SIST EN ISO 4135:2022
(Main)Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and
supplies, related devices and supply systems.
NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to
ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique precoordinated domain-specific term names.
NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and
French), this document gives the equivalent terms in the German language; these are published under the
responsibility of the member body for Germany. However, only the terms and definitions given in the official
languages can be considered as ISO terms and definitions.
Anästhesie und Beatmungsgeräte - Begriffe (ISO 4135:2022)
No scope available
Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire (ISO 4135:2022)
Le présent document établit un vocabulaire des termes utilisés pour le matériel d’anesthésie et de réanimation respiratoire et les fournitures, les dispositifs connexes et les systèmes d’alimentation et/ou de distribution.
NOTE 1 Afin d’éviter des définitions multiples du même terme dans différentes catégories, le présent document tente d’assurer la cohérence par l’inclusion d’une catégorie «générale» et par l’utilisation de spécificateurs de domaine et de désignations uniques de termes pré-coordonnés spécifiques au domaine.
NOTE 2 En complément des termes et définitions dans deux des trois langues officielles de l’ISO (anglais et français), le présent document donne les termes équivalents en allemand; ces termes sont publiés sous la responsabilité du comité membre pour l’Allemagne. Toutefois, seuls les termes et définitions donnés dans les langues officielles peuvent être considérés comme étant des termes et définitions de l’ISO.
Anestezijska in dihalna oprema - Slovar (ISO 4135:2022)
Ta dokument določa slovar izrazov, ki se uporabljajo za anestezijsko in dihalno opremo oziroma potrošni material, povezane pripomočke ter sisteme za oskrbo. OPOMBA 1: Da bi se izognili večkratnim definicijam istega izraza v različnih kategorijah, poskuša ta dokument zagotoviti doslednost z vključitvijo »splošne« kategorije ter z uporabo specifikatorjev domen in edinstvenih vnaprej usklajenih imen izrazov, specifičnih za domeno. OPOMBA 2: Poleg izrazov in definicij, uporabljenih v dveh od treh uradnih jezikov ISO (angleškem in francoskem), ta dokument navaja tudi enakovredne izraze v nemškem jeziku. Ti so objavljeni z odgovornostjo ustreznih organov za Nemčijo. Vendar je kot izraze in definicije ISO mogoče šteti samo tiste, ki so podani v uradnih jezikih.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 4135:2022
01-april-2022
Nadomešča:
SIST EN ISO 4135:2002
Anestezijska in dihalna oprema - Slovar (ISO 4135:2022)
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
Anästhesie und Beatmungsgeräte - Begriffe (ISO 4135:2022)
Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire (ISO 4135:2022)
Ta slovenski standard je istoveten z: EN ISO 4135:2022
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 4135:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 4135:2022
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SIST EN ISO 4135:2022
EN ISO 4135
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 01.040.11; 11.040.10 Supersedes EN ISO 4135:2001
English Version
Anaesthetic and respiratory equipment - Vocabulary (ISO
4135:2022)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie und Beatmungsgeräte - Begriffe (ISO
Vocabulaire (ISO 4135:2022) 4135:2022)
This European Standard was approved by CEN on 22 August 2021.
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 4135:2022 E
worldwide for CEN national Members.
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SIST EN ISO 4135:2022
EN ISO 4135:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 4135:2022
EN ISO 4135:2022 (E)
European foreword
This document (EN ISO 4135:2022) 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 August 2022, and conflicting national standards shall
be withdrawn at the latest by August 2022.
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.
This document supersedes EN ISO 4135:2001.
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 4135:2022 has been approved by CEN as EN ISO 4135:2022 without any modification.
