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)

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 80601-2-61:2017, korrigierte Fassung 2018-02)

Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2017, Version corrigée 2018-02)

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 80601-2-61:2017, popravljena verzija 2018-02)

Standard SIST EN-ISO 80601-2-61 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME PULZNIH OKSIMETROV, namenjenih za uporabo pri ljudeh (v nadaljevanju ELEKTROMEDICINSKA OPREMA). To zajema kateri koli del, potreben za OBIČAJNO UPORABO, vključno z monitorjem PULZNEGA OKSIMETRA, SONDO PULZNEGA OKSIMETRA in PODALJŠKOM KABLA SONDE. Te zahteve veljajo tudi za OPREMO PULZNIH OKSIMETROV, vključno z MONITORJI PULZNIH OKSIMETROV, SONDAMI PULZNIH OKSIMETROV in PODALJŠKI KABLOV SOND, ki so bili PONOVNO OBDELANI. Predvidena uporaba opreme pulznih oksimetrov med drugim zajema oceno nasičenosti arterijske krvi s kisikom in hemoglobinom ter oceno pulza pri BOLNIKIH v zdravstvenih ustanovah, pa tudi pri BOLNIKIH v OKOLJU DOMAČE OSKRBE in v OKOLJU NUJNIH ZDRAVSTVENIH STORITEV. Ta dokument se ne uporablja za OPREMO PULZNIH OKSIMETROV, namenjeno za uporabo v laboratorijskih raziskavah, niti za oksimetre, ki zahtevajo vzorec krvi BOLNIKA. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME ali SISTEMOV, ki spadajo na področje tega dokumenta, razen v točkah 201.11 ter v 7.2.13 in 8.4.1 splošnega standarda. Ta dokument se lahko uporablja tudi za ELEKTROMEDICINSKO OPREMO in njeno DODATNO OPREMO, ki se uporablja za lajšanje bolezni, poškodb ali invalidnosti. Ta dokument se ne uporablja za OPREMO PULZNIH OKSIMETROV, namenjeno samo za uporabo pri plodu. Ta dokument se ne uporablja za oddaljeno ali dodatno (sekundarno) opremo, ki prikazuje vrednosti SpO2 zunaj OKOLJA BOLNIKA. Ta dokument se ne uporablja za OPREMO PULZNIH OKSIMETROV, ki je namenjena za uporabo v izrednih ali nenadzorovanih vremenskih razmerah zunaj bolnišnic ali zdravniških ordinacij, npr. v reševalnih vozilih ali zračnem prometu. Za OPREMO PULZNIH OKSIMETROV v tovrstnih okoljih se lahko uporabljajo dodatni standardi. Ta dokument je STANDARD iz skupin standardov IEC 60601-1 in ISO/IEC 80601.

General Information

Status
Published
Publication Date
29-Jan-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
30-Jan-2019
Completion Date
30-Jan-2019

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SLOVENSKI STANDARD
SIST EN ISO 80601-2-61:2019
01-april-2019
1DGRPHãþD
SIST EN ISO 80601-2-61:2011
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLSXO]QHJDRNVLPHWUD ,62SRSUDYOMHQDYHU]LMD


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)

Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO
80601-2-61:2017)

Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base

et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2017,

Version corrigée 2018-02)
Ta slovenski standard je istoveten z: EN ISO 80601-2-61:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-61:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-61:2019
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SIST EN ISO 80601-2-61:2019
EN ISO 80601-2-61
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.55 Supersedes EN ISO 80601-2-61:2011
English Version
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)

Appareils électromédicaux - Partie 2-61: Exigences Medizinische elektrische Geräte - Teil 2-61: Besondere

particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der

performances essentielles pour les oxymètres de pouls wesentlichen Leistungsmerkmale von

(ISO 80601-2-61:2017, Version corrigée 2018-02) Pulsoximetriegeräten (ISO 80601-2-61:2017)

This European Standard was approved by CEN on 13 December 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 06 March 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-61:2019 E

worldwide for CEN national Members.
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SIST EN ISO 80601-2-61:2019
EN ISO 80601-2-61:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 80601-2-61:2019
EN ISO 80601-2-61:2019 (E)
European foreword

This document (EN ISO 80601-2-61:2019) has been prepared by Technical Committee ISO/TC 121

"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215

“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by July 2019, and conflicting national standards shall be

withdrawn at the latest by January 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 80601-2-61:2011.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 80601-2-61:2017, Corrected version 2018-02 has been approved by CEN as

EN ISO 80601-2-61:2019 without any modification.
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SIST EN ISO 80601-2-61:2019
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SIST EN ISO 80601-2-61:2019
INTERNATIONAL ISO
STANDARD 80601-2-61
Second edition
2017-12
Corrected version
2018-02
Medical electrical equipment —
Part 2-61:
Particular requirements for basic
safety and essential performance of
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
Reference number
ISO 80601-2-61:2017(E)
ISO 2017
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
Published in Switzerland
© ISO 2017 – All rights reserved
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)
Contents Page

