prEN ISO 26782

• Abstract:

  ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg.; ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.

• Status: Not Published
• Publication Date: 02-Apr-2028
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 08-Oct-2026
• Completion Date: 08-Oct-2026
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 Amd 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: oSIST prEN ISO 26782:2026 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO/DIS 26782:2026)

• Referred By: EN ISO 14119:2025 - Safety of machinery - Interlocking devices associated with guards - Principles for design and selection (ISO 14119:2024)
• Effective Date: 28-Jan-2026
• Referred By: EN ISO 19085-15:2025 - Woodworking machines - Safety - Part 15: Presses (ISO 19085-15:2025)
• Effective Date: 28-Jan-2026
• Referred By: EN ISO/ASTM 52938-1:2025 - Additive manufacturing of metals - Environment, health and safety - Part 1: Safety requirements for PBF-LB machines (ISO/ASTM 52938-1:2025)
• Effective Date: 28-Jan-2026
• Revises: EN ISO 26782:2009/AC:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)
• Effective Date: 04-Sep-2024
• Revises: EN ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
• Effective Date: 04-Sep-2024

prEN ISO 26782 is a CEN draft standard for anaesthetic and respiratory equipment. It specifies requirements for spirometers that measure timed forced expired volumes in humans weighing more than 10 kg, whether the spirometer is a stand-alone device or part of an integrated lung function device.

The document is written for spirometer manufacturers, test laboratories, and healthcare users who need a common way to judge safety, marking, processing, and measuring performance. It is built around defined test profiles and objective checks so that the same device can be assessed the same way in design, verification, and regulatory work.

What does prEN ISO 26782 specify?

prEN ISO 26782 specifies the scope, safety, performance, construction, processing, and biocompatibility requirements for spirometers that measure timed forced expired volumes. It applies to devices used for pulmonary function assessment in humans weighing more than 10 kg and excludes devices intended for continuous patient monitoring.

The document is organized into 10 clauses plus informative and normative annexes. Clauses 4 to 10 cover general requirements, marking and documents, measurement range, performance, construction, cleaning/disinfection/sterilization, and biocompatibility.

Annex	What it covers
Annex A	Particular guidance and rationale for the requirements
Annex B	Normative testing for accuracy, linearity, impedance, and test reporting
Annex C	Normative defined test profiles used for performance testing
Annex D	Reference to the IMDRF essential principles and labelling principles
Annex E	Alphabetized index of defined terms
Annex ZA	Relationship with Regulation (EU) 2017/745

What are the key requirements of prEN ISO 26782?

prEN ISO 26782 focuses on whether the spirometer measures forced expired volume correctly, presents it clearly, and can be cleaned, checked, and used safely in practice. The most important requirements are in Clauses 4 to 10 and Annexes B and C.

• Electrical safety and mechanical safety - Clause 4 requires electrically powered spirometers to meet IEC 60601-1 with its amendments, and it applies IEC 60601-1 Clause 9 for mechanical safety. In practice, the device must already satisfy the basic medical electrical safety framework before its spirometry-specific requirements are considered.

• Manufacturer information and markings - Clause 5 requires the information supplied by the manufacturer to follow ISO 20417, and the scale or display must be in litres with display increments that stay within the stated measurement display limits. This matters because users need a readable and unambiguous display and instructions that match the device’s actual use.

• Instructions and technical description - Clause 5 also requires instructions for use to describe markings, warn about effects such as coughing and environmental extremes, and explain reassembly and filter use where relevant. The technical description must include accuracy limits, the method used to determine time zero, and the highest expiratory impedance, so buyers and service teams can verify suitability.

• Measurement range - Clause 6 requires a measurement range from zero to at least 8 l when referenced to BTPS conditions. That gives a clear capacity target for the device across the forced-expiration volumes expected in clinical spirometry.

• Performance requirements - Clause 7 sets the core measurement performance: accuracy, recording time, graphical display aspect ratios, FEV and FVC-related timing, linearly acceptable response, repeatability, and expiratory impedance. Annex B provides the test method, and Annex C provides the defined profiles used to challenge the spirometer across different start and finish shapes.

• Start and end of forced exhalation - Clause 7 requires the spirometer to indicate an acceptable start of forced exhalation and a satisfactory end-phase when the volume-time curve meets the stated criteria. In practice, this supports reliable identification of FEV and FVC results rather than just recording a trace.

