SIST 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)
This International Standard 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. This International Standard 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 standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This International Standard 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
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.
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SIST EN ISO 80601-2-61:2011
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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.
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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
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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 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.
3
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SIST EN ISO 80601-2-61:2011
EN ISO 80601-2-61:2011 (E)
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
4
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SIST EN ISO 80601-2-61:2011
EN ISO 80601-2-61:2011 (E)
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.
5
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SIST EN ISO 80601-2-61:2011
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SIST EN ISO 80601-2-61:2011
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
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SIST EN ISO 80601-2-61:2011
ISO 80601-2-61:2011(E)
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ii © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-61:2011
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.12
201.7. 9.2.2.101 Additional requirements for warnings and safety notices .13
201.7. 9.2.8.101 Additional requirements for start-up PROCEDURE.13
201.7. 9.2.9.101 Additional requirements for operating instructions .13
201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
material .14
201.7. 9.3.1.101 * Additional general requirements .14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.8. 3.101 Additional requirements for classification of APPLIED PARTS.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
201.11. 6.5.101 * Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT or ME SYSTEM .16
201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT .16
201.11. 8.101.1 Supply failure TECHNICAL ALARM CONDITION .16
201.11. 8.101.2 Settings and data storage following short interruptions or automatic switchover .16
201.11. 8.101.3 Operation following long interruptions .17
201.12 ACCURACY of controls and instruments and protection against hazardous outputs.17
© ISO 2011 – All rights reserved iii
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SIST EN ISO 80601-2-61:2011
ISO 80601-2-61:2011(E)
201.12. 1 ACCURACY of controls and instruments . 17
201.12. 1.101 * SpO accuracy of pulse oximeter equipment . 17
2
201.12. 1.101.1 * Specification. 17
201.12. 1.101.2 Determination of SpO ACCURACY . 18
2
201.12. 1.101.2.1 * Data collection . 18
201.12. 1.101.2.2 * Data analysis . 18
201.12. 1.101.2.3 Characteristics of the clinical study population . 19
201.12. 1.102 Accuracy under conditions of motion . 19
201.12. 1.103 ACCURACY under conditions of low perfusion . 19
201.12. 1.104 Pulse rate ACCURACY. 19
201.12. 4 Protection against hazardous output. 19
201.12. 4.101 * DATA UPDATE PERIOD. 19
201.12. 4.102 * Signal inadequacy . 20
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.13. 101 Detection of PULSE OXIMETER PROBE faults and PROBE CABLE EXTENDER faults. 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS). 20
201.15 Construction of ME EQUIPMENT. 21
201.15. 3.5.101 * Additional requirements for rough handling . 21
201.15. 3.5.101.1 * Shock and vibration. 21
201.15. 3.5.101.2 * Shock and vibration for professional transport . 22
201.15. 101 Mode of operation. 23
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
201.101. 1 General. 23
201.101. 2 Labelling . 24
201.102 Saturation pulse INFORMATION SIGNAL . 24
201.103 SIGNAL INPUT/OUTPUT PART. 24
201.103. 1 General. 24
201.103. 2 Connection to electronic health record. 24
201.103. 3 Connection to a distributed alarm system. 25
201.103. 4 Connection for remote control. 25
202 Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests . 25
202.6.2.1.1 IMMUNITY TEST LEVELS . 25
202.6.2.1.7 PATIENT simulation . 25
202.6.2.1.10 * Requirements. 26
202.6.2.3 * Radiated RF electromagnetic fields. 26
208 Medical electrical equipment — Part 1-8: General requirements for safety — Collateral
Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems. 26
208.6.1.2.101 * Additional requirements for ALARM CONDITION priority. 26
208.6.5.4.101 * Additional requirements for DEFAULT ALARM PRESET . 27
208.6.8.5.101 Additional requirements for ALARM SIGNAL inactivation states, indication and
access . 27
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS. 28
Annex D (informative) Symbols on marking. 32
Annex AA (informative) Particular guidance and rationale. 34
iv © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-61:2011
ISO 80601-2-61:2011(E)
Annex BB (informative) Skin temperature at the PULSE OXIMETER PROBE .41
Annex CC (informative) Determination of ACCURACY.45
Annex DD (informative) Calibration standards .53
Annex EE (informative) Guideline for evaluating and documenting SpO ACCURACY in human
2
subjects .54
Annex FF (informative) Simulators, calibrators and FUNCTIONAL TESTERS for PULSE OXIMETER
EQUIPMENT.61
Annex GG (informative) Concepts of ME EQUIPMENT response time.70
Annex HH (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO/TR 16142 .74
Bibliography.76
Alphabetized index of defined terms used in this standard .81
© ISO 2011 – All rights reserved v
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SIST EN ISO 80601-2-61:2011
ISO 80601-2-61:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
ISO 80601-2-61 was prepared by a Joint Working Group of Technical Committee 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, Electromedical
equipment.