Foreword ......................................................................................................................................................................................... v

Introduction .................................................................................................................................................................................. vi

201. 1 Scope, object and related standards ........................................................................................................................ 1

201. 2 Normative references ................................................................................................................................................... 3

201. 3 Terms and definitions .................................................................................................................................................. 4

201. 4 General requirements .................................................................................................................................................. 9

201. 5 General requirements for testing of ME EQUIPMENT ........................................................................................... 10

201. 6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................................................................... 10

201. 7 ME EQUIPMENT identification, marking and documents .................................................................................... 11

201. 8 Protection against electrical HAZARDS from ME EQUIPMENT ............................................................................... 15

201. 9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS ................................................... 15

201. 10 Protection against unwanted and excessive radiation HAZARDS ................................................................... 15

201. 11 Protection against excessive temperatures and other HAZARDS ................................................................... 15

201. 12 Accuracy of controls and instruments and protection against hazardous outputs ............................... 17

201. 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ......................................................................... 21

201. 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................................................................... 21

201. 15 Construction of ME EQUIPMENT ................................................................................................................................... 21

201. 16 ME SYSTEMS ...................................................................................................................................................................... 23

201. 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ................................................................... 23

201. 101 * PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS .................................................................................. 23

201. 102 Saturation pulse INFORMATION SIGNAL ............................................................................................................. 23

201. 103 FUNCTIONAL CONNECTION ....................................................................................................................................... 24

202 Electromagnetic disturbances – Requirements and tests .............................................................................. 24

206 Usability ......................................................................................................................................................................... 25

208 General requirements, tests and guidance for alarm systems in medical electrical equipment

and medical electrical systems ............................................................................................................................... 26

211 Requirements for medical electrical equipment and medical electrical systems used in the

home healthcare environment ............................................................................................................................... 26

212 Requirements for medical electrical equipment and medical electrical systems used in the

emergency medical services environment ......................................................................................................... 27

Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS ..... 28

Annex D (informative) Symbols on marking .................................................................................................................... 31

Annex AA (informative) Particular guidance and rationale ........................................................................................ 32

Annex BB (informative) Skin temperature at the PULSE OXIMETER PROBE ................................................................... 40

ANNEX CC (informative) Determination of ACCURACY ........................................................................................................ 44

Annex DD (informative) Calibration standards............................................................................................................... 53

Annex EE (informative) Guideline for evaluating and documenting SpO ACCURACY in human subjects ....... 54

Annex FF (informative) Simulators, calibrators and FUNCTIONAL TESTERS for PULSE OXIMETER EQUIPMENT ......... 61

© ISO 2017 – All rights reserved iii
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)

Annex GG (informative) Concepts of ME EQUIPMENT response time ............................................................................. 70

Annex HH (normative) Data interface requirements ..................................................................................................... 74

Annex II (informative) Reference to the ESSENTIAL PRINCIPLES ....................................................................................... 78

Annex JJ (informative) Terminology — alphabetized index of defined terms ....................................................... 82

Bibliography ................................................................................................................................................................................. 87

iv © ISO 2017 – All rights reserved
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non‐governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in

the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO

documents should be noted. This document was drafted in accordance with the editorial rules of the

ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights

identified during the development of the document will be in the Introduction and/or on the ISO list of patent

declarations received (see www.iso.org/patents).

trade name used in this document is information given for the convenience of users and does not constitute

Any
an endorsement.

For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.

This document was prepared jointly by ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3,

Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical equipment in medical

practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting to the national bodies of

both ISO and IEC.

This second edition of ISO 80601‐2‐61 cancels and replaces the first edition(ISO 80601‐2‐61:2011), which has

been technically revised. It includes an alignment with Amendment 1 of both the third edition of IEC 60601‐1 and

the second edition of IEC 60601‐1‐8, as well as the fourth edition of IEC 60601‐1‐2, the third edition of IEC 60601‐

1‐6, the second edition of IEC 60601‐1‐11 and IEC 60601‐1‐12.
The most significant changes are the following modifications:

– updated rationale (Annex AA) and references related to advances in the understanding of hypoxaemia,

electronic health records and ALARM SYSTEMS;
– ingress protection changed from IPX1 to IPX2;
and the following additions:
– Clause 211, requirements for use in the HOME HEALTHCARE ENVIRONMENT;

– Clause 212, requirements for use in the emergency medical services (EMS) environment;

– Annex HH, Data interface requirements.

This corrected version of ISO 80601‐2‐61:2017 incorporates the following correction:

– headers have been corrected.

A list of all the parts of the ISO/IEC 80601 series is available on the ISO website.

© ISO 2017 – All rights reserved v
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)
Introduction

The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice in

many areas of medicine. This document covers BASIC SAFETY and ESSENTIAL PERFORMANCE requirements achievable

within the limits of existing technology.

