EN ISO 80601-2-61:2011

SLOVENSKI STANDARD
01-julij-2011
1DGRPHãþD
SIST EN ISO 9919:2009
Elektromedicinska oprema - 2-61. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pulznega oksimetra (ISO 80601-2-61:2011)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO
80601-2-61:2011)
Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls (ISO 80601-2-61:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-61:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 80601-2-61
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.10 Supersedes EN ISO 9919:2009
English Version
Medical electrical equipment - Part 2-61: Particular requirements
for basic safety and essential performance of pulse oximeter
equipment (ISO 80601-2-61:2011)
Appareils électromédicaux - Partie 2-61: Exigences Medizinische elektrische Geräte - Teil 2-61: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les oxymètres de pouls (ISO 80601-2- wesentlichen Leistungsmerkmale von Pulsoximetriegeräten
61:2011) (ISO 80601-2-61:2011)
This European Standard was approved by CEN on 17 March 2011.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

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

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-61:2011: E
worldwide for CEN national Members.

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

Foreword
This document (EN ISO 80601-2-61:2011) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory
and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9919:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-61:2011 has been approved by CEN as a EN ISO 80601-2-61:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means to conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of
the Member States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential requirements (ERs)
Qualifying remarks/Notes
of this European standard of EU Directive 93/42/EEC
all 1, 2, 3
201.4 1, 2, 3, 6
201.4.3 1, 2
201.4.101 2, 3
201.4.102 3, 6
201.4.103 6, 9.1
201.7 12.9, 13
201.7.2.3 13.2, 13.3 j), 13.3 k)
201.7.2.9 2, 9.1, 13.1
201.7.2.13.101 13.3 k)
201.7.2.17.101 8.3, 13.1, 13.2, 13.3 b), 13.3 d), 13.3 f), 13.5
201.7.2.101 9.1, 12.4, 13.2, 13.3 b), 13.3 d), 13.3 e),
13.3 f), 13.3 k), 13.5
201.7.2.4.101 13.3 e), 13.3 i)
201.7.4.3 10.3
201.7.9.1 13.3.a)
201.7.9.2.1.101 6, 13.6
201.7.9.2.1.101 a), 201.7.9.2.1.101 b) 13.4
201.7.9.2.1.101 c) 11.4.1, 13.6 j)
201.7.9.2.1.101 d) 13.6 b)
201.7.9.2.1.101 e) 13.6 b), 13.6 p)
201.7.9.2.1.101 f) 13.4
Table ZA.1 — (continued)
Clause(s)/sub-clause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
European standard Directive 93/42/EEC
201.7.9.2.1.101 g) 13.6 c)
201.7.9.2.1.101 h) 13.6 h)
201.7.9.2.1.101 i) 13.6 q)
201.7.9.2.2.101 13.6 c), 13.6 d)
201.7.9.2.8.101 13.6 i)
201.7.9.2.9.101 b) 13.6 a)
201.7.9.2.9.101 c), d) & e) 13.6 a), 13.6 b)
201.7.9.2.14.101 a) & b) 13.6 c)
201.7.9.2.14.101 c) 7.5
201.7.9.2.14.101 d) 13.6 g)
201.7.9.3.1.101 13.6 d)
201.8 12.6, 12.7.4
201.9 12.7.1
201.10 11.2.1, 11.2.2
201.11 6, 7.1, 7.2, 7.3, 7.5, 8.1, 8.2, 8.4, 8.6, 9.3,
12.7.5, 12.8.2
201.11.6.5.101 7.6
201.11.8.101 4, 12.2, 12.3
201.12.1 6, 10.1, 6a
201.12.4 6
201.12.4.101 9.1, 10.1, 10.2
201.12.4.102 10.1, 10.2, 12.4
201.14 12.1, 12.1 a)
201.15 12.7
201.15.3.5.101 4, 5, 9.2, 12.7.1
201.101.1 2, 3, 4, 5, 6, 6 a), 7.1, 7.6, 8.3, 9.1, 9.2,
10.1, 11.1.1, 11.2.2, 12.5, 12.6, 12.7.1,
12.7.5
201.101.2 9.1, 13.1
201.102 10.2
202 9.2, 11.3.1, 12.5
208 2, 6, 9.1, 10.2, 12.2, 12.3, 12.4