This first edition of ISO 80601-2-61 cancels and replaces the second edition of ISO 9919:2005, which has
been revised to harmonize it with the third edition of IEC 60601-1:2005.
In this standard, 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 PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In referring to the structure of this standard, the term
⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
⎯ “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
References to subclauses within this standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
vi © ISO 2011 – All rights reserved
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SIST EN ISO 80601-2-61:2011
ISO 80601-2-61:2011(E)
⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
⎯ “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.
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for
...
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-61:2009
01-september-2009
Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene
lastnosti pulznega oksimetra za uporabo v medicini - 2-61. del (ISO/DIS 80601-2-
61:2009)
Medical electrical equipment - Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use - Part 2-61 (ISO/DIS 80601-2-
61:2009)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoxymetern zur medizischen
Anwendung (ISO/DIS 80601-2-61:2009)
Appareils électromédicaux - Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls à usage médical - Partie 2-61
(ISO/DIS 80601-2-61:2009)
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 80601-2-61:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-61:2009
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oSIST prEN ISO 80601-2-61:2009
EUROPEAN STANDARD
DRAFT
prEN ISO 80601-2-61
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.10 Will supersede EN ISO 9919:2005
English Version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of pulse oximeter
equipment for medical use - Part 2-61 (ISO/DIS 80601-2-
61:2009)
Appareils électromédicaux - Exigences particulières pour la Medizinische elektrische Geräte - Teil 2-61: Besondere
sécurité de base et les performances essentielles pour les Festlegungen für die Sicherheit einschließlich der
oxymètres de pouls à usage médical - Partie 2-61 (ISO/DIS wesentlichen Leistungsmerkmale von Pulsoxymetern zur
80601-2-61:2009) medizischen Anwendung (ISO/DIS 80601-2-61:2009)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 80601-2-61:2009: E
worldwide for CEN national Members.
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oSIST prEN ISO 80601-2-61:2009
prEN ISO 80601-2-61:2009 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 80601-2-61:2009
prEN ISO 80601-2-61:2009 (E)
Foreword
This document (prEN ISO 80601-2-61:2009) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 9919:2005.
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 EC Directive(s).
Endorsement notice
The text of ISO/DIS 80601-2-61:2009 has been approved by CEN as a prEN ISO 80601-2-61:2009 without
any modification.
3
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oSIST prEN ISO 80601-2-61:2009
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oSIST prEN ISO 80601-2-61:2009
DRAFT INTERNATIONAL STANDARD ISO/DIS 80601-2-61
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on Voting terminates on
2009-05-21 2009-10-21
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
INTERNATIONAL ELECTROTECHNICAL COMMISSION • МЕЖДУНАРОДНАЯ ЭЛЕКТРОТЕХНИЧЕСКАЯ КОММИСИЯ • COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
Medical electrical equipment — Particular requirements
for the basic safety and essential performance of pulse oximeter
equipment for medical use —
Part 2-61
Appareils électromédicaux — Exigences particulières pour la sécurité de base et les performances essentielles
pour les oxymètres de pouls à usage médical —
Partie 2-61
(Revision of ISO 9919:2005)
ICS 11.040.10
Please see the administrative notes on page ii-2
THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2009
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oSIST prEN ISO 80601-2-61:2009
ISO/DIS 80601-2-61
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Violators may be prosecuted.
ii © ISO 2009 – All rights reserved
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oSIST prEN ISO 80601-2-61:2009
ISO/DIS 80601-2-61
This draft is submitted to a parallel enquiry in ISO and a CDV vote in the IEC.