3
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SIST EN ISO 4135:2022
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SIST EN ISO 4135:2022
INTERNATIONAL ISO
STANDARD 4135
Fourth edition
2022-01
Anaesthetic and respiratory
equipment — Vocabulary
Anästhesie und Beatmungsgeräte — Begriffe
Matériel d'anesthésie et de réanimation respiratoire — Vocabulaire
Reference number
ISO 4135:2022(E)
© ISO 2022
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2022 – All rights reserved
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General concepts . 1
3.1.1 Properties of gases and materials . 1
3.1.2 Properties of equipment . 4
3.1.3 Metrology concepts . 5
3.1.4 Equipment components. 7
3.1.5 Physiological terms . 14
3.1.6 Use environment and workflow . 16
3.2 Medical gas supply systems . 18
3.2.1 Pipeline systems . 18
3.2.2 Terminal units . 21
3.2.3 Low-pressure hose assemblies for use with medical gases .22
3.2.4 Pressure regulators .22
3.2.5 Gas cylinders and accessories . 23
3.3 Anaesthetic machines and workstations . 24
3.3.1 General terms . 24
3.3.2 Components . 25
3.4 Ventilators and resuscitators .26
3.4.1 General terms . 26
3.4.2 Ports .28
3.4.3 Pressures . .28
3.4.4 Flowrates .28
3.5 Oxygen therapy delivery systems .29
3.5.1 Liquid oxygen systems .29
3.6 Breathing systems .29
3.6.1 General terms and classification .29
3.6.2 Adaptors . . 31
3.6.3 Valves . 31
3.7 Humidifiers, nebulizers and moisture exchangers . 32
3.7.1 General terms . 32
3.7.2 Humidifiers . 32
3.7.3 Nebulizers. 33
3.7.4 Heat and moisture exchangers .34
3.8 Airways, tracheal tubes, tracheostomy tubes and intubation equipment .34
3.8.1 General .34
3.8.2 Pharyngeal airway . 35
3.8.3 Tracheal tubes . 35
3.8.4 Bronchial tubes and blockers . 37
3.8.5 Tracheostomy tubes . 37
3.8.6 Masks and cannulae .38
3.8.7 Voice prostheses . 39
3.8.8 Laryngoscopes . 39
3.9 Anaesthetic gas scavenging and plume evacuation systems .39
3.9.1 General terms .39
3.10 Suction devices . 43
3.10.1 General terms . 43
3.10.2 Suction equipment .44
3.10.3 Suction catheters for the respiratory tract . .44
3.11 Monitoring . 45
iii
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
3.11.1 General terms . 45
3.11.2 Gas monitors .46
3.11.3 Pulse oximeters . 47
3.11.4 Thermometers .48
3.11.5 ECG equipment .48
3.11.6 Sphygmomanometers . 51
3.11.7 Transcutaneous gas monitors . 52
Bibliography .53
Index .54
iv
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SIST EN ISO 4135:2022
ISO 4135:2022(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 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 4, Vocabulary and semantics, 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 cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 4135:2001), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Deletion of terms that are no longer relevant to International Standards prepared by ISO/TC 121, or
that are defined in more widely applicable International Standards, such as ISO 14971.
— Deletion of terms that are specific to lung ventilators and that are covered in ISO 19223.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
Introduction
The primary objective for this document has been to facilitate consistent use of terminology across all
the standards relevant to manufacturers, test laboratories and regulatory agencies with an interest in
equipment for use in anaesthesiology and respiratory care.
Terms defined in ISO 19223 have been included in this document where they have applicability outside
the scope of mechanical ventilation.
EXAMPLE 1 Airway pressure is included in this document because it has applicability in fields such as
pulmonary function testing.
EXAMPLE 2 Airway resistance is not included in this document because the only context of use of this term is
within standards for lung ventilators, for which ISO 19223 is an appropriate source.
Particular emphasis has been placed on the identification of instances where the same term is used for
different concepts, or where the same concept is identified by different terms.
The terms, names and acronyms listed in this document have been described in a manner that
formalizes their interpretation to the extent that it minimizes ambiguity and provides a rigid usage
discipline for formal data handling and informatics, whilst retaining phraseology that is suitable for
user instructions and clinical dialog.
In the application of the vocabulary of this document, the full term should always be used wherever
any ambiguity might arise from use of an abbreviated term and where there is no trade-off with
conciseness, for example, in the formulation of data bases. However, in many applications the context of
use may make some of the parts of a compound preferred term redundant, in which case abbreviations,
symbols and permitted terms may be used, as appropriate.
