SIST EN ISO 80601-2-74:2020

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)

Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2017)

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

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SLOVENSKI STANDARD
01-april-2020
Nadomešča:
SIST EN ISO 8185:2009
Medicinska električna oprema - 2-74. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za vlažilne sisteme dihalne opreme (ISO 80601-2-74:2017)
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)
Medizinische elektrische Geräte - Teil 2-74: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anfeuchtersystemen (ISO
80601-2-74:2017)
Appareils électromédicaux - Partie 2-74: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'humidification respiratoire (ISO
80601-2-74:2017)
Ta slovenski standard je istoveten z: EN ISO 80601-2-74:2020
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.

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EN ISO 80601-2-74
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2020
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-74: Particular
requirements for basic safety and essential performance of
respiratory humidifying equipment (ISO 80601-2-
74:2017)
Appareils électromédicaux - Partie 2-74: Exigences Medizinische elektrische Geräte - Teil 2-74: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des équipements wesentlichen Leistungsmerkmale von
d'humidification respiratoire (ISO 80601-2-74:2017) Anfeuchtersystemen (ISO 80601-2-74:2017)
This European Standard was approved by CEN on 11 November 2019.

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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-74:2020 E
worldwide for CEN national Members.

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EN ISO 80601-2-74:2020 (E)
Contents Page
European foreword . 3

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EN ISO 80601-2-74:2020 (E)
European foreword
The text of ISO 80601-2-74:2017 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 EN ISO 80601-2-74:2020 by 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 2020, and conflicting national standards shall
be withdrawn at the latest by August 2020.
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 8185:2009.
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 80601-2-74:2017 has been approved by CEN as EN ISO 80601-2-74:2020 without any
modification.
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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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INTERNATIONAL ISO
STANDARD 80601-2-74
First edition
2017-05
Medical electrical equipment —
Part 2-74:
Particular requirements for basic
safety and essential performance of
respiratory humidifying equipment
Appareils électromédicaux —
Partie 2-74: Exigences particulières pour la sécurité de base et
les performances essentielles des équipements d’humidification
respiratoire
Reference number
ISO 80601-2-74:2017(E)
©
ISO 2017
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ISO 80601-2-74:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
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ISO 80601-2-74:2017(E)
Contents Page
Foreword . v
Introduction . vii
201.1   Scope, object and related standards . 1
201.2   Normative references . 3
201.3   Terms and definitions . 5
201.4   General requirements . 7
201.5   General requirements for testing of ME EQUIPMENT . 10
201.6   Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7   ME EQUIPMENT identification, marking and documents . 11
201.8   Protection against electrical HAZARDS form ME EQUIPMENT . 19
201.9   Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 19
201.10   Protection against unwanted and excessive radiation HAZARDS . 21
201.11   Protection against excessive temperatures and other HAZARDS . 21
201.12   Accuracy of controls and instruments and protection against
hazardous outputs . 24
201.13   HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 27
201.14   Programmable electrical medical systems (pems) . 28
201.15   Construction of ME EQUIPMENT . 28
201.16   ME SYSTEMS . 29
201.17   Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
201.101   BREATHING SYSTEM connectors and ports . 29
201.102   Requirements for the BREATHING SYSTEM and ACCESSORIES . 32
201.103   LIQUID CONTAINER . 33
201.104   FUNCTIONAL CONNECTION . 34
202   Electromagnetic disturbances — Requirements and tests . 34
206   Usability . 35
208   General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 36
211   Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 36
Annex C (informative)  Guide to marking and labelling requirements for
ME EQUIPMENT and ME SYSTEMS . 38
Annex D (informative)  Symbols on Marking . 44
Annex AA (informative)  Particular guidance and rationale . 45
Annex BB (normative)  * Determination of the accuracy of the displayed MEASURED
GAS TEMPERATURE . 61
Annex CC (normative)  * Determination of the HUMIDIFICATION OUTPUT . 63
Annex DD (normative)  * Specific enthalpy calculations . 67
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ISO 80601-2-74:2017(E)
Annex EE (normative)  Removable temperature sensors and mating ports . 69
Annex FF (normative)  * Standard temperature sensor . 73
Annex GG (informative)  Saturation vapour pressure . 76
Annex HH (informative)  Reference to the essential principles of safety and
[7]
performance of medical devices in accordance with ISO 16142-1:2016 . 77
Annex II (informative)  Terminology — Alphabetized index of defined terms . 81
Bibliography . 85