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated
in the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
distribué en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
© ISO 2009 – All rights reserved ii-2
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oSIST prEN ISO 80601-2-61:2009
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
1 Contents Page
2 Foreword .vi
3 Introduction.viii
4 201.1 Scope, object and related standards.1
5 201.1.1 Scope.1
6 201.1.2 Object.1
7 201.1.3 Collateral standards.2
8 201.1.4 Particular standards .2
9 201.2 Normative references .3
10 201.3 Terms and definitions.4
11 201.4 General requirements.8
12 201.4.3 Essential performance.8
13 201.4.101 Additional requirements for essential performance.9
14 201.4.102 Additional requirements for acceptance criteria .9
15 201.4.103 Additional requirements for pulse oximeter equipment, parts and accessories .9
16 201.5 General requirements for testing of me equipment .9
17 201.6 Classification of me equipment and me systems.10
18 201.7 Me equipment identification, marking and documents.10
19 201.7.2.3 Consult accompanying documents .10
20 201.7.2.9 IP classification .10
21 201.7.2.101 Additional requirements for marking on the outside of me equipment or
22 me equipment parts.10
23 201.7.2.4.101 Additional requirements for accessories.11
24 201.7.2.13.101 Additional requirements for physiological effects.11
25 201.7.2.17.101 Additional requirements for protective packaging.11
26 201.7.4.3 Unit of measure .12
27 201.7.9.1 Additional general requirements.12
28 201.7.9.2.1.101 Additional general requirements .12
29 201.7.9.2.2.101 Additional requirements for warnings and safety notices .13
30 201.7.9.2.8.101 Additional requirements for start-up procedure .13
31 201.7.9.2.9.101 Additional requirements for operating instructions.13
32 201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used
33 material .14
34 201.7.9.3.1.101 Additional general requirements .14
35 201.8 Protection against electrical hazards from me equipment.14
36 201.8.3.101 Additional requirements for classification of applied parts .14
37 201.8.7.4.7.101 Additional requirements for measurement of the patient leakage current .14
38 201.9 Protection against mechanical hazards of me equipment and me systems.15
39 201.10 Protection against unwanted and excessive radiation hazards.15
40 201.11 Protection against excessive temperatures and other hazards.15
41 201.11 6.5.101 Additional requirements for ingress of water or particulate matter into
42 me equipment or me system.15
43 201.11.8.101 Additional requirements for interruption of the power supply/supply mains to
44 me equipment.16
45 201.11.8.101.1 Supply failure technical alarm condition .16
46 201.11.8.101.2 Settings and data storage following short interruptions or automatic switchover .16
47 201.11.8.101.3 Operation following long interruptions.16
© ISO/IEC 2009 – All rights reserved iii
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
48 201.12 Accuracy of controls and instruments and protection against hazardous outputs .16
49 201.12.1 Accuracy of controls and instruments .17
50 201.12.1.101 SpO accuracy of pulse oximeter equipment.17
2
51 201.12.1.101.1 Specification .17
52 201.12.1.101.2 Determination of SpO accuracy.17
2
53 201.12.1.101.2.1 Data collection .17
54 201.12.1.101.2.2 Data analysis.18
55 201.12.1.101.2.3 Characteristics of the clinical study population.18
56 201.12.1.102 Accuracy under conditions of motion.19
57 201.12.1.103 Accuracy under conditions of low perfusion .19
58 Pulse rate accuracy .19
201.12.1.104
59 201.12.4 Protection against hazardous output.19
60 201.12.4.101 Data update period .19
61 201.12.4.102 Signal inadequacy .19
62 201.13 Hazardous situations and fault conditions .20
63 201.13.101 Detection of pulse oximeter probe faults and probe cable extender faults.20
64 201.14 Programmable electrical medical systems (pems) .20
65 201.15 Construction of me equipment .20
66 201.15.3.5.101 Additional requirements for rough handling .20
67 201.15.3.5.101.1 Shock and vibration.20
68 201.15.3.5.101.2 Shock and vibration for professional transport .21
69 201.15.101 Mode of operation .23
70 201.16 Me systems.23
71 201.17 Electromagnetic compatibility of me equipment and me systems .23
72 201.101 Pulse oximeter probes and probe cable extenders.23
73 201.101.1 General.23
74 201.101.2 Labelling .23
75 201.102 Saturation pulse information signal .24
76 202 Medical electrical equipment – Part 1-2: General requirements for safety – Collateral
77 standard: Electromagnetic compatibility – Requirements and tests.24
78 202.6.2.1.1 Immunity test levels .24
79 202.6.2.1.7 Patient simulation .24
80 202.6.2.1.10 Requirements .24
81 202.6.2.3 Radiated RF electromagnetic fields .25
82 208 Medical electrical equipment – Part 1-8: General requirements for safety - Collateral
83 Standard: General requirements, tests and guidance for alarm systems in medical
84 electrical equipment and medical electrical systems .25
85 208.6.1.2.101 Additional requirements for alarm condition priority .25
86 208.6.5.4.101 Additional requirements for default alarm preset .25
87 208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and
