SIST 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)

SIST EN-ISO 80601-2-61 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. 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 SpO2 values that are located outside of the PATIENT ENVIRONMENT. 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.

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)

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
• Public Enquiry End Date: 09-Jan-2017
• Publication Date: 18-Mar-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 18-Feb-2019
• Due Date: 25-Apr-2019
• Completion Date: 19-Mar-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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)

Relations

• Replaces: SIST EN ISO 80601-2-61:2011 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
• Effective Date: 01-Apr-2019

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3
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
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
ISO 80601-2-61:2017(E)
© 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
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Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Published in Switzerland
ii
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

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

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/directive
...