SIST EN ISO 9919:2009
(Main)Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
This International Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has 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 on patients in healthcare institutions as well as on patients in home care. This International Standard is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient. This International Standard is not applicable to pulse oximeter equipment solely intended 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. The requirements of this International Standard which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den medizinischen Gebrauch (ISO 9919:2005)
IEC 60601-1:1988, Abschnitt 1 gilt mit folgenden Abweichungen.
Ergänzung (nach 1.1):
Diese Allgemeinen Festlegungen spezifizieren besondere Anforderungen für die grundlegende Sicherheit
und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten. Dies beinhaltet alle Teile, die für den
bestimmungsgemäßen Gebrauch erforderlich sind, z. B. den Pulsoximetriemonitor, den Pulsoximetriesensor
oder das Sensorverlängerungskabel.
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 des Krankenhauses, einschließlich der Anwendung in häuslicher Umgebung.
* Diese Besonderen Festlegungen gelten nicht für Pulsoximetriegeräte, die für den Gebrauch in Laborforschungsanwendungen
bestimmt sind, und Pulsoximeter, die eine Blutprobe von Patienten benötigen.
Diese Besonderen Festlegungen gelten nicht für Pulsoximetriegeräte, die für den Einsatz bei Ungeborenen
bestimmt sind;
Diese Besonderen Festlegungen gelten nicht für entfernt aufgestellte oder gekoppelte Geräte, die SpO2-
Werte anzeigen und die sich außerhalb der Patientenumgebung befinden.
Anforderungen dieser Besonderen Festlegungen, die Anforderungen der IEC 60601-1:1988 einschließlich
ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder ändern, haben Vorrang vor den entsprechenden
Allgemeinen Festlegungen.
Appareils électromédicaux - Règles particulières de sécurité et performances essentielles du matériel utilisé pour les oxymètres de pouls à usage médical (ISO 9919:2005)
Pour les besoins de l'ISO 9919:2005, le domaine d'application de la CEI 60601-1:1998 (Article 1) s'applique avec les modifications et les ajouts suivants.
Amendement (à ajouter à la fin de 1.1):
L'ISO 9919:2005 spécifie les exigences particulières de sécurité minimale et de performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains. Sont inclus tous les éléments de l'appareil nécessaires pour une utilisation normale, tels que le moniteur de l'oxymètre de pouls, le capteur de l'oxymètre de pouls, 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 soins ainsi que chez les patients soignés à domicile.
L'ISO 9919:2005 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 9919:2005 ne s'applique pas aux oxymètres de pouls destinés à surveiller un fœtus.
L'ISO 9919:2005 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.
Les exigences de l'ISO 9919:2005 qui remplacent ou modifient les exigences de la CEI 60601-1:1998 et ses Amendements 1 (1991) et 2 (1995), sont destinées à avoir la priorité sur les exigences générales correspondantes
Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9919:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 9919:2005
Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene
lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)
Medical electrical equipment - Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use (ISO 9919:2005)
Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende
Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den
medizinischen Gebrauch (ISO 9919:2005)
Appareils électromédicaux - Règles particulières de sécurité et performances
essentielles du matériel utilisé pour les oxymètres de pouls à usage médical (ISO
9919:2005)
Ta slovenski standard je istoveten z: EN ISO 9919:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9919:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9919:2009
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SIST EN ISO 9919:2009
EUROPEAN STANDARD
EN ISO 9919
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes 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 (ISO 9919:2005)
Appareils électromédicaux - Règles particulières de Medizinische elektrische Geräte Besondere Festlegungen
sécurité et performances essentielles du matériel utilisé für die grundlegende Sicherheit und die wesentlichen
pour les oxymètres de pouls à usage médical (ISO Leistungsmerkmale von Pulsoximetriegeräten für den
9919:2005) medizinischen Gebrauch (ISO 9919:2005)
This European Standard was approved by CEN on 14 March 2009.
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 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 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.
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. EN ISO 9919:2009: E
worldwide for CEN national Members.
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SIST EN ISO 9919:2009
EN ISO 9919:2009 (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 9919:2009
EN ISO 9919:2009 (E)
Foreword
The text of ISO 9919:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 9919:2009 by 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 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 9919:2005.
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.
For relationship with EC 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, 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 9919:2005 has been approved by CEN as a EN ISO 9919:2009 without any modification.
3
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SIST EN ISO 9919:2009
EN ISO 9919:2009 (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 of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities 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)/Subclause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (Ers) of EU Directive
93/42/EEC
All 1, 2, 3
4.101, 4.102 3, 6
4.103 6, 9.1
6.1 2,9.1, 13.1
This relevant Essential
- 12.1a)
Requirement is not addressed
in this European Standard.
