kSIST FprEN ISO 4135:2021

Anaesthetic and respiratory equipment - Vocabulary (ISO/FDIS 4135:2021)

CEN/BT C082/2011:  DOW = DAV + 36 months

Anästhesie und Beatmungsgeräte - Begriffe (ISO/FDIS 4135:2021)

Matériel d'anesthésie et de réanimation respiratoire - Vocabulaire (ISO/FDIS 4135:2021)

Anestezijska in dihalna oprema - Slovar (ISO/FDIS 4135:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 14-Feb-2020
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 29-Jun-2021
• Due Date: 17-Aug-2021
• Completion Date: 12-Jul-2021
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: FprEN ISO 4135 - Anaesthetic and respiratory equipment - Vocabulary (ISO/FDIS 4135:2021)

RELATIONS

• Revised: SIST EN ISO 4135:2002 - Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
• Effective Date: 01-Feb-2020

Standards Content (sample)

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
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Phone: [phone]
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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

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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

iv © ISO 2019 – All rights reserved
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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:

— 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.

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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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.

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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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
...