oSIST prEN ISO 80601-2-61:2025

SLOVENSKI STANDARD
01-januar-2025
Medicinska električna oprema - 2-61. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pulznega oksimetra (ISO/DIS 80601-2-61:2024)
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment (ISO/DIS 80601-2-61:2024)
Medizinische elektrische Geräte - Teil 2-61: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Pulsoximetriegeräten (ISO/DIS
80601-2-61:2024)
Appareils électromédicaux - Partie 2-61: Exigences particulières pour la sécurité de base
et les performances essentielles pour les oxymètres de pouls (ISO/DIS 80601-2-
61:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-61
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
Particular requirements for basic 2024-11-18
safety and essential performance of
Voting terminates on:
2025-02-10
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
ICS: 11.040.10; 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 80601-2-61:2024(en)
DRAFT
ISO/DIS 80601-2-61:2024(en)
International
Standard
ISO/DIS 80601-2-61
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-61:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
pulse oximeter equipment
Appareils électromédicaux —
Partie 2-61: Exigences particulières pour la sécurité de base et les
performances essentielles pour les oxymètres de pouls
ICS: 11.040.10; 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-61:2024(en)
ii
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
1 Contents Page
2 201.1 Scope, object, and related standards . 1
3 201.2 Normative references . 3
4 201.3 Terms and definitions . 4
5 201.4 General requirements .18
6 201.5 General requirements for testing of ME equipment .19
7 201.6 Classification of ME equipment and ME systems .19
8 201.7 ME equipment identification, marking and documents .19
9 201.8 Protection against electrical hazards from ME equipment .24
10 201.9 Protection against mechanical hazards of ME equipment and ME systems .24
11 201.10 Protection against unwanted and excessive radiation hazards .24
12 201.11 Protection against excessive temperatures and other hazards .24
13 201.12 Accuracy of controls and instruments and protection against hazardous outputs .26
14 201.13 Hazardous situations and fault conditions for ME equipment .40
15 201.14 Programmable electrical medical systems (PEMS).40
16 201.15 Construction of ME equipment .41
17 201.16 ME systems .42
18 201.17 Electromagnetic compatibility of ME equipment and ME systems .43
19 201.101 Pulse oximeter probes and probe cable extenders .43
20 201.102 Saturation pulse information signal .44
21 201.103 Functional connection .44
22 202 Electromagnetic disturbances – Requirements and tests .44
23 202.4.3.1 Configurations .44
24 202.5.2.2.1 Requirements applicable to all ME equipment and ME systems .45
25 202.8.1.101 Additional general requirements .45
26 202.8.2 Patient physiological simulation .45
27 206 Usability .46
28 208 General requirements, tests and guidance for alarm systems in medical
29 electrical equipment and medical electrical systems .46
30 208.6.1.2.101 Additional requirements for alarm condition priority .46
31 208.6.5.4.101 Additional requirements for default alarm preset .46
32 208.6.8.5.101 Additional requirements for alarm signal inactivation states,
33 indication and access .47
34 211 Requirements for medical electrical equipment and medical electrical
35 systems used in the home healthcare environment .47
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36 212 Requirements for medical electrical equipment and medical electrical

37 systems used in the emergency medical services environment. 47
38 Annex C (informative) Guide to marking and labelling requirements for
39 ME equipment and ME systems . 48
40 Annex D (informative) Symbols on marking . 52
41 Annex AA (informative) Particular guidance and rationale . 53
42 Annex BB (informative) Skin temperature at the pulse oximeter probe . 75
43 Annex CC (informative) Determination of accuracy . 79
44 Annex DD (informative) Calibration standards . 89
45 Annex EE (normative) Method for controlled desaturation studies for evaluating and
46 documenting SpO2 accuracy in human participants . 90
47 Annex FF (informative) Simulators, calibrators, and functional testers for
48 pulse oximeter equipment . 97
49 Annex GG (informative) Concepts of ME equipment response time . 106
50 Annex HH (normative) Data interface requirements . 110
51 Annex II (informative) Clinical context and rationales . 116
52 Annex JJ (informative) Using a functional tester to assess pulse oximeter equipment
53 conditions of signal inadequacy over a range of transmitted light and optical
54 modulation . 117
55 Annex KK (informative) Using a transfer standard in pulse oximeter equipment
56 development . 121
57 Annex LL (informative) Reference to the IMDRF essential principles and
58 labelling guidances . 126
60 Figure 201.101 — Example finger pulse oximeter probe locations and orientation . 22
61 Figure 201.102 — Dorsal distal phalanx location . 34
62 Figure AA.1 — Example graph of the subject mean biases versus ITA . 58
63 Figure AA.2 — Probability of obtaining an observed A for fingerclip vs reference
rms
64 CO-oximeter less than or equal to 3,0, as a function of the true A , by sample size . 61
rms
65 Figure AA.3 — Comparison of sample size for two ranges of SaO2 to determine
66 the effects on sample size . 62
67 Figure CC.1 — Synthesized calibration data (base case) . 80
68 Figure CC.2 — Constant offset has been added to base case. 81
69 Figure CC.3 — Tilt has been added to base case . 82
70 Figure CC.4 — Graphical representation for the definition of local bias
71 (Test pulse oximeter probe SpO as a function of reference S ) . 83
R
72 Figure CC.5 — Graphical representation for the definition of local bias and mean bias
73 (Test probe SpO as a function of reference S ) . 84
R
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74 Figure EE.1 — Example of desaturation-time profile . 93