WARNING — Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 80601-2-61
First edition
2011-04-01
Medical electrical equipment —
Part 2-61:
Particular requirements for basic safety
and essential performance of pulse
oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls

Reference number
ISO 80601-2-61:2011(E)
©
ISO 2011
ISO 80601-2-61:2011(E)
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ii © ISO 2011 – All rights reserved

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 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
201.12. 1.101.1 * Specification. 17
201.12. 1.101.2 Determination of SpO ACCURACY . 18
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

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
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 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

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 conducting new or revised tests. It is the recommendation of the committee that the content of
this publication be adopted for implementation nationally not earlier than 3 years from the date of publication
for equipment newly designed and not earlier than 5 years from the date of publication for equipment already
in production.
ISO 80601-2-61:2011(E)
Introduction
The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common practice
in many areas of medicine. This 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
reasoning of the committee 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 a 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.

viii © ISO 2011 – All rights reserved

INTERNATIONAL STANDARD ISO 80601-2-61:2011(E)

Medical electrical equipment —
Part 2-61:
Particular requirements for basic safety and essential
performance of pulse oximeter equipment
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Subclause 1.1 of The general standard is replaced by:
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
NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.
for
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.
PULSE OXIMETER EQUIPMENT intended for use in laboratory
This International Standard is not applicable to
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.
NOTE See also 4.2 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 SpO values
that are located outside of the PATIENT ENVIRONMENT.
201.1.2 Object
Subclause 1.2 of The general standard is replaced by:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for PULSE OXIMETER EQUIPMENT [as defined in 201.3.216] and its ACCESSORIES.
ISO 80601-2-61:2011(E)
NOTE ACCESSORIES are included because the combination of the PULSE OXIMETER MONITOR and the ACCESSORIES
needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE
OXIMETER EQUIPMENT.
201.1.3 Collateral standards
IEC 60601-1:2005, subclause 1.3 applies with the following addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and Clause 201.2 of this particular standard.
IEC 60601-1-3 does not apply.
NOTE Additional requirements for ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE
ENVIRONMENT are found in IEC 60601-1-11.
201.1.4 Particular standards
Subclause 1.4 of The general standard is replaced by:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the
general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other
BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards
are referred to by their document number.
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the
general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the
general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the
collateral standard document number (202.4 in this particular standard addresses the content of Clause 4 of
the 60601-1-2 collateral standard, 208.6 in this particular standard addresses the content of Clause 6 of the
60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the use
of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable collateral standard is
replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the general
standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable collateral standard is
amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the general standard are numbered starting from
201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x,
where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for IEC 60601-1-6, etc.
The term "this standard" is used to make reference to the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause
or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
2 © ISO 2011 – All rights reserved