88 access .26
89 Annex C (informative) Guide to marking and labelling requirements for me equipment and
90 me systems .27
91 Annex D (informative) Symbols on marking.31
92 Annex AA (informative) Particular guidance and rationale.33
93 Annex BB (informative) Skin temperature at the pulse oximeter probe.40
94 Annex CC (informative) Determination of accuracy .44
95 Annex DD (informative) Calibration standards .52
iv © ISO/IEC 2009 – All rights reserved
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
96 Annex EE (informative) Guideline for evaluating and documenting SpO accuracy in human
2
97 subjects .53
98 Annex FF (informative) Simulators, calibrators and functional testers for pulse oximeter
99 equipment.60
100 Annex GG (informative) Concepts of me equipment response time.69
101 Annex HH (informative) Reference to the Essential Principles.73
102 Annex II (informative) Environmental aspects .75
103 Annex ZA (informative) Relationship between this International Standard and the Essential
104 Requirements of EU Directive 93/42/EEC.77
105 Bibliography.79
106 Alphabetized index of defined terms used in this standard.84
107
© ISO/IEC 2009 – All rights reserved v
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
108 Foreword
109 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
110 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
111 technical committees. Each member body interested in a subject for which a technical committee has been
112 established has the right to be represented on that committee. International organizations, governmental and
113 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
114 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
115 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
116 The main task of technical committees is to prepare International Standards. Draft International Standards
117 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
118 International Standard requires approval by at least 75 % of the member bodies casting a vote.
119 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
120 rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
121 ISO/IEC 80601-2-61 was prepared by a Joint Working Group of Technical Committee ISO/TC 121,
122 Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and
123 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D,
124 Electromedical equipment.
125 This first edition cancels and replaces the second edition of ISO 9919:2005, which has been revised to
126 harmonize it with the third edition of IEC 60601-1:2005.
127 In this standard, the following print types are used:
128 ⎯ Requirements and definitions: roman type.
129 ⎯ Test specifications: italic type.
130 ⎯ Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative
131 text of tables is also in a smaller type.
132 ⎯ Terms defined in Clause 3 of the general standard, in this particular standard or as noted: bolded
133 roman type.
134 In referring to the structure of this standard, the term
135 ⎯ “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
136 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
137 ⎯ “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
138 Clause 7).
139 References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
140 References to subclauses within this collateral standard are by number only.
141 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
142 the conditions is true.
143 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
144 2. For the purposes of this standard, the auxiliary verb:
vi © ISO/IEC 2009 – All rights reserved
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
145 ⎯ “shall” means that compliance with a requirement or a test is mandatory for compliance with this
146 standard;
147 ⎯ “should” means that compliance with a requirement or a test is recommended but is not mandatory for
148 compliance with this standard;
149 ⎯ “may” is used to describe a permissible way to achieve compliance with a requirement or test.
150 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
151 there is guidance or rationale related to that item in Annex AA.
152 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
153 and testing organizations may need a transitional period following publication of a new, amended or revised
154 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
155 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
156 this publication be adopted for implementation nationally not earlier than 3 years from the date of publication
157 for equipment newly designed and not earlier than 5 years from the date of publication for equipment already
158 in production.
159
© ISO/IEC 2009 – All rights reserved vii
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oSIST prEN ISO 80601-2-61:2009
ISO/IEC DIS 80601-2-61
160 Introduction
161 The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice
162 in many areas of medicine. This International Standard covers basic safety and essential performance
163 requirements achievable within the limits of existing technology.
164 Annex AA contains a rationale for some of the requirements. It is included to provide
...
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