75 Figure FF.1 — Sample calibration curve for pulse oximeter equipment . 99
76 Figure FF.2 — Interface of a functional tester that uses a photodiode and LED
77 to interact with a pulse oximeter probe . 101
78 Figure FF.3 — Interface of a functional tester that uses a dye mixture . 102
79 Figure FF.4 — Interface of a functional tester that uses a liquid crystal modulator . 102
80 Figure FF.5 — Absorbency of blue bandage material (measured in reflection) used in a
81 special test pulse oximeter probe with great patient-to-patient variability
82 of calibration . 104
83 Figure FF.6 — Calibration of high-variability pulse oximeter probe
84 in a controlled desaturation study on five test participants . 105
85 Figure GG.1 — Illustration of fidelity of pulse oximeter equipment performance
86 in tracking saturation changes . 107
87 Figure GG.2 — Illustration of effect of different averaging times on fidelity . 107
88 Figure GG.3 — Graphic representation of components of alarm system delay . 108
89 Figure GG.4 — Illustration of the effects of different averaging times
90 on a more rapid and noisier desaturation signal . 109
91 Figure KK.1 — Distribution of root mean square error of SpO . 124
93 Table 201.101 — Distributed essential performance requirements . 18
94 Table 201.C.101 — Marking on the outside of pulse oximeter equipment
95 or its parts or accessories . 48
96 Table 201.C.102 — Accompanying documents, general . 49
97 Table 201.C.103 — Accompanying documents, instructions for use . 49
98 Table 201.C.104 — Accompanying documents, technical description . 51
99 Table 201.D.1.101 — Additional symbols on marking . 52
100 Table AA.1 — Probability of detection per sample size . 60
101 Table AA.2 — Qualitative assessment of pulse oximeter equipment shock and
102 vibration environment . 70
103 Table BB.1 — Pulse oximeter probe safe application time and source . 77
104 Table EE.1 — Example of target plateaus and ranges . 93
105 Table HH.1 — Parameters and units of measurement . 111
106 Table HH.2 — Equipment identification . 112
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107 Table HH.3 — Operator-adjustable equipment settings . 112

108 Table HH.4 — Equipment configuration . 113
109 Table HH.5 — Equipment specifications . 114
110 Table HH.6 — Service monitoring indicators . 114
111 Table HH.7 — External device information . 115
112 Table JJ.1 — Results following the outlined testing procedure . 119
113 Table JJ.2 — Categorization of the observations shown in Table JJ.1 . 119
114 Table JJ.3 — Categorization of the observations shown in Table JJ.2
115 using a deviation threshold of ±4 digits . 120
116 Table KK.1 — Quantiles of RMS values from bootstrap samples of size 30
117 (10 dark / 20 light skinned) . 124
118 Table LL.1 — Correspondence between this document and the essential principles. 126
119 Table LL.2 — Correspondence between this document and the labelling principles . 127
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
122 Foreword
123 ISO (the International Organization for Standardization) is a worldwide federation of national standards
124 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
125 through ISO technical committee. Each member body interested in a subject for which a technical
126 committee has been established has the right to be represented on that committee. International
127 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
128 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
129 electrotechnical standardization.
130 The procedures used to develop this document and those intended for its further maintenance are
131 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
132 different types of ISO documents should be noted. This document was drafted in accordance with the
133 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
134 Attention is drawn to the possibility that some of the elements of this document may be the subject of
135 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
136 patent rights identified during the development of the document will be in the Introduction and/or on
137 the ISO list of patent declarations received (see www.iso.org/patents).
138 Any trade name used in this document is information given for the convenience of users and does not
139 constitute an endorsement.
140 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
141 expressions related to conformity assessment, as well as information about ISO’s adherence to the World
142 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
143 www.iso.org/iso/foreword.html.
144 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
145 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care and
146 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D, Electric
147 equipment, in collaboration with the European Committee for Standardization (CEN) Technical
148 Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the Agreement on
149 technical cooperation between ISO and CEN (Vienna Agreement).
150 This third edition cancels and replaces the second edition (ISO 80601-2-61:2018), which has been
151 technically revised.
152 The main changes compared to the previous edition are as follows:
153  alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-8:2006+AMD1:2012
154 +AMD2:2020, IEC 60601-1-2:2014+AMD1:2020 and IEC 60601-1-6:2010+AMD1:2013
155 +AMD2:2020.
156  increased disclosure requirements;
157  increased the required number of participants in the clinical study and their diversity;
158  reduced the maximum permissible A ;
rms
159  required disparate bias determination;
160  clarified that accessories need to be included in the clinical performance verification and conformity
161 to the requirements of the document
162  updated the reporting requirements for the clinical performance verification; and
163  harmonization with ISO 20417, where appropriate.
164 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
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165 Any feedback or questions on this document should be directed to the user’s national standards body. A