ISO 80601-2-61:2011(E)
201.2 Normative references
The following referenced documents are indispensable for the application of this document. The way in which
these referenced documents are cited in normative requirements determines the extent (in whole or in part) to
which they apply. For dated references, only the edition cited applies. For undated references, the latest
edition of the referenced document (including any amendments) applies.
NOTE Informative references are listed in the bibliography beginning on page 76.
IEC 60601-1:2005, Clause 2 applies, except as follows:
Replacement:
IEC 60529:2001, Degrees of protection provided by enclosures (IP code)
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
IEC 60825-1:2007, Safety of laser products — Part 1: Equipment classification and requirements
Addition:
ISO 7000/IEC 60417:2004, Graphical symbols for use on equipment — Index and synopsis
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
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 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 15223-1:2007/Amd.1:2008
IEC 60068-2-27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks, primarily
for equipment-type specimens
IEC 60068-2-64:2008, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random
and guidance
IEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
IEC 60601-1-11:2010, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
ISO 80601-2-61:2011(E)
IEC 60825-2:2004, Safety of laser products — Part 2: Safety of optical fibre communication systems (OFCS)
IEC 60825-2:2004/Amd.1:2006
IEC/TR 60878:2003, Graphical symbols for electrical equipment in medical practice
IEC 62471:2006, Photobiological safety of lamps and lamp systems
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 apply, except as
follows.
NOTE An alphabetized index of defined terms is found beginning on page 81.
Addition:
201.3.201
ACCURACY
closeness of agreement between a test result and an accepted reference value
NOTE 1 Subclause 201.12.1.101.2.2 provides the method of calculating the SpO ACCURACY of PULSE OXIMETER
EQUIPMENT.
NOTE 2 Additional information is found in Annex CC.
NOTE 3 Adapted from ISO 3534-2:2006, 3.3.1.
201.3.202
CONTROLLED DESATURATION STUDY
hypoxaemia induced in a human subject performed under laboratory conditions
NOTE This can also be referred to as a controlled hypoxaemia (breathdown) study. Additional information is found in
Annex EE.
201.3.203
CO-OXIMETER
multiwavelength, optical blood analyser that measures TOTAL HAEMOGLOBIN CONCENTRATION and the
concentrations of various haemoglobin derivatives
NOTE The relevant CO-oximetry value is functional saturation of arterial blood, SaO , which PULSE OXIMETER
EQUIPMENT estimates and reports as SpO .
201.3.204
DATA UPDATE PERIOD
interval in which the PULSE OXIMETER EQUIPMENT algorithm provides new valid data to the display or the SIGNAL
INPUT/OUTPUT PART
NOTE This definition does not refer to the regular refresh period of the display, which is typically on the order of 1 s,
but rather to the (typically longer) interval defined above.
201.3.205
DECLARED RANGE
that portion of the DISPLAYED RANGE of SpO and pulse rate values over which there is specified ACCURACY
4 © ISO 2011 – All rights reserved

ISO 80601-2-61:2011(E)
201.3.206
DISPLAYED RANGE
range of SpO and pulse rate values that can be displayed by the PULSE OXIMETER EQUIPMENT
NOTE The DISPLAYED RANGE can extend beyond the DECLARED RANGE.
201.3.207
FRACTIONAL OXYHAEMOGLOBIN
FO Hb
fractional saturation (deprecated)
oxyhaemoglobin concentration cO Hb divided by the TOTAL HAEMOGLOBIN CONCENTRATION, ctHb, in the blood
cOHb
FOHb=
ctHb
NOTE 1 cO Hb is the concentration of oxyhaemoglobin; ctHb is the concentration of total haemoglobin.
NOTE 2 This is sometimes reported as a percentage (multiplying the fraction by 100).
NOTE 3 FRACTIONAL OXYHAEMOGLOBIN is the term used by the Clinical and Laboratory Standards Institute (CLSI,
(formerly NCCLS or National Committee for Clinical Laboratory Sciences) for this ratio.
NOTE 4 CLSI denotes “concentration” by a prefixed letter c, while in the past the convention of square brackets, e.g.
[O Hb], was used.
[13]
NOTE 5 CLSI uses the following notations:
⎯ oxyhaemoglobin (O Hb);
⎯ deoxyhaemoglobin (HHb);
⎯ carboxyhaemoglobin (COHb);
⎯ methaemoglobin (MetHb);
⎯ sulfhaemoglobin (SuHb); and
⎯ total haemoglobin (tHb).
201.3.208
FUNCTIONAL OXYGEN SATURATION
percentage saturation given by the oxyhaemoglobin concentration (cO Hb) divided by the sum of the
oxyhaemoglobin concentration and the deoxyhaemoglobin concentration (cHHb)
100× cO Hb
ccO Hb+ HHb
[13]
NOTE The CLSI term for this ratio is haemoglobin oxygen saturation, and its notation is SO .
201.3.209
FUNCTIONAL TESTER
test device which presents PULSE OXIMETER E
...