The vocabulary of this document is primarily arranged in a systematic order, with a secondary
alphabetical order. An alphabetical index of the terms defined is provided at the end of this document.
For terms that have different definitions in differing contexts, the definition context is specified in <>
before the definition.
This document is a “controlled vocabulary”, which includes “pre-coordinated terms”. It is expected
that users of this document may also create “post-coordinated terms” by a process of concatenation as
appropriate to the field of use. Within the field of terminology standards, a pre-coordinated term is a
verbal designation of a concept with more than one root that can be split morphologically into separate
components and which is predefined in a controlled vocabulary, for example minute volume and
pressure-limiting valve, while a post-coordinated term is a verbal designation of a concept with more
than one root, created by a user by combining terms from controlled vocabularies. An example of this
would be supraglottic airway device, which can be created by combining the two individually defined
terms supraglottic and airway device.
vi
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SIST EN ISO 4135:2022
INTERNATIONAL STANDARD ISO 4135:2022(E)
Anaesthetic and respiratory equipment — Vocabulary
1 Scope
This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and
supplies, related devices and supply systems.
NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to
ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-
coordinated domain-specific term names.
NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and
French), this document gives the equivalent terms in the German language; these are published under the
responsibility of the member body for Germany. However, only the terms and definitions given in the official
languages can be considered as ISO terms and definitions.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 General concepts
3.1.1 Properties of gases and materials
3.1.1.1
absolute humidity
mass of water vapour present in a unit volume of gas
Note 1 to entry: In respiratory applications absolute humidity is commonly represented in units of milligrams per
litre or grams per cubic metre, with volume expressed at BPTS condition.
Note 2 to entry: See also relative humidity (3.1.2.4).
3.1.1.2
adiabatic compression
compression process that occurs without transfer of heat into or out of a system
3.1.1.3
aerosol
suspension of liquid or solid particles in a gas
1
© ISO 2022 – All rights reserved
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
3.1.1.4
air for driving surgical tools
natural or synthetic mixture of gases, mainly composed of oxygen and nitrogen in specified proportions,
with defined limits for the concentration of contaminants, and intended to act as a power source for
surgical tools
3.1.1.5
anaesthetic gas
gas, which may be the vapour of a volatile anaesthetic agent, or mixture of gases, used in anaesthesia
Note 1 to entry: In parts of an anaesthetic breathing system (3.6.1.8), anaesthetic gas includes gases exhaled by
the patient.
3.1.1.6
auto-ignition temperature
temperature at which a material will spontaneously ignite under specified conditions
3.1.1.7
body temperature and pressure saturated
BTPS
ambient atmospheric pressure, at a temperature of 37 °C, and at a relative humidity (3.1.2.4) of 100 %
3.1.1.8
standard temperature and pressure dry
STPD
pressure of 101,325 kPa at a temperature of 20 °C, dry
3.1.1.9
carrier gas
respirable gas that conveys a substance or substances to the patient
EXAMPLE Medical air (3.1.1.18) used to convey a bronchodilatory drug.
3.1.1.10
carrier gas
respirable gas that conveys one or more anaesthetic gases (3.1.1.5) to the patient
EXAMPLE Ambient air and oxygen (3.1.1.21) mixture in a draw-over vaporiser (3.3.2.3).
3.1.1.11
combustion
rapid oxidation to produce heat and light
3.1.1.12
compliance
change in volume of gas per unit pressure change within an enclosed space
Note 1 to entry: It is deprecated to include the measurement conditions into the definition of compliance; in
general compliance may be expressed at any specified measurement condition.
Note 2 to entry: ISO 19223 provides definitions for pulmonary compliance, respiratory system compliance, static
compliance and dynamic compliance, all of which relate to the patient. Various other standards from ISO/TC 121
reference compliance with respect to items of equipment such as breathing tubes (3.1.4.4) and reservoir bags.
