ISO/TS 17430
(Main)Patient compartment of negative pressure ambulance — Technical specifications
Patient compartment of negative pressure ambulance — Technical specifications
This standard specifies the relevant terms and definitions, technical requirements, and test methods for the medical cabin of negative pressure ambulances. This standard applies to ambulances equipped with negative pressure systems
Compartiment patient pour ambulance à pression négative — Spécifications techniques
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FINAL DRAFT
Technical
Specification
ISO/DTS 17430
ISO/TC 22/SC 40
Patient compartment of negative
Secretariat: UNI
pressure ambulance — Technical
Voting begins on:
specifications
2024-11-27
Compartiment patient pour ambulance à pression négative —
Voting terminates on:
Spécifications techniques
2025-01-22
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 17430:2024(en) © ISO 2024
FINAL DRAFT
ISO/DTS 17430:2024(en)
Technical
Specification
ISO/DTS 17430
ISO/TC 22/SC 40
Patient compartment of negative
Secretariat: UNI
pressure ambulance — Technical
Voting begins on:
specifications
Compartiment patient pour ambulance à pression négative —
Voting terminates on:
Spécifications techniques
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 17430:2024(en) © ISO 2024
ii
ISO/DTS 17430:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for patient compartment . 2
5 Special requirements for patient compartment . 2
5.1 Sealing and isolation requirements .2
5.2 Requirements for performance of negative pressure .2
5.3 Ventilation frequency requirements .2
5.4 Air directional collection efficiency requirements .2
5.5 Requirements for disinfection system .2
5.6 Requirements for filtration equipment of negative pressure system .3
5.7 Requirements for disinfection device of negative pressure system .3
6 Marking . . 3
7 Manual . 4
8 Test methods . 4
8.1 Sealing performance test .4
8.2 Negative pressure performance test .4
8.3 Ventilation rate test . .4
8.4 Air directional collection efficiency requirements .5
8.4.1 Test equipment and facilities .5
8.4.2 Test procedures .5
8.4.3 Test results .6
8.5 Test for disinfection system.6
8.6 Verification for performance of the filtration device of negative pressure system .6
8.7 Verification for result of disinfection device of negative pressure system .6
Bibliography . 7
iii
ISO/DTS 17430:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 22, Road vehicles, Subcommittee SC 40, Specific
aspects for light and heavy commercial vehicles, busses and trailers.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DTS 17430:2024(en)
Introduction
According to the data from World Health Organization, there have been large-scale outbreaks of respiratory
infectious diseases in the past decades, such as SARS, bird flu, H1N1, MERS, CoVID-19, etc., posing a huge
challenge to the public health system. In the fight against respiratory diseases, the concept of negative
pressure ambulances was initiated by public health and epidemic experts. For the establishment and
improvement of the public health emergency rescue system, we have studied the negative pressure
ambulance products with global experts.
A negative pressure ambulance is defined as an ambulance fitted with negative pressure and sterilization
equipment, used for the care, monitoring and transportation for respiratory disease patients. It provides
treatment for patients, isolates sources of transmission and prevents cross infection effectively. Due to
the highly contagious nature of respiratory viruses, conventional ambulances are not up to the task of
transporting. Compared with conventional ambulances, negative pressure ambulances can effectively
block airborne transmission, greatly reduce the risk of infection for medical and public personnel, as well
as the contamination of the surrounding environment, effectively ensuring the safe transport of respiratory
infection patients.
As a special type of ambulance, the difference between a negative pressure ambulance and any other
conventional ambulance mainly lies in the patient compartment, which has functions such as blocking
the source of infection, disinfecting and sterilizing, preventing cross-infection and many others. In the
state of the art, there are no special, systematic and unified technical requirements for negative pressure
ambulances globally. During the production and use phase, the absence of unified regulations and unbalanced
standards for the negative pressure ambulance, especially for its patient compartment, causes great trouble
to the production and leading the risk of use. For the safe use of negative pressure ambulances, it is of
great significance to develop a technical specification for the patient compartment of negative pressure
ambulances in the ISO system as a global reference in line with their differences and characteristics. This
document mainly involves the special requirements and test methods of the patient compartment, including
sealing and isolation, negative pressure, ventilation rate, directional airflow, sterilization system, filtration,
and sterilization device of the negative pressure system. Relative technical standards and test methods are
fully in accordance with the needs of the medical and health industry, to improve the technical level of the
products and provide safer services in the transfer of patients, and promote effective and timely treatment
of patients in the epidemic environment.
