constructional requirements. 6
6 Test methods. 6
6.1 General. 6
6.2 The type tests . 7
7 Marking, colour coding and packaging . 9
7.1 Marking. 9
7.2 Colour coding. 9
7.3 Packaging . 10
8 Information to be supplied by the manufacturer . 10
Annex A (informative) Rationale .12
Bibliography . 13

ISO 21969:2005(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 21969 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
iv © ISO 2005 – All rights reserved

ISO 21969:2005(E)
Introduction
High-pressure flexible connections are widely used within a source of supply of a medical gas pipeline system
to connect cylinders or cylinder bundles to a manifold. They may also be used to connect medical gas
cylinders to the inlet ports of medical equipment fitted with integral pressure regulators suitable for high
pressures.
Because of the high pressures to which these devices are subjected it is important that their characteristics be
specified and tested in a defined manner. It is essential that regular inspection and maintenance be
undertaken to ensure that high-pressure flexible connections continue to meet the requirements of this
International Standard.
This International Standard pays particular attention to:
 use of suitable materials;
 safety (leakage, mechanical strength, bursting pressure and resistance to ignition);
 gas specificity;
 cleanliness;
 type testing;
 marking;
 information to be supplied by the
...

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EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
—    high-frequency oscillatory ventilators (HFOVs);
—    respiratory high flow equipment, which are given in

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
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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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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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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