3.1.1.13
delivered gas temperature
temperature of the gas, or aerosol (3.1.1.3) or both, being delivered to a patient, referenced to the
patient-connection port (3.1.4.41)
2
© ISO 2022 – All rights reserved
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SIST EN ISO 4135:2022
ISO 4135:2022(E)
3.1.1.14
delivered oxygen concentration
concentration of oxygen in the gas delivered at a specified location
EXAMPLE In a closed anaesthetic breathing system (3.6.1.8), 100 % oxygen can be added to the breathing
system (3.6.1.1) to match the patient’s oxygen consumption, with the respiratory gas monitor (3.11.2.1) at the
patient-connection port (3.1.4.41) measuring a much lower value for FiO (3.1.1.15).
2
3.1.1.15
FiO
2
fraction of inspired oxygen
concentration of oxygen in the gas inspired by a patient
Note 1 to entry: The measurement site for FiO should be specified by the equipment manufacturer but should be
2
referenced to the concentration of oxygen in the gas that is intended to be inspired.
EXAMPLE In a closed anaesthetic breathing system (3.6.1.8), 100 % oxygen can be added to the breathing
system (3.6.1.1) to match the patient’s oxygen consumption, with the respiratory gas monitor (3.11.2.1) at the
patient-connection port (3.1.4.41) measuring a much lower value for FiO .
2
3.1.1.16
fresh gas
respirable gas delivered to a breathing system (3.6.1.1)
Note 1 to entry: In a circle breathing system (3.6.1.8.1), the fresh gas is all respirable gas delivered into the circle
breathing system (including anaesthetic gases (3.1.1.5) and vapours). This can include oxygen (3.1.1.21) or air
delivered into an anaesthetic vaporiser (3.3.2.2), and it can also include the vapour generated by an anaesthetic
vaporiser.
Note 2 to entry: In an open breathing system (3.6.1.1), the fresh gas is all respirable gas delivered into the breathing
system (which can be at any point within the breathing system).
3.1.1.17
gas for medicinal use
gas or mixture of gases that can be used either with a view to restore, correct or modify physiological
functions by exerting a pharmacological, immunological or metabolic action, or to make a medica
...
SLOVENSKI STANDARD
oSIST prEN ISO 4135:2020
01-februar-2020
Anestezijska in dihalna oprema - Slovar in semantika (ISO/DIS 4135:2019)
Anaesthetic and respiratory equipment - Vocabulary and semantics (ISO/DIS 4135:2019)
Anästhesie- und Beatmungsgeräte - Begriffe (ISO/DIS 4135:2019)
Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire (ISO/DIS 4135:2019)
Ta slovenski standard je istoveten z: prEN ISO 4135
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 4135:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 4135:2020
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oSIST prEN ISO 4135:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 4135
ISO/TC 121/SC 4 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-11-26 2020-02-18
Anaesthetic and respiratory equipment — Vocabulary and
semantics
Matériel d'anesthésie et de réanimation respiratoire — Vocabulaire
ICS: 11.040.10; 01.040.11
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 4135:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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oSIST prEN ISO 4135:2020
ISO/DIS 4135:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 4135:2020
ISO/DIS 4135:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General Concepts . 1
3.1.1 Properties of gases and materials . 1
3.1.2 Properties of equipment . 4
3.1.3 Metrology concepts . 5
3.1.4 Equipment components . 7
3.1.5 Physiological terms . .13
3.1.6 Use environment and workflow .15
3.2 Medical Gas Supply Systems .16
3.2.1 Pipeline systems .16
3.2.2 Terminal units .19
3.2.3 Low-pressure hose assemblies for use with medical gases.20
3.2.4 Pressure regulators .21
3.2.5 Gas cylinders and accessories .21
3.3 Anaesthetic machines and workstations for use with humans .22
3.3.1 General terms .22
3.3.2 Components .23
3.4 Ventilators and resuscitators .24
3.4.1 General terms .24
3.4.2 Ports .26
3.4.3 Pressures .26
3.4.4 Flowrates .27
3.5 Oxygen therapy delivery systems .27
3.5.1 Liquid Oxygen systems .27
3.6 Breathing systems .27
3.6.1 General terms and classification .27
3.6.2 Ports, connectors and adaptors .29
3.6.3 Valves .29
