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)

ISO 80601-2-61:2011 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.
ISO 80601-2-61:2011 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.
ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability.
ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use.
ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.

Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO 80601-2-61:2011)

Abschnitt 1 der Allgemeinen Festlegungen gilt mit folgenden Abweichungen:
201.1.1 *Anwendungsbereich
Unterabschnitt 1.1 der Allgemeinen Festlegungen wird ersetzt durch:
Diese Internationale Norm gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale von
Pulsoximetriegeräten, die für die Anwendung an Menschen bestimmt sind. Sie werden nachfolgend als
ME-Gerät bezeichnet. Dies beinhaltet alle Teile, die für den bestimmungsgemäßen Gebrauch erforderlich
sind. Dies schließt den Pulsoximetriemonitor, den Pulsoximetriesensor und das Sensorverlängerungskabel
ein.
Diese Anforderungen gelten auch für Pulsoximetriegeräte einschließlich Pulsoximetriemonitoren, Pulsoximetriesensoren
und Sensorverlängerungskabel, die wiederaufgearbeitet wurden.
Der bestimmungsgemäße Gebrauch von Pulsoximetriegeräten beinhaltet, ist aber nicht begrenzt auf, die
Abschätzung der arteriellen Sauerstoffhämoglobinsättigung und Pulsfrequenz bei Patienten innerhalb und
außerhalb einer Gesundheitseinrichtung, einschließlich der Anwendung zur medizinischen Versorgung
häuslicher Umgebung.

Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2011)

L'ISO 80601-2-61:2011 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'usage prévu 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 santé professionnel ainsi que chez les patients soignés à domicile.
L'ISO 80601-2-61:2011 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.
L'ISO 80601-2-61:2011 peut également être appliquée aux oxymètres de pouls et à leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité.
L'ISO 80601-2-61:2011 ne s'applique pas aux oxymètres de pouls destinés à surveiller un foetus.
L'ISO 80601-2-61:2011 ne s'applique pas aux dispositifs distants ou esclaves (secondaires) qui affichent les valeurs de la SpO2 et qui sont situés à l'extérieur de l'environnement du patient.

Elektromedicinska oprema - 2-61. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra (ISO 80601-2-61:2011)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI PULZNEGA OKSIMETRA, namejnega uporabi pri ljudeh, v nadaljevanju OPREMA ME. To vključuje kateri koli del, potreben za OBIČAJNO UPORABO, pri čemer je izključen ZASLON PULZNEGA OKSIMETRA, SONDA PULZNEGA OKSIMETRA in PODALJŠEK KABLA SONDE. Te zahteve prav tako veljajo za PULZNI OKSIMETER, vključno z ZASLONI PULZNEGA OKSIMETRA, SONDAMI PULZENGA OKSIMETRA in PODALJŠKE KABLOV SOND, ki so bili PONOVNO UPORABLJENI. Predvidena uporaba PULZNEGA OKSIMETRA vključuje, vendar ni omejena na ocenjevanje, arterijsko nasičenost hemoglobina s kisikom in srčnega utripa BOLNIKOV v strokovnih zdravstvenih ustanovah in bolnikov v DOMAČEM ZDRAVSTVENEM OKOLJU. Ta mednarodni standard ne velja za PULZNE OKSIMETRE, namenjene za uporabo pri laboratorijskih raziskavah, niti za oksimetre, ki potrebujejo vzorec BOLNIKOVE krvi. Če je točka ali podtočka izrecno namenjena samo uporabi za OPREMO ME ali samo za SISTEME ME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno OPREMO ME in SISTEME ME. NEVARNOSTI, ki so del fiziološkega delovanja OPREME ME ali SISTEMOV ME na področju uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 201.11, 7.2.13 and 8.4.1. splošnega standarda. Ta standard se lahko uporabi tudi za PULZNE OKSIMETRE in njihove DODATKE, ki se uporabljajo za kompenziranje ali lajšanje bolezni, poškodbe ali prizadetosti. Ta emdnarodni standard ne velja za PULZNE OKSIMETRE, namenjene izključno fetalni uporabi. Ta mednarodni standrad ne velja za oddaljene ali podrejene (sekundarne) naprave, ki prikazujejo vrednosti SpO2 in so locirane zunaj BOLNIKOVEGA OKOLJA.

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2011
• Withdrawal Date: 29-Jan-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Jan-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: 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)

Relations

• Replaces: EN ISO 9919:2009 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
• Effective Date: 09-Apr-2011
• Replaced By: 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: 06-Feb-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-61:2011
01-julij-2011
1DGRPHãþD
SIST EN ISO 9919:2009
Elektromedicinska oprema - 2-61. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pulznega oksimetra (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)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO
80601-2-61:2011)
Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-61:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-61:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 80601-2-61:2011

---------------------- Page: 2 ----------------------

SIST EN ISO 80601-2-61:2011


EUROPEAN STANDARD
EN ISO 80601-2-61

NORME EUROPÉENNE

EUROPÄISCHE NORM
April 2011
ICS 11.040.10 Supersedes EN ISO 9919:2009
English Version
Medical electrical equipment - Part 2-61: Particular requirements
for basic safety and essential performance of pulse oximeter
equipment (ISO 80601-2-61:2011)
Appareils électromédicaux - Partie 2-61: Exigences Medizinische elektrische Geräte - Teil 2-61: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les oxymètres de pouls (ISO 80601-2- wesentlichen Leistungsmerkmale von Pulsoximetriegeräten
61:2011) (ISO 80601-2-61:2011)
This European Standard was approved by CEN on 17 March 2011.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-61:2011: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 80601-2-61:2011
EN ISO 80601-2-61:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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

SIST EN ISO 80601-2-61:2011
EN ISO 80601-2-61:2011 (E)
Foreword
This document (EN ISO 80601-2-61:2011) 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 October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9919:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive, see informativ
...