201.1 Scope, object and related standards

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 1 applies, except as follows:

201.1.1 Scope

Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:

— intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
— intended to be operated by a healthcare professional operator;
— intended for use in the EMS environment; and
— intended for invasive or non-invasive ventilation.

NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.

An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.

NOTE 3 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.

This document does not specify the requirements for the following:

NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.

— ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601‑2‑12.
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72.
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
— ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2‑79 and ISO 80601‑2‑80.
— obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70.
— user-powered resuscitators, which are given in ISO 10651‑4.
— gas-powered emergency resuscitators, which are given in ISO 10651‑5.
— continuous positive airway pressure (CPAP) ME equipment.
— high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87.
— high-frequency oscillatory ventilators (HFOVs)^[44], which are given in ISO 80601‑2‑87.

NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
— respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90.

NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
— oxygen therapy constant flow ME equipment.
— cuirass or “iron-lung” ventilators.

201.1.2 Object

Replacement:

The object of this particular document is to establish basic safety and essential performance requirements for an EMS ventilator, as defined in 201.3.228, and its accessories.

Accessories are included because the combination of the EMS ventilator and the accessories needs to have acceptable risk. Accessories can have a significant impact on the basic safety or essential performance of an EMS ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles^[38] and labelling^[39] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142‑1:2016 as indicated in Annex DD.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745^[40].

201.1.3 Collateral standards

Amendment (add at the end of the subclause):

This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and in 201.2 of this document.

NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.

IEC 60601‑1‑2:2014+AMD1:2020 , IEC 60601‑1‑6:2010+AMD1:2013+AMD2:2020, IEC 60601‑1‑8:2016+AMD1:2012+AMD2:2020 and IEC 60601‑1‑12:2014+AMD1:2020 apply as modified in Clauses 202, 206, 208 and 212 respectively.

IEC 60601‑1‑3 , IEC 60601‑1‑9, and IEC 60601‑1‑11 do 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, including the collateral standards, as appropriate for the particular ME equipment under consideration, and may add other basic safety or essential performance requirements.

A requirement of a particular standard takes priority over IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the collateral standards.

For brevity, IEC 60601‑1:2005+AMD1:2012+AMD2:2020 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 particular document corresponds to those 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 “2xx” where xx is the final digits 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, 208.4 in this document addresses the content of Clause 4 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 IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard is replaced completely by the text of this particular document.

“Addition” means that the text of this document is additional to the requirements of IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables that 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 3.154, 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 or figures that 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, 208 for IEC 60601‑1‑8, 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 IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005+AMD1:2012+AMD2:2020 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular 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.

ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
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 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 5356‑1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5359:2014+AMD1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396‑1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 9360‑1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360‑2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
ISO 10524‑1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 10524‑3:2019, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRS)
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 17664‑1:2021, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664‑2:2021, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562‑1:2023, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 19054:2005+AMD1:2016, Rail systems for supporting medical equipment
ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 23328‑1:2003, Breathing system filters for anaesthetic and respiratory use: — Part 1: Salt test method to assess filtration performance
ISO 23328‑2:2002, Breathing system filters for anaesthetic and respiratory use: — Part 2: Non-filtration aspects
ISO 80601‑2‑55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601‑2‑74:2021, Medical electrical equipment — Part 2-74: Particular requirements for the basic safety and essential performance of respiratory humidifying equipment
IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601‑1‑12:2014+AMD1:2020, Medical Electrical Equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment
IEC 61672‑1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366‑1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
IEC Guide 115:2021, Application of uncertainty of measurement to conformance assessment activities in the electrotechnical sector

201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, and the following apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/

201.3.201

accompanying information

information accompanying or marked on a medical device or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use

Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.

Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc.

Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).

[SOURCE: ISO 20417:2021 , 3.2, modified — deleted note 4.]

201.3.202

acknowledged

state of an alarm system initiated by operator action, where the auditory alarm signal associated with a currently active alarm condition is inactivated until the alarm condition no longer exists or until a predetermined time interval has elapsed

Note 1 to entry: Acknowledged only affects alarm signals that are active at the time of the operator action.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.37]

201.3.203

airway pressure

P _aw

pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-connection port

Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the equipment.

[SOURCE: ISO 4135:2022 , 3.1.4.41.1]

201.3.204

alarm condition delay

time from the occurrence of a triggering event either in the patient, for physiological alarm conditions, or in the equipment, for technical alarm conditions, to when the alarm system determines that an alarm condition exists

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.2]

201.3.205

alarm limit

threshold used by an alarm system to determine an alarm condition

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.3]

201.3.206

alarm off

state of indefinite duration in which an alarm system or part of an alarm system does not generate alarm signals

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.4]

201.3.207

alarm paused

state of limited duration in which the alarm system or part of the alarm system does not generate alarm signals

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.5]

201.3.208

alarm settings

alarm system configuration, including but not limited to:

— alarm limits;
— the characteristics of any alarm signal inactivation states; and
— the values of variables or parameters that determine the function of the alarm system

Note 1 to entry: Some algorithmically-determined alarm settings can require time to be determined or re-determined.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.8]

201.3.209

artificial ventilation

intermittent elevation of the pressure in the patient's airway relative to that in the lungs by external means with the intention of augmenting, or totally controlling, the ventilation of a patient

EXAMPLE:

Means used to provide artificial ventilation are: manual resuscitation; mouth-to-mouth resuscitation; automatic ventilation; mechanical ventilation.

Note 1 to entry: Common classifications of areas of application of artificial ventilation are: emergency; transport; home-care; anaesthesia; critical care; rehabilitation.

Note 2 to entry: Classifications used to denote means used for artificial ventilation include: positive-pressure; negative-pressure; gas-powered; operator-powered; electrically-powered.

Note 3 to entry: Negative-pressure ventilation elevates the relative pressure in the airway by intermittently lowering the pressure in the lungs.

[SOURCE: ISO 19223:2019 , 3.1.10]

201.3.210

assured inflation-type rate

number of assured inflation-type initiations in a specified period of time, expressed as breaths per minute

[SOURCE: ISO 19223:2019 , 3.5.2.1, modified — deleted notes.]

201.3.211

attack

attempt to destroy, expose, alter, disable, steal or gain unauthorized access to or make unauthorized use of an asset

[SOURCE: IEC 81001‑5‑1:2021 , 3.5]

201.3.212

audio off

state of indefinite duration in which the alarm system or part of the alarm system does not generate an auditory alarm signal

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.12]

201.3.213

audio paused

state of limited duration in which the alarm system or part of the alarm system does not generate an auditory alarm signal

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.13]

201.3.214

BAP

quantity by which the baseline airway pressure is set to be positively offset from the ambient pressure

[SOURCE: ISO 19223:2019 , 3.10.2, modified — deleted notes.]

201.3.215

biocompatibility

ability to be in contact with a living system without producing an unacceptable adverse effect

Note 1 to entry: A medical device or accessory may produce some level of adverse effect, but that level may be determined to be acceptable when considering the benefits provided by the medical device or accessory.

[SOURCE: ISO 18562‑1:2023 , 3.6]

201.3.216

body temperature and pressure saturated

BTPS

ambient atmospheric pressure, at a temperature of 37 °C, and a relative humidity of 100 %

[SOURCE: ISO 4135:2022 , 3.1.1.7]

201.3.217

breathing system

pathways through which gas flows to or from the patient at respiratory pressures and continuously or intermittently in fluid communication with the patient’s respiratory tract during any form of artificial ventilation or respiratory therapy

[SOURCE: ISO 4135:2022 , 3.6.1.1, modified — deleted notes.]

201.3.218

breathing system filter

BSF

device intended to reduce transmission of particulates, including microorganisms, in breathing systems

[SOURCE: ISO 23328‑2:2002 , 3.2]

201.3.219

cleaning

removal of contaminants to the extent necessary for further processing or for intended use

Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of a medical device by a manual or automated process that prepares the items for safe handling or further processing.

[SOURCE: ISO 17664‑2:2021 , 3.1, modified — replaced 'and/or' with 'or'.]