iv © ISO/IEC 2016 – All rights reserved

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ISO 80601-2-74:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a
subject for which a technical committee has been established has the right to be represented on
that committee. International organizations, governmental and non‐governmental, in liaison
with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance
are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria
needed for the different types of ISO documents should be noted. This document was drafted in
accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
rights. Details of any patent rights identified during the development of the document will be in
the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and
does not constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the World Trade Organization
(WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Lung ventilators and related equipment and IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC 62D, Electromedical equipment.
[1]
This first edition of ISO 80601‐2‐74 cancels and replaces the third edition of ISO 8185:2007 ,
which has been technically revised. It also incorporates the third edition of IEC 60601‐1,
including amendment 1, the fourth edition of IEC 60601‐1‐2, the third edition of IEC 60601‐1‐6,
including amendment 1, the second edition of IEC 60601‐1‐8, including amendment 1, and the
second edition of IEC 60601‐1‐11.
The most significant changes are the following modifications:
— extending the scope to include the HUMIDIFIER and its ACCESSORIES, where the characteristics
of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the HUMIDIFIER,
and thus not only the HUMIDIFIER itself;
— identification of ESSENTIAL PERFORMANCE for a HUMIDIFIER and its ACCESSORIES;
— modification of the humidification test PROCEDURE and the disclosure of humidification
performance;
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ISO 80601-2-74:2017(E)
— more fully dimensioning the removable temperature sensor port and sensor;
— removal of requirements for so‐called “bubble” HUMIDIFIERS as a separate document is being
[8]
prepared for them ;
and the following additions:
— requirements for mechanical strength (via IEC 60601‐1‐11);
— new symbols;
— requirements for a HUMIDIFIER as a component of an ME SYSTEM;
— requirements for ENCLOSURE integrity (water ingress via IEC 60601‐1‐11);
— requirements for cleaning and disinfection PROCEDURES (via IEC 60601‐1‐11);
— requirements for BIOCOMPATIBILITY;
— requirements for USABILITY.
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ISO 80601-2-74:2017(E)
Introduction
This document specifies requirements for respiratory humidifying equipment intended for use
on PATIENTS in HOME HEALTHCARE ENVIRONMENT and in healthcare facilities. HUMIDIFIERS are used to
raise the water content of gases delivered to PATIENTS. Gases available for medical use do not
contain sufficient moisture and can damage or irritate the respiratory tract or desiccate
secretions of PATIENTS whose upper airways have been bypassed. Inadequate humidity at the
PATIENT‐CONNECTION PORT can cause drying of the upper airway, or desiccation of tracheo‐
bronchial secretions in the tracheal or tracheostomy tube, which can cause narrowing or even
[19][20]
obstruction of the airway . Heat is employed to increase the water output of the HUMIDIFIER.
In addition, many HUMIDIFIERS utilize heated BREATHING TUBES in order to increase operating
efficiency and reduce water loss (condensate) as well as heat loss in the BREATHING TUBE.
Ventilator and anaesthesia BREATHING TUBES in common use might not withstand the heat
generated by HUMIDIFIERS and BREATHING TUBE heating mechanisms.
Many HUMIDIFIER MANUFACTURERS use off‐the‐shelf electrical connectors for their electrically
heated BREATHING TUBES. However, since different MANUFACTURERS have used the same electrical
connector for different power outputs, electrically heated BREATHING TUBES can be physically, but
not electrically, interchangeable. Use of improper electrically heated BREATHING TUBES has caused
overheating, circuit melting, PATIENT and OPERATOR burns and fires. It was not found practical to
specify the interface requirements for electrical connectors to ensure compatibility between
HUMIDIFIERS and BREATHING TUBES produced by different MANUFACTURERS.
Since the safe use of a HUMIDIFIER depends on the interaction of the HUMIDIFIER with its many
ACCESSORIES, this document sets total system performance requirements up to the PATIENT‐
CONNECTION PORT. These requirements are applicable to ACCESSORIES such as BREATHING TUBES
(both heated and non‐heated), temperature sensors and equipment intended to control the
environment within these BREATHING TUBES.
Humidification can also be used by respiratory support ME EQUIPMENT to increase PATIENT
comfort and compliance with the therapy. Examples are obstructive sleep apnoea and nasal high
flow therapy equipment. The HUMIDIFICATION OUTPUT requirements of such ME EQUIPMENT is less
demanding as the PATIENT’S upper airway is not bypassed.
HUMIDIFIERS are commonly used with air and air‐oxygen mixtures and any HUMIDIFIER should be
able to operate with these gases. Care should be taken if using other gas mixes such as helium‐
oxygen mixtures, as the different physical and thermal properties of these gases may disturb the
operation of the HUMIDIFIER.
In this document, the following print types are used:
— Requirements and definitions: roman type;
— Test specifications: italic type;
— Informative material appearing outside of tables, such as notes, examples and references: in
smaller type. Normative text of tables is also in a smaller type;
— Terms defined in CLAUSE 3 of the general standard, in this document or as noted: small
capitals;
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ISO 80601-2-74:2017(E)
In referring to the structure of this document, the term
— “clause” means one of the five numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
— “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of
a new, amended or revised ISO or IEC publication in which to make products in accordance with
the new requirements and to equip themselves for conducting new or revised tests. It is the
recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication for equipment
newly designed and not earlier than 5 years from the date of publication for equipment already
in production.
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INTERNATIONAL STANDARD ISO 80601-2-74:2017(E)