• Construction, calibration, and reassembly - Clause 8 requires dropped hand-held components to survive testing, provides for calibration checking with a 3 l syringe of stated accuracy, and requires user-intended dismantling and reassembly to leave the device still conforming to Clause 7. This is important for portable devices and for systems that are cleaned or serviced in parts.

• Cleaning, disinfection, sterilization, and biocompatibility - Clauses 9 and 10 distinguish between single patient multiple use and multiple patient multiple use. They require processing instructions, validation, and material evaluation for patient-contacting parts and gas pathways, including restrictions on natural rubber latex and evaluation under ISO 10993-1 and ISO 18562-1.

What terms does prEN ISO 26782 define?

prEN ISO 26782 defines the terms used to describe the device, its outputs, and its use conditions. These definitions matter because they anchor the performance tests and the labeling and processing requirements.

• Body temperature and pressure saturated (BTPS) - Air volumes expressed at body temperature, ambient pressure, and saturated with water vapour.
• Forced expiratory volume (FEV) - The expiratory volume a patient produces under forced conditions.
• Forced vital capacity (FVC) - The maximal volume exhaled with a continuous maximum forced expiratory effort after maximal inspiration.
• Gas pathway - The interior surfaces over which respiratory gases or liquids pass.
• Expected lifetime - The manufacturer-defined period during which the product is expected to maintain basic safety and essential performance.
• Time zero - The point on the time axis determined by back extrapolation from the peak expiratory flow point.
• Single patient multiple use - A product intended to be reused on one patient for multiple uses.
• Multiple patient multiple use - A product intended to be reused on multiple patients for multiple uses.

Who uses prEN ISO 26782?

prEN ISO 26782 is used by spirometer manufacturers, accessory makers, and test laboratories to design, verify, and document product performance. It is also relevant to hospitals, clinics, and other responsible organizations that install, use, clean, disinfect, and maintain the device.

The standard supports quality and regulatory teams that need evidence on safety, marking, processing, biocompatibility, and measurement performance. It is also relevant to clinicians and service personnel who rely on consistent spirometry results for pulmonary function assessment.

What changed in prEN ISO 26782 from the previous edition?

The foreword states that this edition updates the previous ISO 26782 with several changes:

• normative references were updated;
• editorial changes were made to align with the latest ISO directives;
• test profile C8 was deleted from Table C.1 because it was unachievable;
• a new requirement was added to conform to ISO 20417:2026, with some overlapping requirements removed; and
• Annex D on environmental aspects was removed.

Which standards are used with prEN ISO 26782?

Clause 2 names the normative references that are needed to apply the standard:

• ISO 10993-1:2025 - biocompatibility evaluation of patient-contacting materials within a risk management process.
• ISO 14937:2009 - sterilization process characterization, validation, and routine control.
• ISO 17664-1:2021 - processing information for critical and semi-critical medical devices, used for gas pathways that need cleaning, disinfection, or sterilization.
• ISO 17664-2:2021 - processing information for non-critical medical devices, used for surface cleaning and disinfection instructions.
• ISO 18562-1:2024 - biocompatibility evaluation of breathing gas pathways.
• ISO 20417:2026 - manufacturer-supplied information for medical devices.
• IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020 - general safety and essential performance requirements for medical electrical equipment.

What does the prEN ISO 26782 document contain?

The document contains clause-based requirements and two normative test annexes that support verification. Annex B describes the apparatus, environmental conditions, procedure, calculations, and reporting needed to test accuracy, repeatability, linearity, and expiratory impedance.

Annex C provides mathematically defined test profiles with different volumes, time constants, start shapes, and end shapes. These profiles are used to check how the spirometer handles realistic forced exhalation traces and whether it calculates timed volumes correctly.

The document also includes figures and tables that explain time zero determination, profile shape, and the test set used in Annex B. Annex D and Annex ZA connect the document to IMDRF principles and to Regulation (EU) 2017/745 for European use.