201.3.220

communicator

COM

function of the alarm system that generates alarm signals to notify an operator (e.g. to the presence of an alarm condition)

Note 1 to entry: A communicator can receive an operator response.

Note 2 to entry: An operator response is not limited to direct operator action.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.46, modified — deleted note 3.]

201.3.221

connector

fitting to join two or more components

EXAMPLE:

Connectors for a low-pressure hose assembly are any of a range of mating components intended to maintain gas specificity by the allocation of a set of different diameters to the mating connectors for each particular gas.

[SOURCE: ISO 4135:2022 , 3.1.4.5]

201.3.222

CPAP

continuous positive airway pressure

ventilation-mode or sleep-apnoea breathing-therapy mode in which the patient breathes continuously at a set airway-pressure level, above ambient pressure

[SOURCE: ISO 19223:2019 , 3.11.15, modified — deleted notes.]

201.3.223

cybersecurity

state where information and systems are protected from unauthorized activities, such as access, use, disclosure, disruption, modification, or destruction to a degree that the related risks to violation of confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle

[SOURCE: IEC 81001‑5‑1:2021 , 3.30]

201.3.224

Δ inspiratory pressure

differential airway pressure relative to baseline airway pressure during an inflation phase

Note 1 to entry: In addition to its direct reference, this term or an appropriate symbol may be used, in context or by qualification, to designate this concept as a set quantity or a measured quantity.

Note 2 to entry: There is currently no agreed convention as to whether an inspiratory pressure is always to be expressed as an absolute quantity relative to ambient pressure or an absolute quantity for one group of inflation-types and relative for another. This has unacceptable patient-safety implications that need to be addressed in a vocabulary of lung ventilation. The symbol, Δ, is currently sometimes used as a prefix to make this distinction, and that convention has been adopted as a requirement in this document. Without a prefix, or any other indication, respiratory pressures are always to be considered to be relative to ambient pressure. The addition of a Δ prefix, is used to indicates a pressure that is relative to the set BAP level. In ventilation-modes where there is a second, higher, baseline airway pressure, then the prefix for a pressure relative to that higher-pressure level becomes ΔH. These prefixes are applicable to relevant terms, symbols and displayed values but not to inflation-types.

Note 3 to entry: The sum of the set BAP level and the Δ inspiratory pressure equals the inspiratory pressure. This applies to both settings and measurements of this parameter.

[SOURCE: ISO 19223:2019 , 3.6.7, modified — deleted note 4.]

201.3.225

disinfection

process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose

[SOURCE: ISO 17664‑2:2021 , 3.5]

201.3.226

distributed alarm system

DAS

alarm system that involves more than one item of equipment of a ME system intended for delivery of alarm conditions with technical confirmation

Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.

Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm condition.

Note 3 to entry: For the purposes of this document, technical confirmation means that each element of a distributed alarm system confirms or guarantees the successful delivery of the alarm condition to the next element or appropriate technical alarm conditions are created as described in IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020, 6.11.2.2.1.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.17]

201.3.227

EMS environment

emergency medical services environment

actual conditions and settings, in which operators interact with the ME equipment or ME system, in and around the scene of an emergency outside of a professional healthcare facility where a patient can be given medical care, basic or advanced life support as well as during professional transport to a professional healthcare facility or between professional healthcare facilities

EXAMPLE 1:

Responding to and providing life support at the scene of an emergency to a patient reported as experiencing injury or illness in a pre-hospital setting, and transporting the patient, while continuing such life support care, to an appropriate professional healthcare facility for further care.

EXAMPLE 2:

Providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.

Note 1 to entry: For the purposes of this standard, use of equipment intended for the EMS environment and temporarily used in the home healthcare environment by emergency medical personnel is considered use in the EMS environment.

Note 2 to entry: For the purposes of this standard, the operators of equipment intended for the EMS environment are presumed to be professional medical personnel or personnel with relevant specialized training.

Note 3 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms and multiple treatment facilities.

Note 4 to entry: Emergency medical services are known by various names in different countries and regions.

Note 5 to entry: For the purposes of this standard, transport includes road, rotary and fixed-wing ambulances.

[SOURCE: IEC 60601‑1‑12:2014+AMD1:2020 , 3.1]

201.3.228

EMS ventilator

ventilator for emergency medical services environment
ventilator intended for use in the EMS environment

201.3.229

end-expiratory flow

expiratory flow at the point of initiation of an inflation or an inspiration

[SOURCE: ISO 19223:2019 , 3.7.6, modified — deleted notes.]

201.3.230

essential function

function or capability that is required to maintain basic safety, essential performance, a minimum of clinical functionality as specified by the manufacturer, and operational availability for the medical device

Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety and essential performance), the control function and the availability of urgently needed functions and such allowing the operator to view and manipulate the medical device safely with the most urgently needed performance (operational availability). The loss of essential function is commonly termed loss of protection, loss of control and loss of view respectively.

Note 2 to entry: The term is derived from IEC 62443‑4‑2:2019, 3.1.20, and has been refined for the purpose and scope of this document.

[SOURCE: IEC/TR 60601‑4‑5:2021 , 3.10]

201.3.231

essential principles

essential principles of safety and performance

fundamental high-level requirements that when complied with ensure a medical device is safe and performs as intended

[SOURCE: ISO 16142‑1:2016 , 3.3]

201.3.232

exhaust port

port of the medical equipment or device from which gas is discharged to the atmosphere during normal use, either directly or via an anaesthetic gas scavenging system

[SOURCE: ISO 19223:2019 , 3.14.2]

201.3.233

expiratory pause

portion of the expiratory phase from the end of expiratory flow to the start of inspiratory flow

[SOURCE: ISO 19223:2019 , 3.4.4, modified — deleted notes.]

201.3.234

expiratory phase

interval from the start of expiratory flow to the start of inspiratory flow within a respiratory cycle

[SOURCE: ISO 19223:2019 , 3.4.2, modified — deleted notes.]

201.3.235

false positive alarm condition

presence of an alarm condition when no valid triggering event has occurred in the patient, the equipment or the alarm system

Note 1 to entry: A false positive alarm condition can be caused by spurious information produced by the patient, the patient-equipment interface, other equipment or the alarm system itself.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.21]

201.3.236

firecall

method established to provide emergency access to a secure medical device

Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the problem. When a firecall is used, there is usually a review process to ensure that the access was used properly to correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time password or other suitable measures.

Note 2 to entry: Also referred to as "break glass" feature.

[SOURCE: IEC/TR 60601‑4‑5:2021 , 3.11]

201.3.237

flow-direction-sensitive component

component or accessory through which gas flow has to be in one direction only for proper functioning or patient safety

[SOURCE: ISO 4135:2022 , 3.1.4.15]

201.3.238

fresh gas

respirable gas delivered to a ventilator breathing system

[SOURCE: ISO 4135:2022 , 3.1.1.16, modified — Added ‘ventilator’ and deleted notes.]

201.3.239

gas intake port

port through which gas is drawn for use by the patient

Note 1 to entry: Gas is drawn at a sub-ambient pressure at a gas intake port, in apposition to an inlet, at which gas is provided by a medical gas supply system.

[SOURCE: ISO 4135:2022 , 3.1.4.21]

201.3.240

gas output port

port of the ventilator through which gas is delivered at respiratory pressures to an operator-detachable part of the ventilator breathing system

[SOURCE: ISO 19223:2019 , 3.14.3]

201.3.241

gas pathway

interior surfaces, over which gases or liquids that can be inspired, in a medical device bounded by the ports through which gases or liquids enter and leave the medical device including the patient interface or the interior surfaces of enclosures that are in contact with gases or liquids that can be inspired

Note 1 to entry: Patient contact surfaces such as the outer surfaces of a tracheal tube or the cushion of a mask are evaluated according to the ISO 10993 series.

EXAMPLE 1:

The ventilator breathing system, inlet filter, gas mixer, blower and internal piping.

EXAMPLE 2:

Enclosed chamber of an incubator including the mattress or the inner surface of an oxygen hood.