3.7 Humidifiers, nebulizers and moisture exchangers .30
3.7.1 General terms .30
3.7.2 Humidifiers .30
3.7.3 Nebulizers .31
3.7.4 Heat and moisture exchangers (HME) .32
3.8 Airways, tracheal tubes, tracheostomy tubes and intubation equipment .32
3.8.1 General.32
3.8.2 Pharyngeal airway .33
3.8.3 Tracheal tubes .33
3.8.4 Bronchial tubes and blockers .35
3.8.5 Tracheostomy tubes .35
3.8.6 Masks and cannulae .36
3.8.7 Laryngoscopes .36
3.9 Anaesthetic gas scavenging and plume evacuation systems .37
3.9.1 General terms .37
3.10 Suction devices .39
3.10.1 General terms .39
3.10.2 Suction equipment .40
3.10.3 Suction catheters for the respiratory tract .41
3.11 Monitoring .41
3.11.1 General terms .41
© ISO 2019 – All rights reserved iii
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oSIST prEN ISO 4135:2020
ISO/DIS 4135:2019(E)
3.11.2 Respiratory gas monitors .42
3.11.3 Pulse oximeters .43
3.11.4 Thermometers .44
3.11.5 ECG equipment .44
3.11.6 Sphygmomanometers .47
3.11.7 Transcutaneous Gas Monitors .48
Bibliography .49
Terminology — Alphabetized index of defined terms .50
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oSIST prEN ISO 4135:2020
ISO/DIS 4135:2019(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 4, Vocabulary and semantics, WG1 Respiratory equipment vocabulary.
This fourth edition cancels and replaces the third edition (ISO 4135:2001), which has been technically
revised.
The main changes compared to the previous edition are as follows:
rd
— Deletion of terms from ISO 4135 3 edition that are no longer relevant to standards prepared by
ISO/TC 121, or that are defined in more widely applicable standards such as ISO 14971.
— Deletion of terms that are specific to lung ventilators and that are covered in ISO 19223, and that are
not relevant outside of the scope of that standard.
— Incorporation of terms from ISO/TC 121 Standards that are applicable beyond their current scope.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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oSIST prEN ISO 4135:2020
ISO/DIS 4135:2019(E)
Introduction
The primary objective for ISO 4135 has been to facilitate consistent use of terminology across all the
Standards relevant to manufacturers, test laboratories, and regulatory agencies with an interest in
equipment for use in anaesthesiology and respiratory care.
rd
Since the publication of the 3 edition of ISO 4135 in 2001, many new and updated standards have been
published under the auspices of ISO/TC 121. In many cases, terms defined in ISO 4135 have not been
found sufficient for the purposes of these standards, resulting in terms being redefined in different
standards, or new terms created, such that users of the standards may be confused as to the meaning.
In preparation for this new edition, SC 4 created a working group tasked with reviewing all the terms
defined in ISO/TC 121 documents. This new edition is intended to address several objectives:
a) Deletion of terms in the 2001 edition of ISO 4135 that no longer fulfil a purpose, or that are now
included in ISO 19223 (where these are not used outside the scope of that standard);
b) Addition of terms from other TC121 standards where these may be of value across multiple
standards;
c) Encouragement of consistent use of terminology across TC121 standards, in order to minimize the
potential for stakeholders to misunderstand intent.
In preparation of this edition of ISO 4135 it became apparent that many terms are defined in standards
applicable to medical equipment more widely than the scope of TC121, and that redefining these terms
in a domain-specific terminology or in a particular standard can lead to confusion when users of the
standard are familiar with the more generally applicable terminologies.
In line with guidance in ISO/IEC Directives, Part 2, Principles and rules for the structure and drafting of
ISO and IEC documents, subclause 16.5.5, this document does not include a number of terms that have
previously been defined in ISO TC121 deliverables, and yet are also defined in more general ISO/IEC
sources. These terms fall within scope of the guidance in ISO/IEC Directives Part 2:
“Common terms, which a qualified user of the document will already know, should not be
defined.”