In summary, forming a set of global, unified, formal negative pressure ambulance technical specifications
of patient compartments could have a positive impact on controlling infectious respiratory diseases around
the world, reduce the risk of transmission and can better protect medical workers and the surrounding
environment.
v
FINAL DRAFT Technical Specification ISO/DTS 17430:2024(en)
Patient compartment of negative pressure ambulance —
Technical specifications
1 Scope
This document specifies the relevant terms and definitions, technical requirements and test methods for the
patient compartment of negative pressure ambulances.
This document is applicable to ambulances equipped with negative pressure systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all their content constitutes
the 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 12219-1, Interior air of road vehicles — Part 1: Whole vehicle test chamber — Specification and method for
the determination of volatile organic compounds in cabin interiors
EN 1789:2020, Medical vehicles and their equipment — Road ambulances
3 Term
...
© ISO####-All rights reserved
ISO/DTS 17430:####(X)
ISO/TC 22/SC 40/WG3
Secretariat: XXXX UNI
Date: 2024-11-12
Patient Compartmentcompartment of Negative Pressure Ambulance
negative pressure ambulance — Technical
Specificationsspecifications
WD/CD/DIS/FDIS stage
Warnings during WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change
without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
To help you, this guide on writing standards was produced by the ISO/TMB and is available at:
A model manuscript of a draft International Standard (known as "The Rice Model") is available at:
ISO #####-#:####(X)
Compartiment patient pour ambulance à pression négative — Spécifications techniques
2 © ISO #### – All rights reserved
ISO #####-#:####(X)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Address: CP 401 • Ch. de Blandonnet 8CH8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: +41 22 749 09 47
Email: E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
v
ISO #####-#:####(X)
Contents
Foreword . iv
Introduction . vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for patient compartment . 2
5 Special requirements for patient compartment . 2
5.1 Sealing and isolation requirements . 2
5.2 Requirements for performance of negative pressure . 2
5.3 Ventilation frequency requirements . 2
5.4 Air directional collection efficiency requirements. 2
5.5 Requirements for disinfection system . 3
5.6 Requirements for filtration equipment of negative pressure system . 3
5.7 Requirements for disinfection device of negative pressure system . 3
6 Marking . 3
7 Manual . 4
8 Test methods . 4
8.1 Sealing performance test . 4
8.2 Negative pressure performance test. 5
8.3 Ventilation rate test . 5
8.4 Air directional collection efficiency requirements. 5
8.5 Test for disinfection system . 7
8.6 Verification for performance of the filtration device of negative pressure system . 7
8.7 Verification for result of disinfection device of negative pressure system . 7
Bibliography. 8
Bibliography. 6
iv © ISO #### – All rights reserved
ISO #####-#:####(X)
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 documentsdocument 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).
Please noteISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of
this document, ISO had not received notice of (a) patent(s) which may be required to implement this
document. However, implementers are cautioned that this may not represent the latest information,
which may be obtained from the patent database available at www.iso.org/patents 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 .
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO -specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 22, Road vehicles, Subcommittee SC 40,
Specific aspects for light and heavy commercial vehicles, busses and trailers.
Any feedback or questions abouton this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at
www.iso.org/members.htmlwww.iso.org/members.html.
v
ISO #####-#:####(X/DTS 17430:(en)
.
© ISO ####2024 – All rights reserved
vi
ISO #####-#:####(X/DTS 17430:(en)
Introduction
According to the data from World Health Organization, there have been large-scale outbreaks of respiratory
infectious diseases in the past decades, such as SARS, bird flu, H1N1, MERS, CoVID-19, etc., posing a huge
challenge to the public health system. In the fight against respiratory diseases, the concept of negative
pressure ambulances was initiated by public health and epidemic experts. For the establishment and
improvement of the public health emergency rescue system, we have studied the negative pressure ambulance
products with global experts.
