prEN ISO 80601-2-61

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2024)

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
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 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE 1       See also 4.2 of the general standard. "The general standard" is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment ? Part 1: General requirements for basic safety and essential performance.
ISO 80601-2-61:2017 can also be applied to me equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2017 is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 2       Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
ISO 80601-2-61:2017 is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for those environments of use.
ISO 80601-2-61:2017 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO/DIS 80601-2-61:2024)

Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls (ISO/DIS 80601-2-61:2024)

ISO 80601-2-61:2017 s'applique à la sécurité de base et aux performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains, ci-après dénommés appareils em. Sont inclus tous les éléments de l'appareil nécessaires pour une utilisation normale, y compris le moniteur de l'oxymètre de pouls, le capteur de l'oxymètre de pouls et le câble de raccordement du capteur.
Ces exigences s'appliquent de la même manière aux oxymètres de pouls, y compris aux moniteurs d'oxymètre de pouls, aux capteurs d'oxymètre de pouls et aux câbles de raccordement du capteur, qui ont été remis en état.
L'utilisation prévue des oxymètres de pouls inclut notamment, sans toutefois s'y limiter, l'estimation de la saturation en oxygène de l'hémoglobine artérielle et de la fréquence du pouls chez des patients en établissement de soins professionnel ainsi que chez les patients dans l'environnement des soins à domicile et dans l'environnement des services médicaux d'urgence.
ISO 80601-2-61:2017 ne s'applique pas aux oxymètres de pouls destinés à être utilisés dans le cadre de recherches en laboratoire, de même qu'aux oxymètres nécessitant un échantillon de sang du patient.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils em ou uniquement aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils em et aux systèmes em, selon le cas.
Les dangers inhérents à la fonction physiologique prévue de l'appareil em ou des systèmes em dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11 et de 7.2.13 et 8.4.1 de la norme générale.
NOTE 1   Voir également 4.2 de la norme générale. La norme générale est l'IEC 60601-1:2005+AMD1:2012, Appareils électromédicaux ? Partie 1: Exigences générales pour la sécurité de base et les performances essentielles.
ISO 80601-2-61:2017 peut également être appliqué aux appareils em et à leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité.
ISO 80601-2-61:2017 ne s'applique pas aux oxymètres de pouls destinés uniquement à la surveillance de f?tus.
ISO 80601-2-61:2017 ne s'applique pas aux appareils distants ou esclaves (secondaires) qui affichent les valeurs de la SpO2 et qui sont situés à l'extérieur de l'environnement du patient.
NOTE 2   Il est attendu que les appareils em qui permettent une sélection entre des fonctions de diagnostic et de surveillance satisfassent aux exigences du document approprié lorsqu'ils sont configurés pour ladite fonction.
ISO 80601-2-61:2017 est applicable aux oxymètres de pouls destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur de l'environnement hospitalier ou d'un cabinet de médecin, telles que dans des ambulances ou dans les transports aériens. Des normes supplémentaires peuvent s'appliquer aux oxymètres de pouls pour ces environnements d'utilisation.
ISO 80601-2-61:2017 est une norme particulière des séries de normes de l'IEC 60601-1 et de l'ISO/IEC 80601.

Medicinska električna oprema - 2-61. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra (ISO/DIS 80601-2-61:2024)

General Information

• Status: Not Published
• Publication Date: 14-Jun-2026
• ICS: 11.040.55 - Diagnostic 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: 21-Nov-2024
• Completion Date: 21-Nov-2024
• Ref Project: oSIST prEN ISO 80601-2-61:2025 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2024)