[SOURCE: ISO/IEC Directives, Part 2, subclause 16.5.5]
Sub-committees of ISO TC121 and their working groups are recommended to reference terms in one of
these sources rather than including a definition within their deliverable.
The specific list of sources that this Working Group determined to be “widely known to a qualified
user” of an ISO TC121 deliverable comprises the following:
ISO Guidance and standards applicable to all medical equipment
[1]
— ISO/IEC Guide 63 ,
[2]
— ISO 14971
[3]
— ISO 16142-1 .
IEC standards applicable to all medical electrical equipment (or for all within a specified use
environment)
[4]
— IEC 60601-1 ,
[5]
— IEC 60601-1-2
[6]
— IEC 60601-1-6
[7]
— IEC 60601-1-8
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oSIST prEN ISO 4135:2020
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[8]
— IEC 60601-1-9
[9]
— IEC 60601-1-10
[10]
— IEC 60601-1-11
[11]
— IEC 60601-1-12
[12]
— IEC 62366-1
It has not proven possible to include a list of terms that are defined in these sources into this document.
BOX NOTE
SC4 intends to publish a white paper “Terminologies for Respiratory and Anaesthetic Equipment
Standards” prior to the final publication of this edition of ISO 4135.
A number of terms previously defined in ISO 4135 or in other TC 121 standards, particularly those
for different categories of lung ventilators and anaesthetic workstations, are now provided in
[13]
ISO 19223:2019. These are freely available on the ISO online browsing platform,
ISO Online browsing platform: available at https: //www .iso .org/obp
Terms defined in ISO 19223 have not been included into this edition of ISO 4135 unless they have
applicability outside the scope of mechanical ventilation.
EXAMPLE 1 airway pressure is included in this edition of ISO 4135 because it has applicability in fields such as
pulmonary function testing.
EXAMPLE 2 airway resistance is not included in this edition of ISO 4135 because the only context of use of this
term is within standards for lung ventilators, for which ISO 19223 is an appropriate source.
Particular emphasis has been placed on the identification of instances where the same term is used for
different concepts, or where the same concept is identified by different terms.
This last point is particularly relevant for test laboratories, and for manufacturers using standards
from several different ISO TC121 SCs, or TC121 standards alongside IEC TC62 standards. When multiple
definitions exist, and particularly when terms in the general standard or collaterals are redefined in
particular standards, it is all too easy for the user of a standard to reference the wrong definition, and
hence misconstrue requirements.
In some cases, terms were provided in different sections of ISO 4135 ed. 3, with different definitions.
We have amended the categorization, and in some cases amended term names, in order to avoid any
instances of terms with distinct definitions.
The terms, names and acronyms listed in this Standard have been described in a manner that formalizes
their interpretation to the extent that it minimizes ambiguity and provides a rigid usage discipline for
formal data handling and informatics, whilst retaining phraseology that is suitable for user instructions
and clinical dialog.
In the application of the vocabulary of this International Standard, the full term should always be
used wherever any ambiguity must be avoided and where there is no trade-off with conciseness, for
example, in the formulation of data bases. However, in many applications the context of use may make
some of the parts of a compound preferred term redundant, in which case abbreviations, symbols and
permitted terms may be used, as appropriate.
Vocabulary and terminology standards are required by ISO to be prepared considering the guidance of
ISO 704, Terminology work - Principles and methods, ISO 10241-1, Terminological entries in standards
- Part 1: General requirements and examples of presentation, and the ISO/IEC Directives, Part 2, 2011
-- Rules for the structure and drafting of International Standards.
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oSIST prEN ISO 4135:2020
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The following concepts extracted from ISO 704 were considered to be of particular relevance to the
formatting of the vocabulary in this International Standard:
Standardized terminologies should reflect a coherent terminological system that corresponds
to the concept system of the subject field in question. The terminology defined in an Interna-
tional Standard should be precise and lead to increased clarity in communication.