166 complete listing of these bodies can be found at www.iso.org/members.html.
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
167 Introduction
168 The approximation of arterial haemoglobin saturation and pulse rate using pulse oximetry is common
169 practice in many areas of medicine. This document covers basic safety and essential performance
170 requirements achievable within the limits of existing technology.
171 The committees recognized the need to revise the first edition of this document because of the publication
172 of the first edition of IEC 60601-1-12, as well as the fourth edition of IEC 60601-1-2, the second edition
173 of IEC 60601-1-11 and the first Amendments to both the third edition of IEC 60601-1, the third edition
174 of IEC 60601-1-6 and the second edition of IEC 60601-1-8.
175 Annex AA contains a rationale for some of the requirements. It is included to provide additional insight
176 into the reasoning of the committees that led to a requirement and identifying the hazards that the
177 requirement addresses.
178 Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the
179 interface between a pulse oximeter probe and a patient’s tissue.
180 Annex CC discusses both the formulae used to evaluate the SpO accuracy of pulse oximeter equipment
181 measurements, and the names that are assigned to those formulae.
182 Annex DD presents guidance on when in vitro blood calibration of pulse oximeter equipment is needed.
183 Annex EE presents a guideline for a controlled desaturation study for the calibration of pulse oximeter
184 equipment.
185 Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry.
186 Annex GG describes concepts of pulse oximeter equipment response time.
187 Annex HH describes data interface requirements.
188 In this document, the following print types are used:
189 – requirements and definitions: roman type;
190 – terms defined in Clause 3 of the IEC 60601-1:2005+AMD1:2012+AMD2:2020 in this document or as
191 noted: italic type; and
192 – informative material appearing outside of tables, such as notes, examples and references: in smaller type;
193 normative text of tables is also in a smaller type.
194 In referring to the structure of this document, the term
195 – “clause” means one of the six numbered divisions within the table of contents, inclusive of all
196 subdivisions (e.g., Clause 201 includes subclauses 201.7.1, 201.7.2) and
197 – “subclause” means a numbered subdivision of a clause (e.g., 201.7.1, 7.2 and 201.7.2.1 are all
198 subclauses of Clause 201.7).
199 References to clauses within this document are preceded by the term “Clause” followed by the clause
200 number. References to subclauses within this document are by number only.
201 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
202 of the conditions is true.
203 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives,
204 Part 2. For the purposes of this document, the auxiliary verb:
205 – “shall” indicates a requirement;
206 – “should” indicates a recommendation;
– “may” indicates a permission;
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208 – “can” indicates a possibility or capability; and