This relevant Essential
6.1 d) 13.3 (a):
Requirement is not fully
addressed in this European
Standard
This relevant Essential
6.1 13.3 (f)
Requirement is not fully
addressed in this European
Standard
This relevant Essential
6.1 13.6 (h)(2nd paragraph)
Requirement is not fully
addressed in this European
Standard
This relevant Essential
6.1 13.6 (h)(3rd paragraph)
Requirement is not addressed
in this European Standard
This relevant Essential
6.8.2 aa) 21 7.5 (3rd paragraph)
Requirement is not fully
addressed in this European
Standard
This relevant Essential
6.8.2 13.6 (q)
Requirement is not addressed
in this European Standard:
covered by EN ISO 13485:
2003, subclause 4.2.3
4
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SIST EN ISO 9919:2009
EN ISO 9919:2009 (E)
Table ZA.1 (continued)
Clause(s)/Subclause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (Ers) of EU Directive
93/42/EEC
6.1 d) 1st dash 13.1
th
6.1 d) 4 dash 12.4
6.1 f) 9.1, 13.1
6.1 aa) 10.3
6.1 bb) 13.3 f), 13.6 h)
6.1 cc) 13.3 c), 13.3 m)
6.1 dd) 13.3 e)
6.8.2 6, 13.6
6.8.2 aa) 1) 13.6 b)
6.8.2 aa) 2) 11.4.1, 13.6 j)
6.8.2 aa) 3) 13.6 b), 13.6 f), 13.6 k), 13.6 l)
6.8.2 aa) 4) 13.6 b), 13.6 p)
6.8.2 aa) 5) 13.6 b)
6.8.2 aa) 7) 13.6 d)
6.8.2 aa) 11), 6.8.2 aa) 12) 13.6 c)
6.8.2 aa) 13), 6.8.2 aa) 14), 13.6 b)
6.8.2 aa) 15), 6.8.2 aa) 16),
6.8.2 aa) 17),
6.8.2 aa) 19) 13.6 g)
6.8.2 aa) 20) 13.6 c), 13.6 d)
6.8.2 aa) 21) 13.4
6.8.3 aa) 1), 6.8.3 aa) 2) 13.6 d)
10.1.1 8.3
19.4 12.6
20.4 12.6
21 4, 5, 9.2, 12.7.1
29, 30, 31 11.2.1
32 11.1.1, 11.2.1, 11.2.2
33, 34, 35 11.2.1
36 9.2, 11.3.1, 12.5
42 12.7.5, 12.8.2
42.3 6
43.101 7.1, 7.3, 9.3
44.6 7.6
44.7 8.1, 8.4, 8.6
46 10.2
48 7.1, 7.2, 7.5, 8.2
5
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SIST EN ISO 9919:2009
EN ISO 9919:2009 (E)
Table ZA.1 (continued)
Clause(s)/Subclause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (Ers) of EU Directive
93/42/EEC
st
48 7.5 (1 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
49 4, 12.2, 12.3
50 6, 10.1, 14
50.101.2 6a) This relevant Essential
Requirement is not fully
addressed in this European
Standard
51 6
51.101 9.1, 10.1 10.2
52 12.1
57.3 12.7.4
101 10.1, 10.2, 12.4
102.1 2, 3, 4, 5, 6, 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, 14
102.2 9.1, 13.1
103 10.2
201 2, 6, 9.1, 10.2, 12.2, 12.3, 12.4
WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
6
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SIST EN ISO 9919:2009
INTERNATIONAL ISO
STANDARD 9919
Second edition
2005-03-15
Medical electrical equipment — Particular
requirements for the basic safety and
essential performance of pulse oximeter
equipment for medical use
Appareils électromédicaux — Règles particulières de sécurité et
performances essentielles du matériel utilisé pour les oxymètres de
pouls à usage médical
Reference number
ISO 9919:2005(E)
©
ISO 2005
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SIST EN ISO 9919:2009
ISO 9919:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 9919:2009
ISO 9919:2005(E)
Contents Page
Foreword. vii
Introduction . viii
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and requirements for tests . 7
4.101 Other test methods . 7
4.102 Acceptance criteria . 8
4.103 Pulse oximeter equipment, parts and accessories . 8
5 Classification. 8
6 Identification, marking and documents. 8
6.1 Marking on the outside of equipment or equipment parts . 8
6.8.1 General. 9
6.8.2 Instructions for use. 9
6.8.3 Technical description . 11
7 Power input. 11
8 Basic safety categories . 11
9 Removable protective means . 11
10 Environmental conditions. 12
10.1 Transport and storage . 12
11 Not used. 12
12 Not used. 12
13 General. 12
14 Requirements related to classification . 12
14.6 Types B, BF and CF equipment. 12
15 Limitation of voltage and/or energy . 12
16 Enclosures and protective covers . 12
17 Separation. 12
18 Protective earthing, functional earthing and potential equalization . 12
19 Continuous leakage currents and patient auxiliary currents . 13
19.4 Tests. 13
20 Dielectric strength. 13
20.4 Tests. 13
21 * Mechanical strength. 13
21.5 13
21.101 * Shock and vibration . 13
21.102 * Shock and vibration for transport. 14
22 Moving parts. 15
23 Surfaces, corners and edges. 15
24 Stability in normal use. 15
© ISO 2005 – All rights reserved iii