Relations

• Revises: EN ISO 80601-2-61:2019 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02)
• Effective Date: 16-Feb-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2025
Medicinska električna oprema - 2-61. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pulznega oksimetra (ISO/DIS 80601-2-61:2024)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2024)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO/DIS
80601-2-61:2024)
Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls (ISO/DIS 80601-2-
61:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-61
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 80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
Particular requirements for basic 2024-11-18
safety and essential performance of
Voting terminates on:
2025-02-10
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
ICS: 11.040.10; 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
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 80601-2-61:2024(en)
DRAFT
ISO/DIS 80601-2-61:2024(en)
International
Standard
ISO/DIS 80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
ICS: 11.040.10; 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
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
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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
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-61:2024(en)
ii
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
1 Contents Page
2 201.1 Scope, object, and related standards . 1
3 201.2 Normative references . 3
4 201.3 Terms and definitions . 4
5 201.4 General requirements .18
6 201.5 General requirements for testing of ME equipment .19
7 201.6 Classification of ME equipment and ME systems .19
8 201.7 ME equipment identification, marking and documents .19
9 201.8 Protection against electrical hazards from ME equipment .24
10 201.9 Protection against mechanical hazards of ME equipment and ME systems .24
11 201.10 Protection against unwanted and excessive radiation hazards .24
12 201.11 Protection against excessive temperatures and other hazards .24
13 201.12 Accuracy of controls and instruments and protection against hazardous outputs .26
14 201.13 Hazardous situations and fault conditions for ME equipment .40
15 201.14 Programmable electrical medical systems (PEMS).40
16 201.15 Construction of ME equipment .41
17 201.16 ME systems .42
18 201.17 Electromagnetic compatibility of ME equipment and ME systems .43
19 201.101 Pulse oximeter probes and probe cable extenders .43
20 201.102 Saturation pulse information signal .44
21 201.103 Functional connection .44
22 202 Electromagnetic disturbances – Requirements and tests .44
23 202.4.3.1 Configurations .44
24 202.5.2.2.1 Requirements applicable to all ME equipment and ME systems .45
25 202.8.1.101 Additional general requirements .45
26 202.8.2 Patient physiological simulation .45
27 206 Usability .46
28 208 General requirements, tests and guidance for alarm systems in medical
29 electrical equipment and medical electrical systems .46
30 208.6.1.2.101 Additional requirements for alarm condition priority .46
31 208.6.5.4.101 Additional requirements for default alarm preset .46
32 208.6.8.5.101 Additional requirements for alarm signal inactivation states,
33 indication and access .47
34 211 Requirements for medical electrical equipment and medical electrical
35 systems used in the home healthcare environment .47
iii © ISO 2024 – All rights reserved

ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
36 212 Requirements for medical electrical equipment and medical electrical

37 systems used in the emergency medical services environment. 47
38 Annex C (informative) Guide to marking and labelling requirements for
39 ME equipment and ME systems . 48
40 Annex D (informative) Symbols on marking . 52
41 Annex AA (informative) Particular guidance and rationale . 53
42 Annex BB (informative) Skin temperature at the pulse oximeter probe . 75
43 Annex CC (informative) Determination of accuracy . 79
44 Annex DD (informative) Calibration standards . 89
45 Annex EE (normative) Method for controlled desaturation studies for evaluating and
46 documenting SpO2 accuracy in human participants . 90
47 Annex FF (informative) Simulators, calibrators, and functional testers for
48 pulse oximeter equipment . 97
49 Annex GG (informative) Concepts of ME equipment response time . 106
50 Annex HH (normative) Data interface requirements . 110
51 Annex II (informative) Clinical context and rationales . 116
52 Annex JJ (informative) Using a functional tester to assess pulse oximeter equipment
53 conditions of signal inadequacy over a range of transmitted light and optical
54 modulation . 117
55 Annex KK (informative) Using a transfer standard in pulse oximeter equipment
56 development . 121
57 Annex LL (informative) Reference to the IMDRF essential principles and
58 labelling guidances . 126
60 Figure 201.101 — Example finger pulse oximeter probe locations and orientation . 22
61 Figure 201.102 — Dorsal distal phalanx location . 34
62 Figure AA.1 — Example graph of the subject mean biases versus ITA . 58
63 Figure AA.2 — Probability of obtaining an observed A for fingerclip vs reference
rms
64 CO-oximeter less than or equal to 3,0, as a function of the true A , by sample size . 61
rms
65 Figure AA.3 — Comparison of sample size for two ranges of SaO2 to determine
66 the effects on sample size . 62
67 Figure CC.1 — Synthesized calibration data (base case) . 80
68 Figure CC.2 — Constant offset has been added to base case. 81
69 Figure CC.3 — Tilt has been added to base case . 82
70 Figure CC.4 — Graphical representation for the definition of local bias
71 (Test pulse oximeter probe SpO as a function of reference S ) . 83
R
72 Figure CC.5 — Graphical representation for the definition of local bias and mean bias
73 (Test probe SpO as a function of reference S ) . 84
R
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
74 Figure EE.1 — Example of desaturation-time profile . 93

75 Figure FF.1 — Sample calibration curve for pulse oximeter equipment . 99
76 Figure FF.2 — Interface of a functional tester that uses a photodiode and LED
77 to interact with a pulse oximeter probe . 101
78 Figure FF.3 — Interface of a functional tester that uses a dye mixture . 102
79 Figure FF.4 — Interface of a functional tester that uses a liquid crystal modulator . 102
80 Figure FF.5 — Absorbency of blue bandage material (measured in reflection) used in a
81 special test pulse oximeter probe with great patient-to-patient variability
82 of calibration . 104
83 Figure FF.6 — Calibration of high-variability pulse oximeter probe
84 in a controlled desaturation study on five test participa
...