SLOVENSKI STANDARD
01-december-2026
Anestezijska in dihalna oprema - Merilniki pretoka zraka (spirometri) za merjenje
pospešenega volumna izdiha pri ljudeh (ISO/DIS 26782:2026)
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of
time forced expired volumes in humans (ISO/DIS 26782:2026)
Anästhesie und Beatmungsgeräte - Spirometer zur Messung des zeitbezogenen
forcierten Exspirationsvolumens beim Menschen (ISO/DIS 26782:2026)
Matériel d'anesthésie et de réanimation respiratoire - Spiromètres destinés au mesurage
des volumes expiratoires forcés chronométrés chez les humains (ISO/DIS 26782:2026)
Ta slovenski standard je istoveten z: prEN ISO 26782
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 26782
ISO/TC 121/SC 3
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Spirometers intended
Voting begins on:
for the measurement of time forced
2026-10-05
expired volumes in humans
Voting terminates on:
2026-12-28
Matériel d'anesthésie et de réanimation respiratoire —
Spiromètres destinés au mesurage des volumes expiratoires forcés
chronométrés chez les humains
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 26782:2026(en)
DRAFT
ISO/DIS 26782:2026(en)
International
Standard
ISO/DIS 26782
ISO/TC 121/SC 3
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Spirometers intended
Voting begins on:
for the measurement of time forced
expired volumes in humans
Voting terminates on:
Matériel d'anesthésie et de réanimation respiratoire —
Spiromètres destinés au mesurage des volumes expiratoires forcés
chronométrés chez les humains
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 26782:2026(en)
ii
ISO/DIS 26782:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope (see Clause A.2) . 1
2 Normative references . 1
3 Terms and definitions (see Clause A.3) . 2
4 General requirements .12
4.1 Electrical safety . 12
4.2 Mechanical safety . 12
5 Identification, marking and documents .12
5.1 Information to be supplied by the manufacturer . 12
5.2 Marking of the scale or display . 12
5.3 Legibility of markings . 13
5.4 Durability of markings . 13
5.5 Marking of the spirometer or its packaging . 13
5.6 Instructions for use .14
5.7 Technical description.14
6 Measurement range . 14
7 Performance requirements (see Clause A.4) . 14
7.1 Accuracy .14
7.2 Recording time . 15
7.3 Graphical display aspect ratios . 15
7.4 Volume recording . 15
7.5 Start of forced exhalation (see A.4.1). 15
7.6 End of forced exhalation (see A.4.2) . 15
7.7 Linearity . 15
7.8 Repeatability .16
7.9 Expiratory impedance .16
8 Constructional requirements .16
8.1 Effects of dropping components of a hand-held spirometer or accessory .16
8.2 Calibration .16
8.3 Dismantling and re-assembly.16
9 Cleaning, disinfection and sterilization . 17
9.1 Single patient multiple use . .17
9.2 Multiple patient multiple use .17
10 Biocompatibility .18
10.1 Patient contacting .18
10.2 Gas pathway contacting .18
Annex A (informative) Particular guidance and rationale . 19
Annex B (normative) Testing accuracy, linearity and impedance .23
Annex C (normative) Defined test profiles (see Clause A.6).27
Annex D (informative) Reference to the essential principles .30
Annex E (informative) Alphabetized index of defined terms used in this document .32
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .34
Bibliography .40

iii
ISO/DIS 26782:2026(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 26782 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
The main changes are as follows:
— Normative references updated;
— Editorial changes made to conform with the latest ISO directives;
— Test profile C8 deleted in Table C.1 as it was unachievable and text amended to reflect that deletion;
— New requirement to conform with ISO 20417:2026 and removal of those requirements now covered by
this standard; and
— Annex D on Environmental aspects has been removed as it is no longer accepted.

iv
ISO/DIS 26782:2026(en)
Introduction
A spirometer is a medical device that records physiological lung ventilation volumes within the range of the
vital capacity.
The timed volumes that a patient is able to expel after a maximal inspiration give a reliable method of
assessing lung function. These spirometric assessments are used, for many purposes including but not
limited to:
— screening individuals at risk of lung disease;
— giving objective measures in the presence of lung disease;
— evaluating symptoms and pre-operative risk;
— recording the effect of therapeutic intervention; and
— evaluating pulmonary disability, public health and clinical trials.
The American Thoracic Society (ATS) and the European Respiratory Society (ERS) have been instrumental
in developing recommendations for the standardization of lung function testing, including guidelines for
[1][2]
spirometry . There is however no recognised international or national standard for spirometers with
reliance for accuracy, repeatability, etc. based on objective test methodology and on meeting defined
tolerances when tested with a carefully selected set of defined test profiles such as those published by the
ATS.
This document addresses this problem by developing a standard for a spirometer to give the clinician the
confidence that any spirometer used meets agreed standards of accuracy, repeatability, electrical safety, etc.
The minimum safety requirements specified in this document are considered to provide a practical degree
of safety in the operation of spirometers.
The requirements are followed by specifications for the relevant tests.
Annex A contains rationale and guidance giving some explanatory notes, where appropriate, about the more
important requirements is included in this document.