Medical electrical equipment —
Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment
201.1   Scope, object and related standards
IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows.
201.1.1   * Scope
Replacement:
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a HUMIDIFIER, also
hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES, the combination also
hereafter referred to as ME SYSTEM.
This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to a HUMIDIFIER where the characteristics of those ACCESSORIES can affect the BASIC
SAFETY or ESSENTIAL PERFORMANCE of the HUMIDIFIER.
EXAMPLE 1 Heated BREATHING TUBES (heated‐wire BREATHING TUBES) or ME EQUIPMENT intended to
control these heated BREATHING TUBES (heated BREATHING TUBE controllers).
NOTE 1 Heated BREATHING TUBES and their controllers are ME EQUIPMENT and are subject to the
requirements of IEC 60601‐1.
NOTE 2 ISO 5367 specifies other safety and performance requirements for BREATHING TUBES.
This document includes requirements for the different medical uses of humidification, such as
invasive ventilation, non‐invasive ventilation, nasal high‐flow therapy, and obstructive sleep
apnoea therapy, as well as humidification therapy for tracheostomy PATIENTS.
NOTE 3 A HUMIDIFIER can be integrated into other equipment. When this is the case, the requirements of
the other equipment also apply to the HUMIDIFIER.
[12]
EXAMPLE 2 Heated HUMIDIFIER incorporated into a critical care ventilator where ISO 80601‐2‐12
also applies.
EXAMPLE 3 Heated HUMIDIFIER incorporated into a homecare ventilator for dependent PATIENTS where
[14]
ISO 80601‐2‐72 also applies.
EXAMPLE 4 Heated HUMIDIFIER incorporated into sleep apnoea therapy equipment where ISO 80601‐2‐
[13]
70 also applies.
This document also includes requirements for an ACTIVE HME (HEAT AND MOISTURE EXCHANGER),
ME EQUIPMENT which actively adds heat and moisture to increase the humidity level of the gas
delivered from the HME to the PATIENT. This document is not applicable to a passive HME, which
returns a portion of the expired moisture and heat of the PATIENT to the respiratory tract during
inspiration without adding heat or moisture.
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ISO 80601-2-74:2017(E)
[5] [6]
NOTE 4 ISO 9360‐1 and ISO 9360‐2 specify the safety and performance requirements for a passive
HME.
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, 7.2.13 and 8.4.1.
NOTE 5 Additional information can be found in IEC 60601‐1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for cold pass‐over or cold bubble‐through
[8]
humidification devices, the requirements for which are given in ISO 20789:—.
This document is not applicable to equipment commonly referred to as “room humidifiers” or
humidifiers used in heating, ventilation and air conditioning systems, or HUMIDIFIERS
incorporated into infant incubators.
This document is not applicable to nebulizers used for the delivery of drugs to PATIENTS.
[10]
NOTE 6 ISO 27427 specifies the safety and performance requirements for nebulizers.
This document is a particular standard in the IEC 60601‐1 and the ISO/IEC 80601 series.
201.1.2   Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a HUMIDIFIER, as defined in 201.3.209, and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the HUMIDIFIER and the ACCESSORIES needs
to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL
PERFORMANCE of a HUMIDIFIER.
201.1.3   Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and Clause 201.2 of this document.
IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8 and IEC 60601‐1‐11 apply as modified in
[15]
Clauses 202, 206, 208 and 211, respectively. IEC 60601‐1‐3 does not apply. All other
published collateral standards in the IEC 60601‐1 series apply as published.
201.1.4   Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular

The general standard is IEC 60601‐1:2005+AMD1:2012.
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ISO 80601-2-74:2017(E)
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601‐1 is referred to in this document as the general standard. Collateral
standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
the general standard) or applicable collateral standard with the prefix “20x”, where x is the final
digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the
content of Clause 4 of the IEC 60601‐1‐2 collateral standard, 208.6 in this document addresses
the content of Clause 6 of the IEC 60601‐1‐8 collateral standard, etc.). The changes to the text of
the general standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of the general
standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of the general standard are numbered
starting from 201.101. However, due to the fact that definitions in the general standard are
numbered 3.1 through 3.139, additional definitions in this document are numbered beginning
from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2,
203 for IEC 6060‐1‐3, etc.
The term “this document” is used to make reference to the general standard, any applicable
collateral standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of the general standard or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of the general standard or applicable
collateral standard, although possibly relevant, is not to be applied, a statement to that effect is
given in this document.
201.2   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.
IEC 60601‐1:2005+AMD1:2012, Clause 2 applies, except as follows.
Replacement:
IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic
safety and essential performance — Collateral Standard: Electromagnetic disturbances —
Requirements and tests
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IEC 60601‐1‐6:2010+AMD1:2013, Medical electrical equipment — Part 1-6: General requirements
for basic safety and essential performance — Collateral Standard: Usability
IEC 60601‐1‐8:2006+AMD1:2012, Medical electrical equipment — Part 1-8: General requirements
for basic safety and essential performance — Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise
sources using sound pressure — Engineering methods for an essentially free field over a reflecting
plane
ISO 5356‐1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones
and sockets
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396‐1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical
gases and vacuum
ISO 14937:2009, Sterilization of health care products — General requirements for
characterization of a sterilizing agent and the development, validation and routine control of a
sterilization process for medical devices
ISO 15223‐1:2016, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the
manufacturer for the processing of resterilizable medical devices
ISO 18562‐1:—, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 1: Evaluation and testing within a risk management process
ISO 80369‐1:2010, Small-bore connectors for liquids and gases in healthcare applications —
Part 1: General requirements
IEC 60601‐1:2005+AMD1:2012, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
IEC 60601‐1‐11:2015, Medical electrical equipment — Part 1-11: General requirements for basic
safety and essential performance — Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 60601‐2‐19:2009, Medical electrical equipment — Part 2-19: Particular requirements for the
basic safety and essential performance of infant incubators

To be published.
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IEC 61672‐1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62304:2006+AMD1:2015, Medical device software — Software life cycle processes
EN 15986:2011, Symbol for use in the labelling of medical devices — Requirements for labelling of
medical devices containing phthalates
201.3   Terms and definitions
[1]
For the purposes of this document, the terms and definitions given in ISO 4135:2001 ,
[5] [9]
ISO 7396‐1:2016, ISO 9360‐1:2000 , ISO 23328‐2:2002 , IEC 60601‐1:2005+AMD1:2012,
IEC 60601‐1‐2:2014, IEC 60601‐1‐8:2006+AMD1:2012, IEC 60601‐1‐11:2015,
[18]
IEC 62366‐1:2015 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An alphabetized index of defined terms is found beginning in Annex DD.
IEC 60601‐1:2005+AMD1:2012, Clause 3 applies, except as follows:
Additions:
201.3.201
ACTIVE HME
ACTIVE HEAT AND MOISTURE EXCHANGER
HUMIDIFIER where water, water vapour or heat is actively added to the HEAT AND MOISTURE EXCHANGER
(HME) to increase the humidity level of the gas flowing from the HME to the PATIENT
201.3.202
AIRWAY PRESSURE
P
aw
pressure at the patient‐connection port
201.3.203
BODY TEMPERATURE PRESSURE, SATURATED
BTPS
ambient atmospheric pressure and a RELATIVE HUMIDITY of 100 % at a temperature of 37 °C
Note 1 to entry: Respiratory physiology lung volumes and flows are standardized to BTPS.
201.3.204
DELIVERED GAS TEMPERATURE
temperature of the gas, or aerosol, or both, at the PATIENT‐CONNECTION PORT
201.3.205
FLOW-DIRECTION-SENSITIVE COMPONENT
component or ACCESSORY through which gas flow has to be in one direction only for proper functioning
or PATIENT safety
[1]
[SOURCE: ISO 4135:2001, 3.1.7 , modified —added “or ACCESSORY”and replaced “must” with “has to”.]
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201.3.206
HEATED BREATHING TUBE CONTROLLER
ME EQUIPMENT which controls the temperature or the heating of a BREATHING TUBE
Note 1 to entry: A HEATED BREATHING TUBE CONTROLLER can be either stand‐alone or part of the HUMIDIFIER.
201.3.207
HUMIDIFICATION CHAMBER
part of the HUMIDIFIER in which vaporization or nebulization takes place
201.3.208
HUMIDIFICATION OUTPUT
total mass of water vapour per unit volume of gas at the PATIENT‐CONNECTION PORT under BTPS conditions
201.3.209
HUMIDIFIER
ME EQUIPMENT that adds water in the form of droplets or vapour, or both, to the inspired gas
EXAMPLE Vaporizing and ultrasonic equipment and an ACTIVE HME are types of HUMIDIFIERS.
201.3.210
LIQUID CONTAINER
part of the HUMIDIFIER which holds the liquid
Note 1 to entry: The LIQUID CONTAINER can be accessible to the breathing gas.
Note 2 to entry: The LIQUID CONTAINER can also be part of the HUMIDIFICATION CHAMBER.
Note 3 to entry: The LIQUID CONTAINER can be detachable for filling.
201.3.211
LIQUID RESERVOIR
part of the HUMIDIFIER which replenishes the LIQUID CONTAINER
201.3.212
MAXIMUM LIMITED PRESSURE
P
LIM max
highest AIRWAY PRESSURE during NORMAL USE or under SINGLE FAULT CONDITION
201.3.213
MAXIMUM OPERATING PRESSURE
maximum pressure in the HUMIDIFICATION CHAMBER during NORMAL USE
201.3.214
MEASURED GAS TEMPERATURE
temperature of the gas, or aerosol, or both, that the ME SYSTEM is measuring and, if applicable, displaying
201.3.215
MONITORING EQUIPMENT
ME EQUIPMENT or part that continuously or continually measures and indicates the value of a variable to
the OPERATOR
[12]
[SOURCE: ISO 80601‐2‐12:2011, 201.3.217 ]