The committees recognized the need to revise the first edition of this document because of the publication of the

first edition of IEC 60601‐1‐12, as well as the fourth edition of IEC 60601‐1‐2, the second edition of IEC 60601‐1‐

11 and the first Amendments to both the third edition of IEC 60601‐1, the third edition of IEC 60601‐1‐6 and the

second edition of IEC 60601‐1‐8.

Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into the

reasoning of the committees that led to a requirement and identifying the HAZARDS that the requirement addresses.

Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the interface

between a PULSE OXIMETER PROBE and a PATIENT'S tissue.

Annex CC discusses both the formulae used to evaluate the SpO ACCURACY of PULSE OXIMETER EQUIPMENT

measurements, and the names that are assigned to those formulae.

Annex DD presents guidance on when in vitro blood calibration of PULSE OXIMETER EQUIPMENT is needed.

Annex EE presents a guideline for a CONTROLLED DESATURATION STUDY for the calibration of PULSE OXIMETER EQUIPMENT.

Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry.

Annex GG describes concepts of PULSE OXIMETER EQUIPMENT response time.
Annex HH describes data interface requirements.

Annex II contains Reference to the ESSENTIAL PRINCIPLES formerly found in Annex HH.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type;

normative text of tables is also in a smaller type;

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.

In referring to the structure of this document, the term

– “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions (e.g.

Clause 201 includes subclauses 201.7.1, 201.7.2) and

– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 7.2 and 201.7.2.1 are all subclauses of

Clause 201.7).

The general standard is IEC 60601‐1:2005 and IEC 60601‐1:2005/AMD1:2012, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.
vi © ISO 2017 – All rights reserved
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)

References to clauses within this document are preceded by the term “Clause” followed by the clause number.

References to subclauses within this document are by number only.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the

conditions is true.

The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part 2.

For the purposes of this document, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance with this document;

– “should” means that compliance with a requirement or a test is recommended but is not mandatory for

compliance with this document; and

– “may” is used to describe a permissible way to achieve compliance with a requirement or test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is

guidance or rationale related to that item in Annex AA.
© ISO 2017 – All rights reserved vii
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SIST EN ISO 80601-2-61:2019
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SIST EN ISO 80601-2-61:2019
INTERNATIONAL STANDARD ISO 80601-2-61:2017(E)
Medical electrical equipment —
Part 2‐61:
Particular requirements for basic safety and essential
performance of pulse oximeter equipment
201.1 Scope, object and related standards
IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 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.

This document 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.

This document can also be applied to ME EQUIPMENT and their ACCESSORIES used for compensation or alleviation

of disease, injury or disability.

This document is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.

This document is not applicable to remote or slave (secondary) equipment that displays SpO 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.
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ISO 80601-2-61:2017(E)

This document 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.

This document is a particular standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.

201.1.2 Object
Subclause 1.2 of the general standard is replaced by:

The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for

PULSE OXIMETER EQUIPMENT [as defined in 201.3.217] and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the PULSE OXIMETER MONITOR and the ACCESSORIES needs to

be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of PULSE OXIMETER

EQUIPMENT.
201.1.3 Collateral standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.3 applies with the following addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of the general

standard and Clause 201.2 of this document.

IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified in

[2]

Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601‐1‐3 does not apply. All other published

collateral standards in the IEC 60601‐1 series apply as published.
201.1.4 Particular standards
IEC 60601‐1:2005+AMD1:2012, subclause 1.4 is replaced by:

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 the general standard or the collateral standards.

For brevity, IEC 60601‐1:2005+AMD1:2012 is referred to in this document as the general standard. Collateral

standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to 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 the general standard or applicable collateral standard is

replaced completely by the text of this document.

"Addition" means that the text of this document is additional to the requirements of the general standard or

applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is

amended as indicated by the text of this document.
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SIST EN ISO 80601-2-61:2019
ISO 80601-2-61:2017(E)

Subclauses or figures that are additional to those of the general standard are numbered starting from

201.101, 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 2xx,

where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for IEC 60601‐1‐3, etc.

The term "this document" is used to make reference to the general standard, any applicable collateral

standards and this particular document taken together.

Where there is no corresponding clause or subclause in this document, the section, clause or subclause of the

general standard or applicable collateral standard, although possibly not relevant, applies without

modification; where it is intended that any part of the general standard or applicable collateral standard,

although possibly relevant, is not to be applied, a statement to that effect is given in this 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.

NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in

whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
IEC 60601‐1:2005+AMD1:2012, Clause 2 applies, except as follows:
Replacement:
IEC 60417, Graphical symbols for use on equipment
IEC 60529:2013, Degrees of protection provided by enclosures (IP code)

IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests

IEC 60601‐1‐6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and

essential performance — Collateral standard: Usability
+ Amendment 1:2013

IEC 60601‐1‐8:2006, Medical electrical equipment — Part 1-8: General requirements for

...

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