v
DRAFT International Standard ISO/DIS 26782:2026(en)
Anaesthetic and respiratory equipment — Spirometers
intended for the measurement of time forced expired
volumes in humans
1 Scope (see Clause A.2)
This document specifies requirements for spirometers intended for the assessment of pulmonary function
in humans weighing more than 10 kg.
This document applies to a spirometer that measures timed forced expired volumes, either as part of an
integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.
Devices intended for continuously monitoring patients are outside the scope of this document.
[3] [4]
NOTE This document has been prepared to address the relevant essential principles and labelling principles
of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
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 10993-1:2025, Biological evaluation of medical devices — Part 1: Requirements and general principles for
the evaluation of biological safety within a risk management process
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 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1:
Evaluation and testing within a risk management process
ISO 20417:2026, Medical devices — Information to be supplied by the manufacturer
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
IEC 60601-1:2005/AMD1: 2012, Amendment 1 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
IEC 60601-1:2005/AMD2: 2020, Amendment 2 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
ISO/DIS 26782:2026(en)
3 Terms and definitions (see Clause A.3)
For the purposes of this document the following terms and definitions apply.
Annex E contains an alphabetized index of defined terms.
3.1
accessory, noun
item intended specifically by its manufacturer (3.15) to be used together with one or more medical devices
(3.18) to specifically enable or assist those medical devices (3.18) to be used in accordance with their intended
use (3.13)
Note 1 to entry: An accessory (3.1) is typically a consumable or separate item for use with one or more medical devices
(3.18).
Note 2 to entry: Some authorities having jurisdiction consider an accessory (3.1) to be a medical device (3.18).
Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory (3.1).
Note 4 to entry: In general, spare parts are not considered accessories (3.1).
[5]
[SOURCE: IEC 60050-880, 880-08-04]
3.2
accompanying information, noun
DEPRECATED: accompanying documents
DEPRECATED: accompanying documentation
information supplied by the manufacturer (3.15) with or marked (3.16) on a medical device (3.18) or accessory
(3.1) for the user (3.30) or the responsible organization (3.23), particularly regarding safe use
Note 1 to entry: The accompanying information (3.2) is regarded as part of the medical device (3.18) or accessory (3.1).

ISO/DIS 26782:2026(en)
Note 2 to entry: The accompanying information (3.2) can consist of the label, marking (3.16), instructions for use (3.14),
technical description (3.27), information shown on the packaging or graphical user (3.30) interface (GUI), installation
manual, quick reference guide, etc. and can address the installation, use, processing (3.21), maintenance and disposal
of the medical device (3.18) or accessory (3.1).
Note 3 to entry: Accompanying information (3.2) is not necessarily a written or printed document but can involve
auditory, visual or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB stick, website).
Note 4 to entry: Medical devices and accessories (3.1) that can be used safely without accompanying information (3.2)
are exempted from having accompanying information (3.2) by some authorities having jurisdiction.
[5]
[SOURCE: IEC 60050-880, 880-10-01]
3.3
body temperature and pressure saturated, noun
BTPS, noun
body temperature (37 °C), at the ambient pressure and saturated with water vapour
3.4
clearly legible, noun
easily legible, noun
capable of being read by a person with normal vision
[5]
[SOURCE: IEC 60050-880, 880-20-02]
3.5
conformity, noun
DEPRECATED: conformance
DEPRECATED: compliance
fulfilment of a requirement
Note 1 to entry: In English the word “conformance (3.5)” is synonymous but deprecated. In French the word “compliance
(3.5)” is synonymous but deprecated.
[5]
[SOURCE: IEC 60050-880, 880-14-07]
3.6
expected lifetime, noun
expected service life, noun
period specified by the manufacturer (3.15) during which the product is expected to maintain basic safety
and essential performance
Note 1 to entry: Maintenance, repairs or upgrades (e.g. safety or security modifications) can be necessary during the
expected lifetime (3.6).
Note 2 to entry: Some products have an absolute expected lifetime (3.6) (e.g. 5 years) and some have an expected lifetime
(3.6) based on the number of uses or cycles (e.g. 15 uses) or duration of use, whereas other products (e.g. software)
have a relative expected lifetime (3.6) (e.g. the time between two major releases).
Note 3 to entry: The expected lifetime (3.6) can be related to:
— healthcare products whose performance, physical, chemical or functional properties can be altered or compromised
over a stated time interval;
— the period over which sterility is assured;
— in vitro diagnostic (IVD) reagents, calibrators and controls, when stored, transported and used in accordance with
conditions specified in the information supplied by the manufacturer (3.15); and
— measuring instruments or measuring systems after calibration.
Note 4 to entry: The expected lifetime (3.6) of an in vitro diagnostic (IVD) reagent or measuring system is normally
quantified in terms of:
— a time interval over which a measured property changes by a stated amount; or