209 – “must” is used express an external constraint.
210 A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
211 Any feedback or questions on this document should be directed to the user’s national standards body. A
212 complete listing of these bodies can be found at www.iso.org/members.html.
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
214 Medical electrical equipment —
216 Part 2-61:
217 Particular requirements for basic safety and essential
218 performance of pulse oximeter equipment
219 201.1 Scope, object, and related standards
220 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
221 201.1.1 Scope
222 Replacement:
223 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
224 This document applies to the basic safety and essential performance of pulse oximeter equipment
225 intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary
226 for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
227 These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse
228 oximeter probes and probe cable extenders regardless of their origin (i.e., including remanufactured
229 products).
230 The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial
231 oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as
232 well as patients in the home healthcare environment and the emergency medical services environment.
233 This document is not applicable to pulse oximeter equipment intended for use in laboratory research
234 applications nor to oximeters that require a blood sample from the patient.
235 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME
236 systems only, the title and content of that clause or subclause will say so. If that is not the case, the
237 clause or subclause applies both to ME equipment and to ME systems, as relevant.
238 Hazards inherent in the intended physiological function of ME equipment or ME systems within the
239 scope of this document are not covered by specific requirements in this document except in 201.11
240 and in 7.2.13 and IEC 60601-1:2005+AMD1:2012+AMD2:2020, 8.4.1.
241 NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
242 This document can also be applied to ME equipment and their accessories used for compensation or
243 alleviation of disease, injury, or disability.
244 This document is not applicable to pulse oximeter equipment intended solely for foetal use.
245 This document is not applicable to remote or slave (secondary) equipment that displays SpO values
246 that are located outside of the patient environment.
247 NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to
248 meet the requirements of the appropriate document when configured for that function.
249 This document is applicable to pulse oximeter equipment intended for use under extreme or
250 uncontrolled environmental conditions outside the hospital environment or physician’s office, such
251 as in ambulances and air transport. Additional standards can apply pulse oximeter equipment for
252 those environments of use.
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253 This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.

254 201.1.2 Object
255 Replacement:
256 The object of this document is to establish particular basic safety and essential performance
257 requirements for pulse oximeter equipment [as defined in 201.3.254] and its accessories.
258 NOTE 1 Accessories are included because the combination of the pulse oximeter monitor and the accessories
259 needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential
260 performance of pulse oximeter equipment.
[25] [26]
261 NOTE 2 This document has been prepared to address the relevant essential principles and labelling
262 guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex LL.
263 NOTE 3 This document has been prepared to address the relevant general safety and performance
[27]
264 requirements of European regulation (EU) 2017/745 .
265 201.1.3 Collateral standards
266 Amendment (add after existing text):
267 This document refers to those applicable collateral standards that are listed in
268 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 and Clause 201.2 of this document.
269 IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
270 IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11+AMD1:2020 and
271 IEC 60601-1-12+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212, respectively.
272 IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series
273 apply as published.
274 201.1.4 Particular standards
275 Replacement:
276 In the IEC 60601 series, particular standards may modify, replace, or delete requirements contained
277 in the general standard, including the collateral standards, as appropriate for the particular
278 ME equipment under consideration, and may add other basic safety or essential performance
279 requirements.
280 NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
281 A requirement of a particular standard takes priority over the general standard or the collateral
282 standards.
283 For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the
284 general standard. Collateral standards are referred to by their document number.
285 The numbering of clauses and subclauses of this document corresponds to those of the general
286 standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the
287 general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits
288 of the collateral standard document number (e.g. 202.4 in this document addresses the content of
289 Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of
290 Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of the general
291 standard are specified by the use of the following abbreviated words:
292 "Replacement" means that the clause or subclause of the general standard or applicable collateral
293 standard is replaced completely by the text of this document.
294 "Addition" means that the text of this document is additional to the requirements of the general
295 standard or applicable collateral standard.
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296 "Amendment" means that the clause or subclause of the general standard or applicable collateral

297 standard is amended as indicated by the text of this document.
298 Subclauses or figures that are additional to those of the general standard are numbered starting from
299 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
300 Subclauses or figures that are additional to those of a collateral standard are numbered starting from
301 2xx, where “x” is the number of the collateral standard (e.g., 202 for IEC 60601-1-2, 203 for
302 IEC 60601-1-3, etc).
303 The term "this document" is used to make reference to the general standard, any applicable collateral
304 standards and this particular document taken together.
305 Where there is no corresponding clause or subclause in this document, the section, clause or
306 subclause of the general standard or applicable collateral standard, although possibly not relevant,
307 applies without modification; where it is intended that any part of the general standard or applicable
308 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given
309 in this particular document.
310 201.2 Normative references
311 The following documents are referred to in the text in such a way that some or all of their content
312 constitutes requirements of this document. For dated references, only the edition cited applies. For
313 undated references, the latest edition of the referenced document (including any amendments)
314 applies.
315 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
316 extent (in whole or in part) to which they apply.
317 NOTE 2 Informative references are listed in the Bibliography.
318 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
319 –Addition:
320 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise
321 sources using sound pressure — Engineering methods for an essentially free field over a reflecting plane
322 ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice
323 ISO 14937:2009, Sterilization of health care products — General requirements for characterization of
324 a sterilizing agent and the development, validation and routine control of a sterilization process for
325 medical devices
326 ISO 15223-1:2021, Medical devices — Symbols to be used with medical device labels, labelling and
327 information to be supplied — Part 1: General requirements
328 ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
329 IEC 60068-2-27:2008, Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
330 IEC 60068-2-31:2008, Environmental testing — Part 2-31: Tests — Test Ec: Rough handling shocks,
331 primarily for equipment-type specimens
332 IEC 60068-2-64:2008+AMD1:2019, Environmental testing — Part 2-64: Tests — Test Fh: Vibration,
333 broadband random and guidance
334 IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment — Part 1-11: General requirements
335 for basic safety and essential performance — Collateral Standard: Requirements for medical electrical
336 equipment and medical electrical systems used in the home healthcare environment
337 IEC 60601-1-12:2014+AMD1:2020, Medical electrical equipment — Part 1-12: General requirements
338 for basic safety and essential performance — Collateral Standard: Requirements for medical electrical
339 equipment and medical electrical systems used in the emergency medical services environment
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340 IEC 60825-2:2021, Safety of laser products — Part 2: Safety of optical fibre communication systems