EXAMPLE 3:

The inner surfaces of breathing tubes, tracheal tubes or masks and mouthpieces.

[SOURCE: ISO 18562‑1:2023 , 3.11]

201.3.242

gas return port

port of the ventilator through which gas is returned at respiratory pressures through an operator-detachable part of the ventilator breathing system, from the patient-connection port

[SOURCE: ISO 19223:2019 , 3.14.4]

201.3.243

healthcare professional

<adj> appropriately trained, knowledgeable, and skilled, providing systematic preventive, curative, promotional or rehabilitative healthcare services

[SOURCE: ISO 80601‑2‑12:2023 , 201.3.247]

201.3.244

heat and moisture exchanger

HME

device intended to retain a portion of the patient's expired moisture and heat, and return it to the respiratory tract during inspiration

[SOURCE: ISO 9360‑1:2000 , 3.1]

201.3.245

high-pressure inlet

inlet to which gas is supplied at a pressure exceeding 100 kPa above ambient

Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 600 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

[SOURCE: ISO 4135:2022 , 3.1.4.24]

201.3.246

home healthcare environment

dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present

EXAMPLE:

In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.

Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms, multiple treatment facilities and emergency medical services.

Note 2 to entry: For the purpose of this collateral standard, nursing homes are considered home healthcare environments.

Note 3 to entry: Other places where a patient is present include the outdoor environment, while working and in vehicles.

[SOURCE: IEC 60601‑1‑11:2015+AMD1:2020 , 3.1]

201.3.247

humidifier

device that adds water in the form of droplets or vapour, or both, to the inspired gas

Note 1 to entry: This term includes vaporising, bubble-through and ultrasonic humidifiers and active heat and moisture exchangers.

[SOURCE: ISO 4135:2022 , 3.7.2.1]

201.3.248

I:E ratio

ratio of the inspiratory time to the expiratory time in a respiratory cycle

[SOURCE: ISO 19223:2019 , 3.4.19, modified — deleted notes.]

201.3.249

immunity

ability of ME equipment or an ME system to perform without degradation in the presence of an electromagnetic disturbance

[SOURCE: IEC 60601‑1‑2:2014+AMD1:2020 , 3.8]

201.3.250

inflation

ventilator action intended to increase the volume of gas in the lungs by the application of an elevated-pressure waveform to the patient-connection port until a specified termination criterion is met

[SOURCE: ISO 19223:2019 , 3.3.1, modified — deleted notes.]

201.3.251

inflation phase

interval from the start of the rise in airway pressure resulting from the initiation of an inflation to the start of the expiratory flow resulting from its termination

[SOURCE: ISO 19223:2019 , 3.4.10, modified — deleted notes.]

201.3.252

inflation-type

inflation characterized by its temporal delivery pattern following initiation, and its termination criteria

[SOURCE: ISO 19223:2019 , 3.3.2, modified — deleted notes.]

201.3.253

information supplied by the manufacturer

information related to the identification and use of a medical device or accessory, in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory

Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the manufacturer.

Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental information as information supplied by the manufacturer.

Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons.

[SOURCE: ISO 20417:2021 , 3.10, modified — deleted note 4.]

201.3.254

inlet

opening through which gas or other material is pushed by an elevated upstream pressure

[SOURCE: ISO 4135:2022 , 3.1.4.26, modified — deleted note.]

201.3.255

inspiratory pause

interval from the end of inspiratory flow to the start of expiratory flow within a respiratory cycle

[SOURCE: ISO 19223:2019 , 3.4.12, modified — deleted notes.]

201.3.256

inspiratory time

t _I

duration of an inflation phase or inspiratory phase

[SOURCE: ISO 19223:2019 , 3.4.8, modified — deleted notes.]

201.3.257

inspiratory volume

V _insp

volume of gas delivered through the patient-connection port during an inspiratory phase or inflation phase

[SOURCE: ISO 19223:2019 , 3.8.3, modified — deleted notes.]

201.3.258

instructions for use

IFU

portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device

Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training.

Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use.

Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item.

Note 4 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or accessory.

Note 5 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities having jurisdiction.

[SOURCE: ISO 20417:2021 , 3.11, modified — deleted note 6.]

201.3.259

intelligent alarm system

alarm system that makes logical decisions based on monitored information without operator intervention

EXAMPLE 1:

An alarm system that changes priority based on the rate of change of a monitored variable.

EXAMPLE 2:

An alarm system that suppresses an alarm condition when a related alarm condition of higher priority has recently generated an alarm signal.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.24]

201.3.260

latching alarm signal

alarm signal that continues to be generated after its triggering event no longer exists until stopped by deliberate operator action

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.26]

201.3.261

low-pressure hose assembly

assembly consisting of a flexible hose with permanently attached gas-specific inlet and outlet connectors and designed to conduct a medical gas at pressures less than 1 400 kPa

Note 1 to entry: The phrases ‘low-pressure’ and ‘high-pressure’ are used differently in various contexts, including breathing system pressures (typically less than 10 kPa), terminal outlet pressures (less than 1 400 kPa), manifold pressures (typically up to 3 000 kPa) and cylinder pressures (typically less than 30 000 kPa).

[SOURCE: ISO 4135:2022 , 3.2.3.1]

201.3.262

lung

each of the pair of compliant organs within the ribcage (thorax), bounded by the terminal bronchiole and the visceral pleura, which during ventilation provide gas/blood interfaces that enable oxygen from the gas to pass into the blood and carbon dioxide to be removed

[SOURCE: ISO 19223:2019 , 3.1.16, modified — deleted notes.]

201.3.263

marking

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory

Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.

Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking.

[SOURCE: ISO 20417:2021 , 3.16, modified — deleted note 3.]

201.3.264

mask

device which provides a non-invasive interface between the patient’s airway and a patient-connection port or other connection to a source of respirable gas

[SOURCE: ISO 4135:2022 , 3.8.6.4]

201.3.265

maximum limited pressure

P _LIM,max

highest airway pressure that can occur during normal use or under single fault condition

[SOURCE: ISO 4135:2022 , 3.1.4.41.3]

201.3.266

maximum working pressure

P _{W
max}

highest airway pressure that can be generated by the ventilator during intended use and normal condition

[SOURCE: ISO 19223:2019 , 3.13.4, modified — deleted notes.]

201.3.267

medical gas pipeline system

combination of a supply system, a monitoring and alarm system and a pipeline distribution system with terminal units for provision of medical gases or vacuum

[SOURCE: ISO 4135:2022 , 3.2.1.1]

201.3.268

monitoring equipment

equipment or part that measures and indicates the value of a variable to the operator

Note 1 to entry: Monitoring equipment includes devices that are not electrical in operation, such as a pressure gauge.

Note 2 to entry: The value can be displayed continually or intermittently.

Note 3 to entry: The monitoring equipment can be primarily intended for detection of an alarm condition or for external communication.

[SOURCE: ISO 4135:2022 , 3.11.1.3, modified —replaced "user" with "operator".]

201.3.269

operator group

subset of operators who are differentiated from other operators by factors that are likely to influence their interactions with the ME equipment

Note 1 to entry: Attributes of operator groups can include age, culture, expertise.

[SOURCE: IEC 60601‑1‑6:2010+AMD1:2013+AMD2:2020 , 3.3]

201.3.270

operator interface

means by which the operator and the ME equipment interact

Note 1 to entry: The accompanying documents are considered part of the ME equipment and its operator interface.

Note 2 to entry: Operator interface includes all the elements of the ME equipment with which the operator interacts including the physical aspects of the ME equipment as well as visual, auditory, tactile displays and is not limited to a software interface.

Note 3 to entry: For the purposes of this standard, the manufacturer may treat the combination of ME equipment and other equipment as a single operator interface.

Note 4 to entry: See IEC 62366‑1:2015+AMD1:2020, 3.26.

[SOURCE: IEC 60601‑1‑6:2010+AMD2:2020 , 3.1]

201.3.271

operator's position

intended position of the operator with respect to the alarm signal generating part of the alarm system

Note 1 to entry: A distributed alarm system can have multiple operator’s positions.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.30]

201.3.272

outlet

opening through which gas leaves a device or component

[SOURCE: ISO 4135:2022 , 3.1.4.40]

201.3.273

patient-connection port

port of a breathing system intended for connection to an airway device

Note 1 to entry: The patient-connection port is the end of the breathing system proximal to the patient.