ISO/DIS 26782:2026(en)
— the change of a property under specified conditions.
[5]
[SOURCE: IEC 60050-880, 880-17-07]
3.7
forced expiratory volume, noun
FEV, noun
expiratory volume of a patient (3.22) under forced conditions
3.8
forced expiratory volume after time t, noun
FEV , noun
t
, noun
FEV , noun
0,025
FEV , noun
FEV , noun
expiratory volume of a patient (3.22) under forced conditions at time t in seconds, measured from time zero
(3.28)
3.9
forced vital capacity, noun
FVC, noun
maximal volume of air exhaled with a continuous maximum forced expiratory effort from the point of
maximal inspiration
3.10
gas pathway
interior surfaces over which respiratory gases or liquids pass that can be inspired
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.
Note 1 to entry: The gas pathway (3.10) is bounded by the fluid ports through which gases or liquids enter the medical
device (3.18) or accessory (3.1). This can include the patient (3.22) interface or the interior surfaces of enclosures that
are in contact with gases or liquids that can be inspired.
Note 2 to entry: The gas pathway (3.10) can include some surfaces in the expiratory pathway.
Note 3 to entry: The fluids from a gas pathway (3.10) can be ingested.
[5]
[SOURCE: IEC 60050-880, 880-08-14]
3.11
hand-held, adj
intended to be supported by the hand once installed and placed into service

ISO/DIS 26782:2026(en)
Note 1 to entry: Accessories (3.1) or equipment parts can be hand-held (3.11).
[5]
[SOURCE: IEC 60050-880, 880-02-09]
3.12
inspection
conformity (3.5) evaluation by observation and judgement accompanied as appropriate by measurement,
testing or gauging
[5]
[SOURCE: IEC 60050-880, 880-14-14]
3.13
intended use, noun
intended purpose, noun
use for which a product or process is intended according to the specifications, instructions for use (3.14) and
other information supplied by the manufacturer (3.15)

ISO/DIS 26782:2026(en)
Note 1 to entry: The intended medical indication, patient (3.22) population, part of the body or type of tissue interacted
with, user (3.30) profile, use environment, and operating principle are typical elements of the intended use (3.13).
Note 2 to entry: Intended use (3.13) is different from normal use (3.20). Both include the concept of use as intended
by the manufacturer (3.15). However, intended use (3.13) focuses on the medical purpose whereas normal use (3.20)
incorporates not only the medical purpose, but maintenance, transport, processing (3.21) , etc. as well.
Note 3 to entry: Product includes service.
[5]
[SOURCE: IEC 60050-880, 880-20-06]
3.14
instructions for use
package insert, noun
portion of the accompanying information (3.2) that is:
— directed to the primary user (3.30); and
— essential for the safe and effective use of a medical device (3.18) or accessory (3.1)