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201.3.216
PATIENT-CONNECTION PORT
port at the PATIENT‐end of the BREATHING TUBES intended for connection to an airway device
EXAMPLE A tracheal tube, tracheostomy tube, face mask and supralaryngeal airway are all airway
devices.
201.3.217
PROTECTION DEVICE
part or function of ME EQUIPMENT that, without intervention by the OPERATOR, protects the PATIENT from
hazardous output due to incorrect delivery of energy or substances
[12]
[SOURCE: ISO 60601‐2‐12:2011, 201.3.220 ]
201.3.218
RELATIVE HUMIDITY
water vapour pressure, expressed as a percentage of the saturation vapour pressure, at a particular
temperature
201.3.219
SET TEMPERATURE
temperature at which the HUMIDIFIER attempts to maintain MEASURED GAS TEMPERATURE
Note 1 to entry: The SET TEMPERATURE may be OPERATOR‐adjustable.
201.3.220
STANDARD TEMPERATURE AND PRESSURE, DRY
STPD
pressure of 101,325 kPa at an operating temperature of 20 °C
201.3.221
VALIDATION
confirmation, through the provision of OBJECTIVE EVIDENCE, that the requirements for a specific INTENDED
USE or application have been fulfilled
Note 1 to entry: The OBJECTIVE EVIDENCE needed for a VALIDATION is the result of a test or other form of
determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The term “VALIDATED” is used to designate the corresponding status.
Note 3 to entry: The use conditions for VALIDATION can be real or simulated.
[4]
[SOURCE: ISO 9000:2015, 3.8.13 ]
201.4   General requirements
IEC 60601‐1:2005+AMD1:2012, Clause 4 applies, except as follows.
201.4.3   ESSENTIAL PERFORMANCE
IEC 60601‐1:2005+AMD1:2012, 4.3 applies, except as follows.
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Additional subclause:
201.4.3.101   * Additional requirements for ESSENTIAL PERFORMANCE
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
a
For category 1 HUMIDIFIERS, delivery of HUMIDIFICATION OUTPUT 201.12.1.101

or generation of a TECHNICAL ALARM CONDITION
a
For HUMIDIFIERS equipped with SET TEMPERATURE MONITORING 201.12.1.101
EQUIPMENT, delivery of HUMIDIFICATION OUTPUT

or generation of a TECHNICAL or PHYSIOLOGICAL ALARM CONDITION
For all other category 2 HUMIDIFIERS for the purposes of this —
document, category 2 HUMIDIFIERS are considered to not have
ESSEN
...