SIST EN 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)

Revision of EN 865:1997 (TC Res 320/1999) (CC/000124).

Medizinische elektrische Geräte Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Pulsoximetriegeräten für den medizinischen Gebrauch (ISO 9919:2005)

Ergänzung:
Diese Besonderen 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 Pulsoximetrie-sensor, oder das Kabel.
Diese Anforderungen gelten auch für Pulsoximetriegeräte einschließlich Pulsoximetriemonitoren, Puls-oxi-metrie-sensoren und Kabeln, 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.
Pulsoximetriegeräte, die für den Gebrauch in Laborforschungsanwendungen bestimmt sind, und Pulsoximeter, die eine Blutprobe von Patienten benötigen, liegen außerhalb des Anwendungsbereichs dieser Besonderen Festlegungen.
Pulsoximetriegeräte, die für die Überwachung von Ungeborenen bestimmt sind, liegen außerhalb des Anwen-dungs-bereichs dieser Besonderen Festlegungen.
Entfernt aufgestellte oder gekoppelte Geräte, die SpO2-Werte anzeigen und die sich außerhalb der Pati-en-ten-umgebung befinden, liegen außerhalb des Anwendungsbereichs dieser Besonderen Festlegungen.

Appareils électromédicaux - Regles particulieres de sécurité et performances essentielles du matériel utilisé pour les oxymetres de pouls a usage médical (ISO 9919:2005)

Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene lastnosti pulznega oksimetra za uporabo v medicini (ISO 9919:2005)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2005
• Withdrawal Date: 15-Apr-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Apr-2009
• Due Date: 09-May-2009
• Completion Date: 16-Apr-2009
• 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: EN 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)

Relations

• Replaced By: SIST 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: 01-May-2009
• Replaced By: SIST 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: 08-Jun-2022
• Replaces: SIST EN 865:2000 - Pulse oximeters - Particular requirements
• Effective Date: 01-Jun-2005

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9919:2005
01-junij-2005
1DGRPHãþD
SIST EN 865:2000
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 - Regles particulieres de sécurité et performances
essentielles du matériel utilisé pour les oxymetres de pouls a usage médical (ISO
9919:2005)
Ta slovenski standard je istoveten z: EN ISO 9919:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9919:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9919:2005

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SIST EN ISO 9919:2005



EUROPEAN STANDARD
EN ISO 9919

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2005
ICS 11.040.10 Supersedes EN 865:1997
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 February 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.




EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9919:2005: E
worldwide for CEN national Members.

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SIST EN ISO 9919:2005

EN ISO 9919:2005 (E)





Foreword


This document (EN ISO 9919:2005) 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 September 2005, and conflicting national
standards shall be withdrawn at the latest by September 2005.

This document supersedes EN 865:1997.

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(s), 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,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.



Endorsement notice

The text of ISO 9919:2005 has been approved by CEN as EN ISO 9919:2005 without any
modifications.

2

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SIST EN ISO 9919:2005

EN ISO 9919:2005 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC Medical devices



This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC, Council Directive of 14 June
1993 on the approximations 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 Communities under that
Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative 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
6.1 d), 6.1 f) 13.2, 13.3 b), 13.3 d), 13.5
st
6.1 d) 1 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)

3

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SIST EN ISO 9919:2005
EN ISO 9919:2005 (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
6.8.2 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
49 4, 12.2, 12.3
50 6, 10.1, 14
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.

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SIST EN ISO 9919:2005


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 9919:2005
ISO 9919:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 9919:2005
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 9919:2005
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 9919:2005
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 9919:2005
ISO 9919:2005(E)
Figures
Figure CC.1 — Synthesized calibration data (base case) .43
Figure CC.2 — Constant offset has been added to base case .44
Figure CC.3 — Tilt has been added to base case .45
Figure CC.4 — Graphical representation for the definition of local bias (Test sensor SpO as a
2
function of reference S ) .46
R
Figure CC.5 — Graphical representation for the definition of local bias and mean bias (Test
sensor SpO as a function of reference S ) .46
2 R
Figure EE.1 — Example of desaturation-time profile .54
Figure FF.1 — Sample calibration curve for pulse oximeter equipment .60
Figure FF.2 — Interface of a functional tester that uses a photodiode and LED to interact with a
pulse oximeter probe .61
Figure FF.3 — Interface of a functional tester that uses a dye mixture.62
Figure FF.4 — Interface of a functional tester that uses a liquid crystal modulator.63
Figure FF.5 — Absorbency of blue bandage material (measured in reflection) used in a special
test pulse oximeter probe with great patient-to-patient variability of calibration .65
Figure FF.6 — Calibration of high-variabi
...