EN ISO 9919:2009

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC .4

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
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.
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
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
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.

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

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 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
50.101.1 * Specification .21
50.101.2 Determination of SpO accuracy.21
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

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
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 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
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-variability pulse oximeter probe in controlled desaturation
study on five test subjects .66
Figure FF.6 — Calibration of high-variability pulse oximeter probe in controlled desaturation
study on five test subjects (continued).67
Figure GG.1 — Illustration of fidelity of pulse oximeter equipment performance in tracking
saturation changes.68
Figure GG.2 — Illustration of effect of different averaging times on fidelity .69
Figure GG.3 — Graphic representation of components of alarm system delay.70
Figure GG.4 — Illustration of the effects of different averaging times on a more rapid and noisier
desaturation signal.71

vi © ISO 2005 – All rights reserved

ISO 9919:2005(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 shall not be held responsible for identifying any or all such patent rights.
ISO 9919 (IEC 60601-2-54) was prepared jointly by 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. The
draft was circulated for voting to the national bodies of both ISO and IEC.
This second edition cancels and replaces the first edition (ISO 9919:1992), which has been technically revised.
ISO 9919:2005(E)
Introduction
The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice
in many areas of medicine. This International Standard covers basic safety and essential performance
requirements achievable within the limits of existing technology.
Annex AA contains a rationale for some of the requirements. It is included to provide additional insight into the
committee’s reasoning that led to a requirement and identifying the hazards that the requirement addresses.
Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the interface
between a pulse oximeter probe and a patient’s tissue.
Annex CC discusses both the formulae used to evaluate the SpO accuracy of pulse oximeter equipment
measurements, and the names that are assigned to those formulae.
Annex DD presents guidance on when in vitro blood calibration of pulse oximeter equipment is needed.
Annex EE presents a guideline for controlled desaturation study for the calibration of pulse oximeter
equipment.
Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry.
Annex GG describes concepts of pulse oximeter equipment response time.
This International Standard is a Particular Standard, based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by or under the supervision of qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The
Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency
surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this International Standard, the following drafting conventions have been applied.
The changes to the text of IEC 60601-1:1988, the General Standard, as supplemented by the Collateral
Standards, are specified by the use of the following words.
 “Replacement” means that the indicated clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
 “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
element, note, table, figure) additional to the General Standard.
 “Amendment” means that existing text of the General Standard is partially modified by deletion and/or
addition as indicated by the text of this Particular Standard.
viii © ISO 2005 – All rights reserved

ISO 9919:2005(E)
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: clauses, subclauses, tables and figures are
numbered starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered
AA, BB, etc.
In this International Standard, the following print types are used:
 requirements, compliance with which can be tested, and definitions: roman type;
 notes and examples: smaller roman type;
 description of type of document change, and test specifications: italic type;
 terms defined in Clause 2 of the General Standard IEC 60601-1:1988 or in this Particular Standard: bold
type.
Throughout this Particular Standard, text for which a rationale is provided in Annex AA is indicated by an
asterisk (*).
INTERNATIONAL STANDARD ISO 9919:2005(E)

Medical electrical equipment — Particular requirements for the
basic safety and essential performance of pulse oximeter
equipment for medical use
1 Scope
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment (add at the end of 1.1):
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 SpO 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 7000/IEC 60417:2004, Graphical symbols for use on equipment — Index and synopsis
ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General
requirements
ISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical
investigation plans
ISO 9919:2005(E)
ISO 14937:2000, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
Amendment 1:2002.
Amendment 2:2004.
IEC 60068-2-6:1995, Environmental testing — Part 2-6: Tests — Test Fc. Vibration (sinusoidal)
IEC 60068-2-27:1987, Environmental testing — Part 2-27: Tests — Test Ea and guidance. Shock
IEC 60068-2-32:1975, Environmental testing — Part 2-32: Tests — Test Ed. Free fall
Amendment 1:1982
Amendment 2:1990
IEC 60068-2-64:1993, Environmental testing — Part 2-64: Test methods — Test Fh. Vibration, broad-band
random (digital control) and guidance
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature
Amendment 1:1995
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)
1)
IEC 60601-1:1988 , Medical electrical equipment — Part 1: General requirements for safety
Amendment 1:1991
Amendment 2:1995
IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment — Part 1-4: General requirements for safety — Collateral
Standard: Programmable electrical medical systems
Amendment 1:1999
IEC 60601-1-6:2004, Medical electrical equipment — Part 1-6: General requirements for safety — Collateral
standard: Usability
IEC 60601-1-8:2003, 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
IEC 60825-1:2001, Safety of laser products — Part 1: Equipment classification, requirements and user's guide
IEC 60825-2:2000, Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS)
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in IEC 60601-1:1988, Clause 2,
as amended by the Collateral Standards, and the following apply.
NOTE For convenience, the sources of all defined terms used in this International Standard are given in Annex JJ.

1) Currently under revision as IEC/CDV 60601-1:2004.
2 © ISO 2005 – All rights reserved

ISO 9919:2005(E)
3.1
accuracy
closeness of agreement between a test result and an accepted reference value
NOTE 1 See 50.101.2.2 for the method of calculating the SpO accuracy of pulse oximeter equipment.
NOTE 2 See also discussion in Annex CC.
NOTE 3 Adapted from ISO 3534-1:1993.
3.2
controlled desaturation study
hypoxaemia induced in a human subject performed under laboratory conditions
NOTE This can also be referred to a
...