Note 2 to entry: The patient-connection port is typically a connector suitable for connection to an airway device such as a tracheal tube, tracheostomy tube, face mask or supralaryngeal airway.

Note 3 to entry: Current product standards typically specify that the patient-connection port is required to be in the form of specific standardized connectors, for example, a connector conforming to ISO 5356‑1.

[SOURCE: ISO 4135:2022 , 3.1.4.41, modified —deleted note 4.]

201.3.274

PEEP

positive end-expiratory pressure

<actual and measured value> respiratory pressure at the end of an expiratory phase

[SOURCE: ISO 19223:2019 , 3.10.4, modified — deleted notes.]

201.3.275

physiologic closed-loop control system

part of ME equipment or ME system used to adjust a physiologic variable (y) relative to a command variable (c) using a feedback variable (f)

[SOURCE: IEC 60601‑1‑10:2007+AMD2:2020 , 3.19]

201.3.276

physiological alarm condition

alarm condition arising from a monitored patient-related variable

EXAMPLE 1:

High exhaled anaesthetic agent concentration.

EXAMPLE 2:

Low exhaled tidal volume.

EXAMPLE 3:

Low oxygen saturation measured by pulse oximetry.

EXAMPLE 4:

High arterial pressure.

EXAMPLE 5:

High heart rate.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.31]

201.3.277

pressure-control

inflation-type that acts to generate a constant inspiratory pressure at a set level, after a set rise time

[SOURCE: ISO 19223:2019 , 3.3.4, modified — deleted notes.]

201.3.278

primary operating function

function that involves user interaction that is related to the safety of the medical device

Note 1 to entry: Often a primary operating function is interacted with by a series of tasks that can be broken down into a series of user interactions.

Note 2 to entry: The concept of safety includes loss or degradation of performance resulting in an unacceptable risk to the patient, including use error that prevents the user from effectively using the medical device to achieve its intended medical purpose. In IEC 60601‑1, this is referred to as essential performance.

[SOURCE: IEC 62366‑1:2015+AMD1:2020 , 3.11]

201.3.279

processing

<preparation of medical device, accessory> activity to prepare a new or used medical device and accessory for its intended use

[SOURCE: ISO 20417:2021 , 3.20]

201.3.280

professional healthcare facility

facility that is continually staffed by suitably trained healthcare professional operators

EXAMPLE:

Hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms, multiple treatment facilities and emergency medical services

[SOURCE: ISO 80601‑2‑12:2023 , 201.3.285, modified — deleted note.]

201.3.281

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

[SOURCE: ISO 80601‑2‑12:2023 , 201.3.286]

201.3.282

respiratory cycle

complete sequence of respiratory events that leads to an increase, followed by a corresponding decrease, of gas volume in the lung regardless of how it is generated

[SOURCE: ISO 19223:2019 , 3.4.16, modified — deleted notes.]

201.3.283

security level

level corresponding to the required set of countermeasures and inherent cybersecurity properties of devices and systems for a zone or conduit based on assessment of risk for the zone or conduit

[SOURCE: IEC/TR 60601‑4‑5:2021 , 3.23]

201.3.284

set rate

number of assured inflations that are set to occur in a specified period of time, expressed as breaths per minute

[SOURCE: ISO 19223:2019 , 3.5.1.1, modified — deleted notes and examples.]

201.3.285

single use

<medical device, accessory> intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of

Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again.

[SOURCE: ISO 20417:2021 , 3.26]

201.3.286

software item

any identifiable part of a computer program, i.e., source code, object code, control code, control data, or a collection of these items

Note 1 to entry: Three terms identify the software decomposition. The top level is the software system. the lowest level that is not further decomposed is the software unit. All levels of composition, including the top and bottom levels, can be called software items. A software system, then, is composed of one or more software items, and each software item is composed of one or more software units or decomposable software items. The responsibility is left to the manufacturer to provide the definition and granularity of the software items and software units.

[SOURCE: IEC 62304:2006+AMD1:2015 , 3.25, modified — deleted note 2.]

201.3.287

spontaneous breath rate

total number of spontaneous breaths initiated in a specified period of time, expressed as breaths per minute

[SOURCE: ISO 19223:2019 , 3.5.1.3, modified — deleted notes.]

201.3.288

standard temperature and pressure, dry

STPD

pressure of 101,325 kPa at a temperature of 20 °C, dry

Note 1 to entry: See also rationale for 201.5.101.2.

[SOURCE: ISO 4135:2022 , 3.1.1.8, modified — added note.]

201.3.289

sterile

free from viable microorganisms

[SOURCE: ISO 20417:2021 , 3.28]

201.3.290

sterilization

process used to render product free from viable microorganisms

Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero.

[SOURCE: ISO 17664‑1:2021 , 3.17]

201.3.291

symbol

graphical representation appearing on the label or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters (with sufficient justification).

[SOURCE: ISO 20417:2021 , 3.29]

201.3.292

system recovery

method for fault handling via an automatic restart of PESS for parts of the ME equipment or for the complete ME equipment

Note 1 to entry: There is guidance or rationale for this definition contained in Clause AA.2.

[SOURCE: ISO 80601‑2‑12:2023 , 201.3.298]

201.3.293

technical alarm condition

alarm condition arising from a monitored equipment-related or alarm system-related variable

EXAMPLE 1:

An electrical, mechanical or other failure.

EXAMPLE 2:

A failure of a sensor or component (unsafe voltage, high impedance, signal impedance, artefact, noisy signal, disconnection, calibration error, tubing obstruction, etc.).

EXAMPLE 3:

An algorithm that cannot classify or resolve the available data.

[SOURCE: IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 , 3.36]

201.3.294

technical description

portion of the accompanying information directed to the responsible organization and service personnel that is essential for preparation for the first use and safe use, maintenance or repair as well as processing, transport or storage for the expected service life of a medical device

Note 1 to entry: The technical description may be included in the instructions for use.

[SOURCE: ISO 20417:2021 , 3.30, modified — replaced 'expected lifetime' with 'expected service life' and deleted note 2.]

201.3.295

tidal volume

V _T

volume of gas that enters and leaves the lung during a breath

[SOURCE: ISO 19223:2019 , 3.8.1, modified — deleted notes.]

201.3.296

total respiratory rate

number of respiratory cycles in a specified period of time, expressed as breaths per minute

[SOURCE: ISO 19223:2019 , 3.5.1.2, modified — deleted notes.]

201.3.297

use environment

actual conditions and setting in which operators interact with the equipment

Note 1 to entry: The conditions of use or attributes of the use environment can include hygienic requirements, frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization. Social attributes such as team versus individual, chaotic versus calm, stress level and length of shift can also play a role.

[SOURCE: IEC 62366‑1:2015+AMD1:2020 , 3.20, modified — replaced "users" with "operators" and "medical device" with "equipment".]

201.3.298

use scenario

specific sequence of tasks performed by a specific operator in a specific use environment and any resulting response of the equipment

[SOURCE: IEC 62366‑1:2015+AMD1:2020 , 3.22, modified — replaced "user" with "operator" and "medical device" with "equipment".]

201.3.299

validation

confirmation, through the provision of objective evidence, that specified requirements 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 word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

[SOURCE: ISO 9000:2015 , 3.8.13]

201.3.300

ventilation

cyclical movement of a respirable gas into and out of the lungs

Note 1 to entry: This might be by external or spontaneous means, or by a combination of both.

[SOURCE: ISO 19223:2019 , 3.1.9, modified — deleted note 2.]

201.3.301

ventilation-mode

specified manner in which a ventilator performs its ventilatory function when connected to a patient

[SOURCE: ISO 19223:2019 , 3.11.2, modified — deleted notes.]