A negative pressure ambulance is defined as an ambulance fitted with negative pressure and sterilization
equipment, used for the care, monitoring and transportation for respiratory disease patients. It provides
treatment for patients, isolates sources of transmission and prevents cross infection effectively. Due to the
highly contagious nature of respiratory viruses, conventional ambulances are not up to the task of
transporting. Compared with conventional ambulances, negative pressure ambulances can effectively block
airborne transmission, greatly reduce the risk of infection for medical and public personnel, as well as the
contamination of the surrounding environment, effectively ensuring the safe transport of respiratory infection
patients.
As a special type of ambulance, the difference between a negative pressure ambulance and any other
conventional ambulance mainly lies in the patient compartment, which has functions such as blocking the
source of infection, disinfecting and sterilizing, preventing cross-infection and many others. In the state of the
art, there are no special, systematic and unified technical requirements for negative pressure ambulances
globally. During the production and use phase, the absence of unified regulations and unbalanced standards
for the negative pressure ambulance, especially for its patient compartment, causingcauses great trouble to
the production and leading the risk of use. For the safe use of negative pressure ambulances, it is of great
significance to develop a technical specification for the patient compartment of negative pressure ambulances
in the ISO system as a global reference in line with their differences and characteristics. This document mainly
involves the special requirements and test methods of the patient compartment, including sealing and
isolation, negative pressure, ventilation rate, directional airflow, sterilization system, filtration, and
sterilization device of the negative pressure system. Relative technical standards and test methods are fully in
accordance with the needs of the medical and health industry, to improve the technical level of the products
and provide safer services in the transfer of patients, and promote effective and timely treatment of patients
in the epidemic environment.
In summary, forming a set of global, unified, formal negative pressure ambulance technical specifications of
patient compartments could have a positive impact on controlling infectious respiratory diseases around the
world, reduce the risk of transmission and can better protect medical workers and the surrounding
environment.
v© ISO 2024 – All rights reserved
vii
ISO #####-#:####(X/DTS 17430:(en)
Patient Compartmentcompartment of Negative Pressure Ambulance
negative pressure ambulance — Technical Specificationsspecifications
1 1 Scope
This document specifies the relevant terms and definitions, technical requirements, and test methods for the
patient compartment of negative pressure ambulances.
This document is applicable to to ambulances equipped with negative pressure systems.
2 2 Normative Referencesreferences
The following documents are referred to in the text in such a way that some or all their content constitutes the
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 12219-1, Interior air of road vehicles — Part 1: Whole vehicle test chamber — Specification and method for
the determination of volatile organic compounds in cabin interiors
ISO 29463-1:2011, High-efficiency air filters and filter media for removing particles in air - Part 1: Classification,
performance testing and marking
EN 1789:2020-12,, Medical vehicles and their equipment — Road ambulances
3 3 Terms and Definitionsdefinitions
For the purposes of this document, the following terms and definitions 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/
3.1 3.1
ambulance
vehicle used to treat, monitor and transfer at least one patient, and is equipped with at least 2 two seats for
trained personnel
3.2 3.2
negative pressure ambulance
type of medical emergency vehicle equipped with negative pressure and disinfection facilities with the
purpose to cure, monitor and transfer persons with respiratory infectious diseases
© ISO ####2024 – All rights reserved
ISO #####-#:####(X/DTS 17430:(en)
3.3 3.3
negative pressure system
device that achieves an air pressure below a specified value of atmospheric pressure in a medical
compartment and has the function of targeted collection and disinfection of exhaled air from patients with
respiratory infectious diseases
Note 1 to entry: It usually consists of a negative pressure fan, a filtration device, a disinfection device and a gas collection
device.
3.4 3.4
patient compartment
internal area of the negative pressure ambulance (3.2) which is equipped with a negative pressure system (3.3)
and used for transporting and/or treating patients with respiratory infectious diseases
4 4 General requirements for patient compartment
The patient compartment of the negative pressure ambulance shall meet the requirements of the type-B or
type-C ambulance in EN 1789:2020-12, 4.4.
5 5 Special requirements for patient compartment
5.1 5.1 Sealing and isolation requirements
The patient comp
...
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