EN ISO 80601-2-61:2011
(Main)Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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 informative Annex ZA, which is an integral part of this document.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-61:2011 has been approved by CEN as a EN ISO 80601-2-61:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the Member States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential requirements (ERs)
Qualifying remarks/Notes
of this European standard of EU Directive 93/42/EEC
all 1, 2, 3
201.4 1, 2, 3, 6
201.4.3 1, 2
201.4.101 2, 3
201.4.102 3, 6
201.4.103 6, 9.1
201.7 12.9, 13
201.7.2.3 13.2, 13.3 j), 13.3 k)
201.7.2.9 2, 9.1, 13.1
201.7.2.13.101 13.3 k)
201.7.2.17.101 8.3, 13.1, 13.2, 13.3 b), 13.3 d), 13.3 f), 13.5
201.7.2.101 9.1, 12.4, 13.2, 13.3 b), 13.3 d), 13.3 e),
13.3 f), 13.3 k), 13.5
201.7.2.4.101 13.3 e), 13.3 i)
201.7.4.3 10.3
201.7.9.1 13.3.a)
201.7.9.2.1.101 6, 13.6
201.7.9.2.1.101 a), 201.7.9.2.1.101 b) 13.4
201.7.9.2.1.101 c) 11.4.1, 13.6 j)
201.7.9.2.1.101 d) 13.6 b)
201.7.9.2.1.101 e) 13.6 b), 13.6 p)
201.7.9.2.1.101 f) 13.4
Table ZA.1 — (continued)
Clause(s)/sub-clause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
European standard Directive 93/42/EEC
201.7.9.2.1.101 g) 13.6 c)
201.7.9.2.1.101 h) 13.6 h)
201.7.9.2.1.101 i) 13.6 q)
201.7.9.2.2.101 13.6 c), 13.6 d)
201.7.9.2.8.101 13.6 i)
201.7.9.2.9.101 b) 13.6 a)
201.7.9.2.9.101 c), d) & e) 13.6 a), 13.6 b)
201.7.9.2.14.101 a) & b) 13.6 c)
201.7.9.2.14.101 c) 7.5
201.7.9.2.14.101 d) 13.6 g)
201.7.9.3.1.101 13.6 d)
201.8 12.6, 12.7.4
201.9 12.7.1
201.10 11.2.1, 11.2.2
201.11 6, 7.1, 7.2, 7.3, 7.5, 8.1, 8.2, 8.4, 8.6, 9.3,
12.7.5, 12.8.2
201.11.6.5.101 7.6
201.11.8.101 4, 12.2, 12.3
201.12.1 6, 10.1, 6a
201.12.4 6
201.12.4.101 9.1, 10.1, 10.2
201.12.4.102 10.1, 10.2, 12.4
201.14 12.1, 12.1 a)
201.15 12.7
201.15.3.5.101 4, 5, 9.2, 12.7.1
201.101.1 2, 3, 4, 5, 6, 6 a), 7.1, 7.6, 8.3, 9.1, 9.2,
10.1, 11.1.1, 11.2.2, 12.5, 12.6, 12.7.1,
12.7.5
201.101.2 9.1, 13.1
201.102 10.2
202 9.2, 11.3.1, 12.5
208 2, 6, 9.1, 10.2, 12.2, 12.3, 12.4
WARNING — Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 80601-2-61
First edition
2011-04-01
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 80601-2-61:2011(E)
©
ISO 2011
ISO 80601-2-61:2011(E)
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ISO 80601-2-61:2011(E)
Contents Page
Foreword .vi
Introduction.viii
201.1 Scope, object and related standards.1
201.1. 1 * Scope.1
201.1. 2 Object.1
201.1. 3 Collateral standards .2
201.1. 4 Particular standards .2
201.2 Normative references.3
201.3 Terms and definitions .4
201.4 General requirements .8
201.4. 3 ESSENTIAL PERFORMANCE.8
201.4. 101 * Additional requirements for ESSENTIAL PERFORMANCE .8
201.4. 102 Additional requirements for acceptance criteria .9
201.4. 103 Additional requirements for PULSE OXIMETER EQUIPMENT, parts and ACCESSORIES .9
201.5 General requirements for testing of ME EQUIPMENT.9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS.10
201.7 ME EQUIPMENT identification, marking and documents .10
201.7. 2.3 Consult ACCOMPANYING DOCUMENTS .10
201.7. 2.9 IP classification.10
201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME
EQUIPMENT parts.10
201.7. 2.4.101 Additional requirements for ACCESSORIES.11
201.7. 2.13.101 Additional requirements for physiological effects.11
201.7. 2.17.101 Additional requirements for protective packaging.11
201.7. 4.3 Unit of measure.12
201.7. 9.1 Additional general requirements.12
201.7. 9.2.1.101 Additional general requirements.
...
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