201.3.302

ventilator breathing system

VBS

pathways through which gas flows to or from the patient at respiratory pressures, bounded by the port through which respirable gas enters, the patient-connection port and the gas exhaust port

Note 1 to entry: These pathways typically extend within and outside the body of the ventilator, with those outside being operator-detachable.

Note 2 to entry: The port of entry of a respirable gas into the ventilator breathing system can be inside the body of the ventilator and should not be confused with an external connection port into which respirable gas enters before being reduced to respirable pressures.

[SOURCE: ISO 19223:2019 , 3.1.18, modified — deleted notes 3 and 4.]

201.3.303

ventilator-dependent

<patient> dependent upon artificial ventilation in order to prevent serious deterioration of health or death

Note 1 to entry: A ventilator-dependent patient cannot breathe well enough to maintain life-sustaining levels of oxygen and carbon dioxide in the blood.

EXAMPLE:

Patients with Duchenne muscular dystrophy or other degenerative disease resulting in their unsupported respiratory effort being insufficient to sustain life.

[SOURCE: ISO 4135:2022 , 3.1.5.19]

201.3.304

volume-control

inflation-type that generates inspiratory flow to a selected flow-waveform, for a set inspiratory-time, or until the set volume has been delivered

[SOURCE: ISO 19223:2019 , 3.3.3, modified — deleted notes.]

201.4 General requirements

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 4 applies, except as follows:

201.4.3 Essential performance

Addition:

201.4.3.101 Additional requirements for essential performance

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

Additional essential performance requirements are found in the subclauses listed in Table 201.101.

Table 201.101 — Distributed essential performance requirements

Requirement	Subclause
Delivery of ventilation at the patient-connection port within the alarm limits set by the operator or generation of an alarm condition
expired volume, if equipped	201.12.4.103
gas supply failure	201.13.102
high airway pressure	201.12.4.105
internal electrical power source depleted	212.8.2
inspiratory oxygen concentration, if equipped	201.12.4.101
system recovery	201.4.3.102
Subclauses 202.4.3.1 and 202.8.1.101 indicates methods of evaluating delivery of ventilation as acceptance criteria following specific tests required by this document.

201.4.3.102 Systemrecovery

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

a) Following a malfunction, the EMS ventilator shall attempt to perform a system recovery to restore essential performance of the EMS ventilator.

NOTE 2 An EMS ventilator or a subassembly function can become disturbed by a malfunction that could jeopardize the essential performance of the EMS ventilator. Without system recovery, the patient would have to be disconnected and connected to an alternative means of ventilation. Ventilation would thus be interrupted until an alternative means of ventilation is connected. System recovery, as specified in this subclause, attempts to automatically re-establish ventilation in a shorter period. If necessary, the EMS ventilator can be replaced later when it is less consequential for the patient's therapy.
b) System recovery may result in the temporary:
1. 1) cessation in the ventilation of the patient; or
2. 2) reduction in the function of EMS ventilator subassemblies without impacting the ventilation of the patient.
  
  EXAMPLE
  
  The temporary blanking of the display.
c) During a system recovery with a cessation of ventilation:
1. 1) the EMS ventilator shall allow spontaneous patient breathing in accordance with 201.103; and
2. 2) the EMS ventilator shall be equipped with an alarm system to indicate system recovery with a cessation of ventilation.
  1. i) The system recovery with a cessation of ventilation alarm condition shall be high priority.
d) During a system recovery without a cessation of ventilation, the EMS ventilator shall be equipped with an alarm system to indicate system recovery without a cessation of ventilation.
1. 1) The system recovery without a cessation of ventilation alarm condition shall be at least low priority.
2. 2) A low priority system recovery without a cessation of ventilation alarm condition need not have an auditory alarm signal.
e) Following a system recovery without operator intervention, the EMS ventilator shall attempt to operate with the same system configuration settings, ventilation settings and alarm settings as before the system recovery.
1. 1) If the system configuration settings, ventilation settings or alarm settings are different after the system recovery, the EMS ventilator shall be equipped with an alarm system to indicate any change in settings.
2. 2) The change in settings alarm condition shall be at least medium priority.
f) The duration of a system recovery with a cessation of ventilation should be as short as practicable to avoid an unacceptable risk to the patient.
g) The maximum duration of a system recovery of ventilation shall be disclosed in the instructions for use.

Check conformity by inspection of the instructions for use and functional testing.

201.4.4 Additional requirements for expected service life

Amendment (add as a second paragraph):

The manufacturer shall:

a) state the probability of component failure that results in the EMS ventilator needing to be taken out of service during the expected service life, assuming that the preventative inspection, preventive maintenance and calibration are performed according to the accompanying documents; and
b) summarize the methodology used to determine this probability.

Replacement (replace the compliance check):

Conformity is checked by inspection of the design documentation and the risk management file.

201.4.5 Alternative risk control measures or test methods for ME equipment or ME system

Amendment (add prior to the compliance check):

Subsequent revisions of dated references (new editions or amendments) may be used in substitution of a referenced document provided the manufacturer can demonstrate the hazard or hazardous situation addressed in the dated normative reference is adequately resolved in the subsequent revision.

201.4.6 ME equipment or ME system parts that contact the patient

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

Amendment (add at end of subclause):

aa) The VBS or its parts or accessories that can come into contact with the patient shall be subject to the requirements for applied parts in accordance with this subclause.

Addition:

201.4.11.101 Additional requirements for pressurized gas input

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

201.4.11.101.1 Overpressure requirement

a) An EMS ventilator shall:
1. 1) operate and meet the requirements of this document throughout its rated range of input pressure; and
2. 2) not cause an unacceptable risk under the single fault condition of an input pressure of 1 000 kPa.
b) An EMS ventilator with a maximum rated input pressure in excess of 600 kPa shall not cause an unacceptable risk under the single fault condition of twice the maximum rated input pressure.

NOTE 1 Internal pressure regulators can be required to accommodate the single fault condition of maximum input pressure as well as the rated range of input pressure.

NOTE 2 Under the single fault condition of overpressure, it is desirable for gas to continue to flow to the VBS. Under this condition, the flowrate from the EMS ventilator is likely to be outside of its specification.

Check conformity by functional testing in normal use and under normal condition with the most adverse operating settings, by functional testing in single fault condition and inspection of the risk management file for risks associated with overpressure conditions.

201.4.11.101.2 Compatibility requirement for medical gas pipeline systems

If the EMS ventilator is intended to be connected to a medical gas pipeline system conforming with ISO 7396‑1:2016+AMD1:2017, then:

a) the rated range of input pressure shall cover the range specified in ISO 7396‑1:2016+AMD1:2017; and

NOTE Taking account of requirements for over-pressure and under-pressure, this corresponds to a range 280 kPa to 600 kPa.
b) under normal condition,
1. 1) the maximum input flow required by the EMS ventilator for each gas shall not exceed 60 l/min averaged over 10 s, measured at the gas intake port with an input pressure of 280 kPa; and
2. 2) any transient input flow shall not exceed 200 l/min averaged for 3 s.
  
  or:
3. 3) the accompanying documents shall disclose:
  1. i) the maximum input flow required by the EMS ventilator for each gas at a pressure of 280 kPa averaged over 10 s, measured at the gas intake port;
  2. ii) the maximum transient input flow averaged for 3 s required by the EMS ventilator for each gas at a pressure of 280 kPa, measured at the gas intake port; and
  3. iii) a warning to the effect that this EMS ventilator is a high-flow device and should only be connected to a pipeline installation designed using a diversity factor that allows for the indicated high flow at a specified number of terminal outlets, in order to avoid exceeding the pipeline design flow, thereby minimising the risk that the EMS ventilator interferes with the operation of adjacent equipment.

Check conformity by functional testing in normal use and under normal condition with the most adverse operating settings and by inspection of the accompanying documents.

EXAMPLE

Highest driving gas consumption under worst-case settings for set rate and tidal volume within the rated range for inlet pressure.