ISO/DIS 26782:2026(en)
Note 1 to entry: A user (3.30) can be either a lay user (3.30) or healthcare professional user (3.30) with relevant
specialized training.
Note 2 to entry: Instructions for the professional processing (3.21) between uses of a medical device (3.18) or accessory
(3.1) can be included in the instructions for use (3.14).
Note 3 to entry: The instructions for use (3.14) , or portions thereof, can be located on the display of a medical device
(3.18) or accessory (3.1).
Note 4 to entry: medical devices (3.18) or accessories that can be used safely and effectively without instructions for use
(3.14) are exempted from having instructions for use (3.14) by some authorities having jurisdiction.
[5]
[SOURCE: IEC 60050-880, 880-10-06]
3.15
manufacturer, noun
organization with responsibility for design or manufacture of a product with the intention of making the
product available for use, under its name; whether such a product is designed or manufactured by that
organization itself or on its behalf by another organization
Note 1 to entry: This organization has ultimate legal responsibility for ensuring compliance with all applicable
policies for the product in the countries or jurisdictions where it is intended to be made available or sold, unless this
responsibility is specifically imposed on another organization by the authority having jurisdiction.
Note 2 to entry: The manufacturer’s responsibilities include meeting both pre-market requirements and post-market
requirements, such as adverse event reporting and notification of corrective actions.
Note 3 to entry: For a medical device (3.18) or accessory (3.1), “design or manufacture” can include specification
development, production, fabrication, assembly, processing (3.21), packaging, repackaging, labelling, relabelling,
sterilization, installation or remanufacturing of a medical device (3.18) or accessory (3.1) or putting a collection of
medical devices or accessories, and possibly other products, together for a medical purpose.

ISO/DIS 26782:2026(en)
Note 4 to entry: For a medical device (3.18) or accessory (3.1), any organization which assembles or adapts a medical
device (3.18) or accessory (3.1) that has already been supplied by another organization for an individual patient (3.22),
in accordance with the instructions for use (3.14), is not the manufacturer (3.15), provided the assembly or adaptation
does not change the intended use (3.13) of the medical device (3.18) or accessory (3.1)
Note 5 to entry: For a medical device (3.18) or accessory (3.1), any organization which changes the intended use (3.13) of
or modifies a medical device (3.18) or accessory (3.1) without acting on behalf of the original manufacturer (3.15) and
which makes it available for use under its own name, is considered the manufacturer (3.15) of the modified medical
device (3.18) or accessory (3.1).
Note 6 to entry: An authorized representative, distributor or importer who only adds their own address and contact
details to the product or the packaging, without covering or changing the existing information supplied by the
manufacturer (3.15), is not considered a manufacturer (3.15).
Note 7 to entry: To the extent that an accessory (3.1) is subject to the applicable policies of a medical device (3.18),
the organization responsible for the design or manufacture of that accessory (3.1) is considered to be a manufacturer
(3.15).
[5]
[SOURCE: IEC 60050-880, 880-12-14]
3.16
marking, noun
marked, noun
information, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to
a product
Note 1 to entry: The word “marked (3.16)” is used to designate the corresponding act.
Note 2 to entry: Marking (3.16) 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 (3.16).
[5]
[SOURCE: IEC 60050-880, 880-10-10]

ISO/DIS 26782:2026(en)
3.17
measurement range, noun
set of values of measurements for which the error of a measuring instrument is intended to lie within
specified limits
Note 1 to entry: There is guidance or rationale for this definition contained in A.3.1.
3.18
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material
or other similar or related article, intended by the manufacturer (3.15) to be used, alone or in combination,
for patients (3.22), for one or more of the specific medical purposes of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing information by means of in vitro examination of specimens derived from the patient (3.22),
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the patient (3.22), but which can be assisted in its intended function by such means
Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances,
— aids for persons with disabilities,
— devices incorporating animal or human tissues,
— devices for in-vitro fertilization or assisted reproductive technologies.
[5]
[SOURCE: IEC 60050-880, 880-08-24]
3.19
multiple patient multiple use
intended by the manufacturer (3.15) to be reused on multiple patients (3.22) for multiple uses
Note 1 to entry: A multiple patient multiple use (3.19) product typically requires processing (3.21) between patients
(3.22).
Note 2 to entry: A multiple patient multiple use (3.19) product can require processing (3.21) between uses on a single
patient (3.22).
[5]
[SOURCE: IEC 60050-880, 880-02-15]
3.20
normal use, noun
operation, including routine inspection (3.12) and adjustments by any user (3.30), in accordance with the
accompanying information (3.2) or, for those products provided without accompanying information (3.2),
with generally accepted practice
Note 1 to entry: Normal use (3.20) is different from intended use (3.13). While both include the concept of use as
intended by the manufacturer (3.15), intended use (3.13) focuses on the medical purpose whereas normal use (3.20)
incorporates not only the medical purpose, but maintenance, transport, processing (3.21), etc. as well.
Note 2 to entry: Use error can occur in normal use (3.20).