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SIST EN ISO 9919:2009
ISO 9919:2005(E)
25 Expelled parts.15
26 Vibration and noise .16
27 Pneumatic and hydraulic power .16
28 Suspended masses.16
29 X-Radiation.16
30 Alpha, beta, gamma, neutron radiation and other particle radiation.16
31 Microwave radiation.16
32 Light radiation (including lasers).16
33 Infra-red radiation.16
34 Ultraviolet radiation.16
35 Acoustical energy (including ultrasonics).16
36 * Electromagnetic compatibility.17
37 Locations and basic requirements.17
38 Marking, accompanying documents .17
39 Common requirements for category AP and category APG equipment .17
40 Requirements and tests for category AP equipment, parts and components thereof .17
41 Requirements and tests for category APG equipment, parts and components thereof .17
42 Excessive temperatures .18
43 Fire prevention.18
43.101 * Pulse oximeter equipment used in conjunction with oxidants.18
43.101.1 Ignitable material .18
43.101.2 Sparking.19
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.19
44.6 * Ingress of liquids .19
44.7 Cleaning, sterilization and disinfection .19
45 Pressure vessels and parts subject to pressure .19
46 Human errors .20
47 Electrostatic charges .20
48 Biocompatibility.20
49 Interruption of the power supply .20
49.101 Power-failure alarm condition.20
49.102 Pulse oximeter equipment operation following interruption of the power supply.20
49.102.1 Settings and data storage following short interruptions or automatic switchover.20
49.102.2 Operation following long interruptions .20
50 Accuracy of operating data .21
50.101 * SpO accuracy of pulse oximeter equipment .21
2
50.101.1 * Specification .21
50.101.2 Determination of SpO accuracy.21
2
50.102 Accuracy under conditions of motion.22
50.103 Accuracy under conditions of low perfusion .22
50.104 Pulse rate accuracy.23
51 Protection against hazardous output.23
51.101 * Data update period .23
51.102 Detection of pulse oximeter probe and probe cable extender fault.23
iv © ISO 2005 – All rights reserved
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SIST EN ISO 9919:2009
ISO 9919:2005(E)
52 Abnormal operation and fault-conditions . 23
53 Environmental tests. 24
54 General. 24
55 Enclosures and covers. 24
56 Components and general assembly .24
57 Mains parts, components and layout. 24
58 Protective earthing — Terminals and connections . 24
59 Construction and layout. 24
101 * Signal inadequacy . 24
102 * Pulse oximeter probes and probe cable extenders . 25
102.1 General. 25
102.2 Labelling. 25
103 Saturation pulse information signal. 25
104 Alarm systems. 25
201.1.2 * Assignment of priority . 25
201.5.4 * Default alarm preset . 26
201.8 Alarm signal inactivation states . 26
201.8.3 Indication and access. 26
105 Appendices of IEC 60601-1:1988. 26
Annex AA (informative) Rationale. 27
Annex BB (informative) Skin temperature at the pulse oximeter probe . 38
Annex CC (informative) Determination of accuracy. 42
Annex DD (informative) Calibration standards. 50
Annex EE (informative) Guideline for evaluating and documenting SpO accuracy in human
2
subjects. 51
Annex FF (informative) Simulators, calibrators and functional testers for pulse oximeter
equipment . 58
Annex GG (informative) Concepts of equipment response time. 68
Annex HH (informative) Reference to the Essential Principles . 72
Annex II (informative) Environmental aspects. 74
Annex JJ (informative) Index of defined terms. 76
Bibliography . 78
Tables
Table AA.1 — Qualitative assessment of pulse oximeter equipment shock and vibration
environment. 28
Table AA.2 — Allowable maximum temperatures for skin contact with medical electrical
equipment applied parts (adapted from Table 22, IEC/CDV 60601-1:2004) . 30
Table BB.1 — Pulse oximeter probe safe application time and source . 40
Table EE.1 — Example of target plateaus and ranges . 54
Table HH.1 — Correspondence between this International Standard and the Essential Principles. 72
Table II.1 — Environmental aspects addressed by clauses of this International Standard. 75
© ISO 2005 – All rights reserved v
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SIST EN ISO 9919:2009
ISO 9919:2005(E)
Figures
Figure CC.1 — Synthesized calibration data (base case) .
...
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