201.4.11.101.3 Compatibility requirements for pressure regulators

If the EMS ventilator is intended to be connected to an oxygen gas cylinder via a pressure regulator then:

a) the rated range of input pressure shall cover the range specified in:
1. 1) ISO 10524‑1:2018 ; or
2. 2) ISO 10524‑3:2019 ; and
b) Under normal condition, the 10 s average input flow required by the EMS ventilator for oxygen shall not exceed 40 l/min at a pressure of 360 kPa, measured at the gas intake port.

Check conformity by functional testing in normal use and under normal condition with the most adverse operating settings and by inspection of the accompanying documents.

EXAMPLE

Highest driving gas consumption, highest fresh gas delivery and, if provided, the highest rated gas consumption at any gas power supply output.

201.5 General requirements for testing of ME equipment

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 5 applies, except as follows:

Addition:

201.5.101 Additional requirements for general requirements for testing of ME equipment

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

201.5.101.1 EMS ventilator test conditions

a) For testing, the EMS ventilator:
1. 1) shall be connected to gas supplies as specified for normal use;
2. 2) except that industrial grade oxygen and air may be substituted for the equivalent medical gas, as appropriate, unless otherwise stated.
  
  NOTE There is guidance or rationale for this list item contained in Clause AA.2.
b) When using substitute gases, care should be taken to ensure that the test gases are oil-free and appropriately dry.

201.5.101.2 Gas flowrate and leakage specifications

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

All requirements for gas flowrate, volume and leakage in this document

a) are expressed at STPD,
b) except for those associated with the VBS, which are expressed at BTPS.

Correct all test measurements to STPD or BTPS, as appropriate.

201.5.101.3 EMS ventilator testing errors

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

a) For the purposes of this document, acceptance criteria for declared tolerances of testing shall use:
1. 1) procedure 1 (calculation of uncertainty of measurement) from IEC Guide 115:2021, 4.4.2; or
2. 2) procedure 2 (accuracy method) from IEC Guide 115:2021, 4.4.3.
  
  NOTE 2 This is a change from previous revisions of this document, which required tolerances to be adjusted by subtracting measurement uncertainty from disclosed tolerance values to determine acceptance criteria.
b) Test equipment and methods shall be selected and controlled to ensure that the uncertainty (with coverage factor k = 2, for confidence of ~ 95%) is no more than 30% of the disclosed tolerance for the parameter being tested.

EXAMPLE

If the manufacturer wishes to claim a tolerance for delivered volume of ±(10 ml +10 % of set volume) then the uncertainty of the measurement cannot exceed ±(3 ml +3 % of set volume).
c) The manufacturer shall disclose the measurement uncertainty for each disclosed tolerance in the technical description.

Check conformity by inspection of the technical description.

201.6 Classification of ME equipment and ME systems

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 6 applies.

201.7 ME equipment identification, marking and documents

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 7 applies, except as follows:

Addition:

201.7.1.101 Information to be supplied by the manufacturer

a) The information supplied by the manufacturer of an EMS ventilator and its accessories shall conform with ISO 20417:2021.
b) In applying ISO 20417:2021, the terms in this document and those in IEC 60601‑1:2005+AMD1:2012+AMD2:2020 shall be used as follows.
1. 1) The term "accompanying information" shall assume the same meaning as accompanying documents.
2. 2) The term "medical device" shall assume the same meaning as ME equipment.
3. 3) The term "user" shall assume the same meaning as operator.
4. 4) The term "patient" shall include animals.

Check conformity by application of ISO 20417:2021.

201.7.2.3 Consult accompanying documents

Replacement:

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

The EMS ventilator shall be marked with the safety sign for the mandatory action: “follow instructions for use”, ISO 7010‑M002 (see IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Table D.2, safety sign 10).

Addition:

201.7.2.4.101 Additional requirements for accessories

a) Accessories supplied separately shall:
1. 1) fulfil the marking requirements of ISO 20417:2021, 6.1.1 c); and
2. 2) be marked with an indication of any limitations or adverse effects of the accessory on the basic safety or essential performance of the EMS ventilator, if applicable. See also 201.7.2.101.
b) If marking the accessory is not practicable, this information may be placed in the instructions for use.

Check conformity by inspection, inspection of the risk management file for any limitations or adverse effects of the accessory, if applicable, and when necessary, inspection of the instructions for use.

201.7.2.18 External gas source

Amendment (add before the first dash):

aa) the gas name or chemical symbol in accordance with ISO 5359:2014+AMD1:2017,
bb) the rated range of gas pressure,
cc) for oxygen gas inputs, the rated range of oxygen concentration,
dd) gas-specific colour coding in accordance with ISO 32:1977, if colour coding is used,

EXAMPLE

Colour coding to match the colour of the flexible supply hose or a gas cylinder intended to be attached to the connector of the inlet.

NOTE In some countries, other colour coding is used.

Addition:

201.7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

a) The EMS ventilator shall be provided with a clearly legible permanently attached start-up procedure that is intended to be performed prior to use.
b) The start-up procedure may be provided electronically.

EXAMPLE

A start-up procedure provided on the graphical operator interface or provided orally.
c) If applicable, operator-accessible ME equipment, parts or accessories shall have clearly legible markings of the following
1. 1) for an EMS ventilator intended to be used in the magnetic resonance (MR) environment, in accordance with IEC 62570:2014,
  1. i) symbol 7.3.1-1 (Table 201.D.2.101, symbol 3) or symbol 7.3.1-2 (Table 201.D.2.101, symbol 4) of IEC 62570:2014 for an ‘MR Safe’ EMS ventilator, or
  2. ii) symbol 7.3.2 (Table 201.D.2.101, symbol 5) of IEC 62570:2014 for an ‘MR Conditional’ EMS ventilator,
2. 2) for an EMS ventilator not intended to be used in the magnetic resonance (MR) environment, in accordance with IEC 62570:2014, symbol 7.3.3 (Table 201.D.2.101, symbol 6) for an ‘MR Unsafe’ EMS ventilator
3. 3) for flow-direction-sensitive components that are operator-removable without the use of a tool, an arrow indicating the direction:
  1. i) of the flow; or
  2. ii) of inspiratory flow if exposed to inspiratory and expiratory flow.
d) If applicable, operator-accessible ME equipment, parts or accessories shall have clearly legible markings of the following on or adjacent to the following items:
1. 1) a warning not to obstruct the gas intake port.
  
  EXAMPLE 1
  
  WARNING: Gas Intake — Do not obstruct
  1. i) A symbol or safety sign evaluated in accordance with to IEC 62366‑1 as information for safety may be used.
2. 2) an arrow indicating the intended direction of gas flow:
  1. i) for the gas output port; and
    
    I) Symbol 0795 of ISO 7000 (Table 201.D.2.101, symbol 2) may be used for gas output port.
  2. ii) for the gas return port.
    
    I) Symbol 0794 of ISO 7000 (Table 201.D.2.101, symbol 1) may be used for gas return port.
3. 3) for a sampling gas inlet, either with the text “Gas sample” or the SymbolISO 7000‑0794, (Table 201.D.2.101, symbol 1).
  
  EXAMPLE 2
  
  Input to a diverting respiratory gas monitor integrated into the EMS ventilator.

201.7.4.2 Control devices

Amendment (add between the first and second paragraph):

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

aa) An EMS ventilator with an oxygen concentration control with an error exceeding 20 % [see 201.12.1.101 b) 3) and 201.12.1.102 b) 3) ] shall not be marked with quantitative numerical concentration values.

EXAMPLE

“No air mix” or “High” for the setting for the maximum achievable oxygen concentration or “Air mix” or “Low” for the setting with a reduced oxygen concentration.

Check conformity by inspection.

201.7.4.3 Units of measurement

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

Amendment (add to the bottom as a new row in Table 1):

All gas volume, flowrate and leakage specifications:

aa) shall be expressed at STPD; except for those associated with the VBS which
bb) shall be expressed at BTPS.

Addition:

201.7.4.101 Labelling of units of measurement

Quantitative numeric indications of parameters and settings shall be labelled with the units of measurement, either:

a) continuously; or
b) on operator action.

201.7.9.2.1 General

Amendment (add as fifth bullet following the first paragraph):

— the intended position of the operator;

201.7.9.2.1.101 Additional general requirements

The instructions for use shall disclose the following:

a) the intended range of inspiratory volume.