ISO/DIS 26782:2026(en)
Note 3 to entry: Healthcare products that can be used safely without accompanying information (3.2) are exempted
from having accompanying information (3.2) by some authorities having jurisdiction.
Note 4 to entry: Operating in an abnormal external situation is not normal use (3.20).
[5]
[SOURCE: IEC 60050-880, 880-20-07]
3.21
processing, noun
processes to prepare a new or used healthcare product for its intended use (3.13)
Note 1 to entry: Processing (3.21) includes cleaning, disinfection and sterilization, as appropriate.
[5]
[SOURCE: IEC 60050-880, 880-03-03]
3.22
patient, noun
living being receiving healthcare services
Note 1 to entry: Living being means person or animal.
Note 2 to entry: Healthcare services include diagnostic, therapeutic, monitoring, surgical or dental procedures and
can be delivered in the home healthcare environment, professional healthcare environment, EMS environment or a
special environment.
Note 3 to entry: A patient (3.22) can be a user (3.30).
Note 4 to entry: Safety limit values can be different for different patients (3.22), especially for animal patients (3.22).
[5]
[SOURCE: IEC 60050-880, 880-12-16]
3.23
responsible organization, noun
organization accountable for the installation, use, processing (3.21), maintenance, decommissioning or
disposal of a medical device (3.18) or accessory (3.1) and their detachable parts
Note 1 to entry: The responsible organization (3.23) includes those individuals performing the activities for the
responsible organization (3.23) including the preparation of the infrastructure needed to support the installation.
Note 2 to entry: The responsible organization (3.23) can be, for example, a hospital, an individual healthcare professional
provider or a lay person. In home use applications, the patient (3.22), user (3.30) and responsible organization (3.23)
can be one and the same person.
Note 3 to entry: Education and training are included in “use”.
[5]
[SOURCE: IEC 60050-880, 880-12-18]
3.24
single patient multiple use, adj
intended by the manufacturer (3.15) to be reused on an individual patient (3.22) for multiple uses
Note 1 to entry: A single patient multiple use (3.24) product can require processing (3.21) between uses.
Note 2 to entry: For an implantable medical device (3.18) , the duration from implanting to explanting is considered
single use (3.25) and not single patient multiple use (3.24).
[5]
[SOURCE: IEC 60050-880, 880-02-20]

ISO/DIS 26782:2026(en)
3.25
single use, adj
do not reuse, adj
use only once, adj
intended by the manufacturer (3.15) to be used on an individual patient (3.22) or an individual specimen
during a single procedure and then disposed of
Note 1 to entry: A single use (3.25) product is not intended by its manufacturer (3.15) to be further processed and used
again.
Note 2 to entry: For an implantable medical device (3.18), the duration from implanting to explanting is considered
single use (3.25) and not single patient multiple use (3.24).
[5]
[SOURCE: IEC 60050-880, 880-02-21]
3.26
spirometer, noun
medical device (3.18) for recording forced expiratory volume (3.7) over a period of time
3.27
technical description
portion of the accompanying information (3.2) that is:
— directed to the responsible organization (3.23) and service personnel; and
— essential for: installation, preparation for the first use and safe use, maintenance or repair, processing
(3.21), transport or storage for the expected lifetime (3.6), and decommissioning or disposal
[5]
[SOURCE: IEC 60050-880, 880-10-16]