A primary function of a standardised terminology is to indicate preferred, admitted and dep-
recated terms. A term recommended by a technical committee shall be considered a preferred
term whereas an admitted term shall represent an acceptable synonym for a preferred term.
Deprecated terms are terms that have been rejected. Terms are rejected or deprecated for a
number of reasons. A term may be a synonym for the preferred term but is deprecated in the
interests of monosemy (having a single meaning). Alternatively a term may be flawed, inaccu-
rate or may be used with a different definition.
[14]
[SOURCE: ISO 704 ]
In accordance with the ISO 10241-1:2011 Clause 6.4.4, the definitions of terms are intentional definitions.
Such definitions are required to consist of a single phrase specifying the concept being designated, and
if possible, to reflect the position of the concept in the concept system; containing only information that
makes the concept unique. A definition given without an indication of its applicability is to be taken as
representing the general meaning of the term. Any additional descriptive information deemed necessary
is included in notes to entry or in examples. Notes to entry follow different rules from notes integrated
into other text; they provide additional information that supplements the terminological data.
The terminological entries hereunder are formatted in accordance with the current ISO rules for the
presentation of terminology standards. The vocabulary of this International Standard is primarily
arranged in a systematic order, with a secondary alphabetical order. An alphabetical list of terms is
provided at the end of this document.
For terms that have different definitions in differing contexts, the definition context is specified in <>
before the definition.
This document is a “controlled vocabulary”, which includes “pre-coordinated terms”. It is expected
that users of this standard may also create “post-coordinated terms” by a process of concatenation as
appropriate to the field of use.
pre-coordinated term
verbal designation of a concept with more than one root that can be split morphologically into separate
components, which is predefined in a controlled vocabulary
EXAMPLES: minute volume and pressure-limiting valve
post-coordinated term
verbal designation of a concept with more than one root, created by a user by combining terms from
controlled vocabularies
EXAMPLE supraglottic airway device can be created by combining the two individually defined terms
supraglottic and airway device
controlled vocabulary
standardized and organized arrangements of terms and their definitions related to one or more
subject fields
Different jurisdictions use different distinct definitions for patient populations based on age and
weight. In this standard an attempt has been made to define terms for patient groups, recognizing that
it is impossible to align with regulations in all jurisdictions. Where a particular standard has a need to
refer to a patient cohort by weight, this should be specified explicitly.
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oSIST prEN ISO 4135:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 4135:2019(E)
Anaesthetic and respiratory equipment — Vocabulary and
semantics
1 Scope
This International Standard establishes a vocabulary of terms used for anaesthetic and respiratory
equipment and supplies, related devices and supply systems.
Note 1 to entry This International Standard is based on standards and drafts which have been produced by
ISO/TC 121 and CEN/TC 215.
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Note 2 to entry Contrary to the policy in ISO 4135 3 edition of allowing multiple definitions of the same term
in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and
by use of domain specifiers and unique pre-coordinated domain-specific term names.
Note 3 to entry In addition to terms and definitions used in two of the three official ISO languages (English and
French), this International Standard gives the equivalent terms in the German language; these are published
under the responsibility of the member body for Germany. However, only the terms and definitions given in the
official languages can be considered as ISO terms and definitions.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
None.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1 General Concepts
3.1.1 Properties of gases and materials
3.1.1.1
absolute humidity
mass of water vapour present in a unit volume of moist gas
Note 1 to entry: In respiratory applications absolute humidity is commonly represented in units of milligrams per
litre or grams per cubic metre.
Note 2 to entry: See also relative humidity (3.1.2.4)
3.1.1.2
adiabatic compression
compression process that occurs without transfer of heat into or out of a system
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oSIST prEN ISO 4135:2020
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3.1.1.3
aerosol
suspension of liquid or solid particles in a gas
3.1.1.4
air for driving surgical tools
natural or synthetic mixture of gases, mainly composed of oxygen and nitrogen in specified proportions,
with defined limits for the concentration of contaminants, intended f
...
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