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.

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Published
Publication Date
29-Jan-2019
Withdrawal Date
30-Jan-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Jan-2019
Completion Date
30-Jan-2019

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Standards Content (Sample)

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
2

---------------------- Page: 4 ----------------------

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 o
...

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-61:2017
01-januar-2017
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLSXO]QHJDRNVLPHWUD ,62',6
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2016)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO/DIS
80601-2-61:2016)
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-
61:2016)
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
oSIST prEN ISO 80601-2-61:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-61:2017

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oSIST prEN ISO 80601-2-61:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-61
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-10-24 2017-01-15
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
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-61:2016(E)
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. ISO 2016

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oSIST prEN ISO 80601-2-61:2017
ISO/DIS 80601-2-61:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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copyright@iso.org
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ii © ISO 2016 – All rights reserved

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oSIST prEN ISO 80601-2-61:2017
ISO/DIS 80601-2-61:2016(E) – 3 –
1 CONTENTS
2 CONTENTS .3
3 FOREWORD .5
4 INTRODUCTION .9
5 201.1 Scope, object and related standards . 11
6 201 2 Normative references. 13
7 201.3 Terminology and definitions. 15
8 201.5 General requirements for testing of ME EQUIPMENT . 21
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 22
10 201.7 ME EQUIPMENT identification, marking and documents . 22
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 26
12 201.9 Protection against mechanical HAZARDS o
...

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