Check conformity by inspection.

201.7.9.2.2.101 Additional requirements for warnings and safety notices

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

a) The instructions for use shall include:
1. 1) a warning statement to the effect of “Warning: This ventilator is intended to be continuously attended by an operator. Failure to be in close proximity to this ventilator can contribute to patient death or serious injury.”
2. 2) a warning statement to the effect of “Warning: Do not cover the ventilator or place in a position that affects proper operation”, including applicable examples.
  
  EXAMPLE 1
  
  WARNING: Do not position next to a blanket that blocks the flow of cooling air, thereby causing the ventilator to overheat, thereby interfering with patient ventilation.
  
  EXAMPLE 2
  
  WARNING: Do not block the gas intake port thereby interfering with patient ventilation.
3. 3) a warning statement to the effect of “Warning: Always have immediate access to an alternative means of ventilation, which is ready for use, in order to reduce the possibility of patient death or additional deterioration of health.”
  
  EXAMPLE 3
  
  WARNING: Failure to have an alternative means of ventilation such as a self-inflating, manually powered resuscitator (as specified in ISO 10651‑4) with mask can result in patient death if the ventilator fails.
4. 4) a warning statement to the effect of “WARNING: Do not add any attachments or accessories to the ventilator that are not listed as intended for use in combination with the ventilator in the instructions for use of the ventilator or accessory, as the ventilator might not function correctly leading to the risk of patient death or additional serious deterioration of health.”
b) If applicable, the instructions for use shall include the following:
1. 1) a warning statement to the effect of “WARNING: When using nebulisation or humidification, the breathing system filters can require more frequent replacement to prevent increased resistance and blockage.
2. 2) a warning statement to the effect of “Warning: The ventilator shall not be used in a hyperbaric chamber. Such use might cause the ventilator to not function correctly causing patient death or additional serious deterioration of health.”
3. 3) a warning statement to the effect of “Warning: The ventilator accuracy can be affected by the gas added to the ventilator breathing system by use of a pneumatic nebuliser.
4. 4) a warning statement to the effect of “Warning: Do not use the ventilator in explosive environments. Such use might cause an explosion.”

Check conformity by inspection.

201.7.9.2.8.101 Additional requirements for start-up procedure

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

NOTE 2 A start-up procedure includes a pre-use functional test that is used to determine whether the EMS ventilator is ready for use.

a) The instructions for use or the operator interface shall include a pre-use checklist.
b) The instructions for use shall disclose a method by which all of the alarm signals can be functionally tested by the clinical operator to determine if they are operating correctly.
c) Portions of this test method may:
1. 1) be automatically performed by the EMS ventilator; or
2. 2) require operator action.
  
  EXAMPLE
  
  Combination of the power-on self-test routines and operator action.

Check conformity by inspection of the instructions for use.

201.7.9.2.9.101 Additional requirements for operating instructions

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

The instructions for use shall disclose:

a) a listing of the following pressures:
1. 1) the range of maximum limited pressure (P_{LIM
  max});
2. 2) if provided, the rated range to which the maximum working pressure (P_W_max) can be set, if adjustable;
3. 3) the means by which the maximum working pressure is accomplished.
  
  EXAMPLE 1
  
  Pressure cycling, pressure limiting, pressure generation.
b) the rated range of the following characteristics of the assembled operator-detachable parts of the VBS, over which the accuracies of set and monitored volumes and pressures are maintained:
1. 1) inspiratory gas pathway resistance,
2. 2) expiratory gas pathway resistance, and
3. 3) VBS compliance.
  1. i) These specifications may be presented in ranges.
  2. ii) The accuracies of set and monitored volumes may be presented as a function of these characteristics.
    
    NOTE 2 Compliance and resistance can be non-linear. These characteristics might need to be specified over a range (e.g. at 15 l/min, 30 l/min, 60 l/min and the maximum flowrate or the maximum pressure).
c) the conditions under which the EMS ventilator maintains the accuracy of controlled and displayed variables as disclosed in the instructions for use.

EXAMPLE 2

Interval of calibration of a flow sensor.
d) if end-tidal gas concentration measurement is provided, a summary of effects of respiratory rate on the end-tidal gas concentration measurement accuracy.
e) if a connection for a distributed alarm system is provided, a description of how to connect and test the connection of a distributed alarm system.
f) a cross reference between the manufacturer-specific naming of the EMS ventilator's ventilation-modes and the ventilation-mode systematic coding scheme in Annex E of ISO 19223:2019.
g) whether or not the EMS ventilator is intended for use with closed suctioning.

Check conformity by inspection.

201.7.9.2.12 Cleaning, disinfection, and sterilization

Amendment: (add after normal use)

or in single fault condition

Amendment: (add after bulleted list)

aa) The instructions for use shall identify which portions of the gas pathways through the EMS ventilator can become contaminated with body fluids or by microbial material conveyed by the expired breathing gases during both normal condition and single fault condition.

Addition:

201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

a) The instructions for use of the EMS ventilator shall identify:
1. 1) at least one set of accessories; and
2. 2) if applicable, the ME equipment necessary for the EMS ventilator’s intended use.
b) If applicable, the instructions for use of the EMS ventilator shall disclose:
1. 1) any restrictions on the positioning of components within the ventilator breathing system; and
  
  EXAMPLE
  
  Where such components are flow-direction-sensitive components.
2. 2) any reasonably foreseeable adverse effect of any recommended accessory on the essential performance or basic safety of the EMS ventilator (additional requirements are found in 201.16).

Check conformity by inspection of the instructions for use and inspection of the risk management file for any adverse effect of any recommended accessory.

201.7.9.3.1.101 Additional general requirements

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

a) The technical description shall disclose:
1. 1) a summary description of the filtering or smoothing techniques for all measured or computed variables that are displayed or used for control necessary for the operator to form a mental model of the operation of the EMS ventilator;
2. 2) a pneumatic diagram of the EMS ventilator, including a diagram for operator-detachable parts of the ventilator breathing system either supplied or recommended in the instructions for use;
3. 3) a summary description of the means of initiating and terminating the inflation phase in each ventilation-mode of the EMS ventilator; and
4. 4) the outside dimensions and mass of the EMS ventilator.
b) If applicable, the technical description shall disclose:
1. 1) the essential technical characteristics of each recommended breathing system filter; and
  
  EXAMPLE
  
  Deadspace and resistance.
2. 2) a description of the method used to calculate end-tidal gas readings.

Check conformity by inspection.

201.7.9.3.101 Additional requirements for the technical description

The technical description shall disclose:

a) a description of a procedure for checking the functioning of the alarm system for each of the alarm conditions specified in this document, if not performed automatically during start-up; and
b) which checks are performed automatically.

Check conformity by inspection of the technical description.

201.8 Protection against electrical hazards from ME equipment

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 8 standard applies.

201.9 Protection against mechanical hazards of ME equipment and ME systems

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 9 applies, except as follows:

Addition:

201.9.4.3.101 Additional requirements for instability from unwanted lateral movement

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

a) An EMS ventilator shall include a means by which the EMS ventilator can be attached to prevent unwanted movement during transport while in use.
b) The means shall secure the EMS ventilator to withstand accelerations or decelerations of
1. 1) 10 g longitudinal (forward, backward), 10 g transverse (left, right) and 10 g vertical (up, down) for at least 150 ms in each orientation for a road ambulance.
2. 2) 20 g longitudinal (forward, backward), 20 g transverse (left, right), 20 g vertical (down) and 4 g vertical (up) for at least 3 s in each orientation for an air ambulance.
c) Terminal units and electrical sockets shall not be used as part of the fixation system.
d) If rail systems are used, they shall conform with ISO 19054:2005+AMD1:2016.

NOTE 2 Rail systems consist of e.g. rail supports, rails, rail clamps, equipment mount holders, equipment mounts, equipment pin holders and equipment pins.
e) The means to secure a portable EMS ventilator to withstand forces caused by accelerations or decelerations shall be operable without the use of a tool.
f) The technical description shall disclose the technical details of this means for attachment.