ISO/DIS 26782:2026(en)
3.28
time zero, noun
point of intersection on the time axis of a line drawn on the volume time trace through the point of peak
expiratory flow (PEF) with a slope equal to peak expiratory flow
Note 1 to entry: There is guidance or rationale for this definition contained in A.3.2.
3.29
tool, noun
extra-corporeal item that can be used to secure or release fasteners or to make adjustments
Note 1 to entry: Coins and keys can be considered tools (3.29).
[5]
[SOURCE: IEC 60050-880, 880-09-15]
3.30
user, noun
person operating, handling or interacting with the product
Note 1 to entry: There can be more than one user (3.30) of a product.
Note 2 to entry: Common users (3.30) include healthcare professional providers, patients (3.22), lay caregivers,
processors and service personnel.
[5]
[SOURCE: IEC 60050-880, 880-12-21]
4 General requirements
4.1 Electrical safety
Spirometers that utilize electrical power shall meet the applicable requirements in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1: 2012 and IEC 60601-1:2005/AMD2: 2020, in addition to the requirements in this
document.
Check conformity by application of the tests of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1: 2012 and
IEC 60601-1:2005/AMD2: 2020.
4.2 Mechanical safety
Spirometers shall comply with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1: 2012 and IEC 60601-1:2005/
AMD2: 2020, Clause 9.
Check conformity by inspection.
5 Identification, marking and documents
5.1 Information to be supplied by the manufacturer
a) The information to be supplied by the manufacturer shall be in accordance with ISO 20417:2026.
b) Check conformity by application of ISO 20417:2026.
5.2 Marking of the scale or display
The scale or display of a spirometer shall be marked as follows.
a) The scale or display shall be in units of litres.
b) The numbering on a scale or digital display shall not exceed the measurement range.

ISO/DIS 26782:2026(en)
c) For spirometers with volume traces as the primary output, the increment between any two adjacent
graduation lines shall represent a difference in volume no greater than 0,1 l and the numbering on a
scale shall appear at intervals no greater than 1,0 l.
d) For spirometers with a digital display the incremental step shall be no greater than 0,01 l.
Check conformity by inspection.
5.3 Legibility of markings
The markings required by 5.2 and 5.5 shall be clearly legible under the following conditions:
a) For warning statements, instructive statements, safety signs and drawings on the outside of the
spirometer, from the intended position of the user performing the related function.
b) For markings on the inside of the spirometer or spirometer parts, from the intended position of the user
performing the related function.
c) Check conformity for a clearly legible marking by the following test.
1) Position the spirometer or its part so that the viewpoint is the intended position of the user; or the
viewpoint is at any point within the base of a cone subtended by an angle of 30° to the axis normal
to the centre of the plane of the marking and at a distance of 1 m.
2) Ensure that the ambient illuminance is the least favourable level in the range of 100 lx to 1 500 lx.
3) Ensure that the observer has a visual acuity of 0 on the log minimum angle of resolution (log MAR)
scale or 6/6 (20/20), corrected if necessary.
4) The observer correctly reads the marking from the viewpoint.
5.4 Durability of markings
a) The markings required by 5.2 and 5.5 shall be:
1) removable only with a tool or by appreciable force: and
2) sufficiently durable to remain clearly legible during the expected service life of the spirometer.
i) In considering the durability of the markings, the effect of normal use shall be taken into
account.
NOTE Recordings or paper output chards are not considered markings.
b) Check conformity by inspection and the following tests.
1) After all the other tests of this document have been performed:
i) rub markings by hand, without undue pressure, first for 15 s with a cloth rag soaked with
distilled water, then for 15 s with a cloth rag soaked with methylated spirits and then for 15 s
with a cloth rag soaked with isopropyl alcohol;
ii) test the legibility of markings to the requirements of 5.3; and
iii) ensure that adhesive labels have not worked loose or become curled at the edges.
5.5 Marking of the spirometer or its packaging
a) The spirometer and, where physically possible, its accessories shall be marked with a symbol showing
the direction of flow for any user-detachable components that are flow-direction sensitive unless
designed in such a way as to prevent incorrect use or assembly.
b) Check conformity by inspection.

ISO/DIS 26782:2026(en)
5.6 Instructions for use
The instructions for use shall include the following:
a) a description of all markings on the spirometer;
EXAMPLE Figures, symbols, warning statements, abbreviations and indicator lights.
b) a statement that the performance of the spirometer can be affected by the patient spitting or coughing
into the spirometer during expiration or by extremes of temperature, humidity and altitude if applicable;
c) if installation of the spirometer or its parts is required, a reference to where the installation instructions
are to be found (e.g. the technical description);
d) the correct method of re-assembly, if the spirometer is intended to be dismantled by the user;
e) details of the spirometer checks that the user should consider if unusual readings are obtained;
f) details of any breathing system filter recommended.
Check conformity by inspection.
5.7 Technical description
a) The technical description shall i
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