Check conformity by inspection and functional testing.

EXAMPLE

These tests can be performed by using static loading, acceleration sleds or centrifuges.

201.9.4.4 Grips and other handling devices

Replace list item b) with:

b) A portable EMS ventilator shall be designed such that it can be carried by no more than one hand.
1. 1) It shall be possible for the operator to:
  1. i) observe the display;
  2. ii) recognize the alarm signals; and
  3. iii) actuate the controls while holding the EMS ventilator with no more than one hand.
2. 2) A carrying case or handle may be used to fulfill this requirement.

Amendment (add to the end of the compliance check):

Check conformity by functional testing while carrying with no more than one hand.

201.9.6.2.1.101 Additional requirements for audible acoustic energy

a) The A-weighted sound pressure level emitted by the EMS ventilator shall be:
1. 1) measured in accordance with ISO 4871:1996 and ISO 3744:2010 using engineering method grade 2; and
2. 2) disclosed in the instructions for use.
b) The A-weighted sound power level shall be:
1. 1) calculated in accordance with 8.2.5 and 8.6 of ISO 3744:2010; and
2. 2) disclosed in the instructions for use.
c) Check conformity with the following test:
1. 1) Place the EMS ventilator on the sound-reflecting plane and attach the least favourable VBS from those indicated in the instructions for use.
  
  NOTE 1 The least favourable VBS configuration can vary by ventilation-mode, inflation-type and flow pattern, as applicable.
2. 2) If a humidifier is provided with the EMS ventilator, include the humidifier filled to the least favourable level in the test.
3. 3) Configure the test lung with the compliance and resistance components whose values are indicated in Table 201.102.
  1. i) Acoustically isolate the test lung by a suitable means so that any noise caused by the test lung does not interfere with the sound measurement of the EMS ventilator.
  2. ii) Connect the patient-connection port to the test lung.
4. 4) Set the EMS ventilator to the least favourable ventilation-mode, inflation-type and flow pattern, as applicable, that generates ventilation as indicated in Table 201.102.
  
  NOTE 2 The least favourable ventilation-mode, inflation-type and flow pattern can vary by VBS configuration.
5. 5) Using a microphone of the sound level meter, conforming with the requirements of type 1 instruments specified in IEC 61672‑1:2013, measure the maximum time-weighted sound pressure level using frequency-weighting A and the time-weighting F of the sound level meter (i.e. L_AFmax) at 10 positions in a hemisphere with a radius from the geometric centre of the EMS ventilator in a free field over a reflecting plane as specified in 8.1.1 of ISO 3744:2010. Average the values in accordance with 8.2.2 of ISO 3744:2010.
6. 6) Calculate the A-weighted sound pressure level averaged over the measurement surface in accordance with 8.2.2 of ISO 3744:2010.
7. 7) Calculate the A-weighted sound power level in accordance with 8.6 of ISO 3744:2010.
8. 8) Confirm that the criteria for background noise specified in 4.2 of ISO 3744:2010 are fulfilled.
9. 9) Ensure that the average measured sound pressure level is less than or equal to that disclosed in the instructions for use.
10. 10) Ensure that the sound power level is less than that disclosed in the instructions for use.

Table 201.102 — Test conditions for acoustic tests

Adjustable parameter	Test condition
	For an EMS ventilator intended to provide tidal volume
	V _T ≥300 ml	300 ml ≥ V_T ≥50 ml	V _T ≤50 ml
Tidal volume , V_Ta	500 ml	150 ml	30 ml
Set rate	10 breaths/min	20 breaths/min	30 breaths/min
I:E ratio	1:2	1:2	1:2
BAP	10 hPa	10 hPa	10 hPa
Linear resistance, Rb^[43][53][56]	5 hPa·(l/s)^‒1 +10 %	20 hPa·(l/s)^‒1 ±10 %	50 hPa·(l/s)^‒1 ±10 %
Isothermal Compliance, Cb	50 ml/hPa ±5 %	20 ml/hPa ±5 %	1 ml/hPa ±5 %

a V _T is measured by means of a pressure sensor at the test lung, where V_T = C (P_max - P_min), and

V _T is the volume delivered to the test lung
C is the Isothermal Compliance of the test lung
P _max is the maximum pressure measured in the test lung
P _min is the minimum pressure measured in the test lung.

b The accuracy for C and R applies over the ranges of the measured parameters.

NOTE There is guidance or rationale for this table contained in Clause AA.2.

201.10 Protection against unwanted and excessive radiation hazards

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 10 applies.

201.11 Protection against excessive temperatures and other hazards

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 11 applies, except as follows:

201.11.1.2.2 Applied parts not intended to supply heat to a patient

NOTE There is guidance or rationale for this subclause contained in Clause AA.2.

Amendment (add between the existing paragraphs):

In normal use and single fault conditions and over the rated flowrate range and at the maximum rated operating temperature, the temperature of the gas delivered by the EMS ventilator at the patient-connection port, both with and without each humidifier specified for use in the instructions for use, when averaged over 120 s shall not exceed:

aa) 70 °C; and
bb) an energy equivalent to 43 °C and 100 % relative humidity (a specific enthalpy not to exceed 197 kJ/m³ dry air).

Table 201.103 contains examples of combinations of temperature and relative humidity with such a specific enthalpy.

Table 201.103 — Examples of permissible combinations of temperature and relative humidity

Temperature °C	Relative humidity %
43	100
44	95
45	90
48	76
50	69
55	52
60	40
65	30
70	23

201.11.6.6 Cleaning and disinfection of ME equipment or ME system

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

Amendment (add additional requirement as new first paragraph):

aa) Gas pathways through the EMS ventilator and its accessories not intended for single use that can become contaminated with body fluids or by microbial material conveyed by the expired gases during normal condition or single fault condition shall be designed to allow for:
1. 1) cleaning and disinfection; or
2. 2) cleaning and sterilization.
  
  NOTE 2 Additional sterilization requirements are found in 11.6.7 of IEC 60601‑1:2005+AMD1:2012+AMD2:2020.
bb) Processing instructions for the gas pathways of the EMS ventilator and its accessories that can become contaminated shall:
1. 1) conform with ISO 17664‑1:2021;
2. 2) conform with ISO 14937:2009, if applicable; and
3. 3) be disclosed in the instructions for use.

Amendment (add additional requirement as the last requirement and replace the compliance test):

cc) EMS ventilator enclosures shall be designed to allow for surface cleaning and disinfection to reduce to acceptable levels the risk of cross infection of the next patient.

NOTE 3 ISO 14159 provides guidance for the design of enclosures.
dd) Processing instructions for the EMS ventilator enclosure shall:
1. 1) conform with ISO 17664‑2:2021; and
2. 2) be disclosed in the instructions for use.

Check conformity by inspection of the risk management file to determine the gas pathways that can become contaminated in normal condition and single fault condition and conformity with ISO 17664‑1:2021 and ISO 17664‑2:2021, as appropriate. When conformity with this document could be affected by the cleaning or the disinfection of the EMS ventilator or its parts or accessories, clean and disinfect them for the number of processing cycles and in accordance with the methods indicated in the instructions for use, including any cooling or drying period. After these procedures, ensure that basic safety and essential performance are maintained. Confirm that the manufacturer has evaluated the effects of multiple processing cycles and the effectiveness of those cycles.

201.11.6.7 Sterilization of ME equipment or ME system

Amendment (add note before compliance test):

NOTE Additional sterilization requirements are found in 11.6.6 of IEC 60601‑1:2005+AMD1:2012+AMD2:2020.

201.11.7 Biocompatibility of ME equipment and ME systems

Amendment (add after existing text prior to the compliance statement):

aa) The manufacturer of an EMS ventilator, VBS, its parts and accessories shall address in the risk management process the risks associated with the leaching or leaking of substances into the gas pathway.
bb) The gas pathways shall be evaluated for biocompatibility in accordance with to ISO 18562‑1:2023.

BS EN ISO 80601-2-84:2023

Medical electrical equipment - Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

Current

Published:

30 Nov 2023