341 (OFCS)
342 IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to
343 medical devices
344 201.3 Terms and definitions
345 For the purposes of this document, the terms and definitions given in
346 IEC 60601-1:2005+AMD 1:2012+AMD1:2020, and the following apply.
347 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
348  ISO Online browsing platform: available at http://www.iso.org/obp
349  IEC Electropedia: available at http://www.electropedia.org/
350 NOTE An alphabetized index of defined terms is found following the Bibliography.
351 201.3.201
352 accompanying information
353 information accompanying or marked on a medical device or accessory for the user or those
354 accountable for the installation, use, processing, maintenance, decommissioning and disposal of the
355 medical device or accessory, particularly regarding safe use
356 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
357 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
358 description, installation manual, quick reference guide, etc.
359 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
360 auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB drive, website).
361 [SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
362 201.3.202
363 accuracy
364 closeness of agreement between a test result and an accepted reference value
365 Note 1 to entry: Subclause 201.12.1.101.2 provides the method of calculating the SpO2 accuracy of pulse
366 oximeter equipment.
367 Note 2 to entry: Additional information is found in Annex CC.
368 [SOURCE: ISO 3534-2:2006, 3.3.1, modified — Replaced note 1 to note 3 with new notes and ‘or
369 measurement result and the true’ with ‘and an accepted reference ’.]
370 201.3.203
371 alarm condition delay
372 time from the occurrence of a triggering event either in the patient, for physiological alarm conditions,
373 or in the equipment, for technical alarm conditions, to when the alarm system determines that an
374 alarm condition exists
375 [SOURCE: IEC 60601-1-8:2006, 3.2]
376 201.3.204
377 alarm limit
378 threshold used by an alarm system to determine an alarm condition
379 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.3]
4 © ISO 2024 – All rights reserved

ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
380 201.3.205
381 alarm paused
382 state of limited duration in which the alarm system or part of the alarm system does not generate
383 alarm signals
384 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.5]
385 201.3.206
386 alarm preset
387 set of stored configuration parameters, including selection of algorithms and initial values for use by
388 algorithms, which affect or modify the performance of the alarm system
389 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.6]
390 201.3.207
391 alarm signal generation delay
392 time from the onset of an alarm condition to the generation of its alarm signal(s)
393 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.10
394 201.3.208
395 audio paused
396 state of limited duration in which the alarm system or part of the alarm system does not generate an
397 auditory alarm signal
398 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.13]
399 201.3.209
400 colour measurement site
401 location on the body at which the skin pigmentation is assessed by pigmentation measurement
402 methods (PMMs)
403 201.3.210
404 controlled desaturation study
405 hypoxaemia induced in a group of healthy adult human participants performed under well controlled,
406 optimal or non-optimal laboratory conditions.
407 201.3.211
408 CO-oximeter
409 multiwavelength optical blood analyser that measures total haemoglobin concentration and the
410 concentrations of various haemoglobin derivatives
411 Note 1 to entry: The relevant CO-oximetry value is functional saturation of arterial blood, SaO , which pulse
412 oximeter equipment estimates and reports as SpO .
413 201.3.212
414 data update period
415 interval in which the pulse oximeter equipment algorithm provides new valid data to the display or
416 the functional connection
417 Note 1 to entry: This definition does not refer to the regular refresh period of the display, which is typically on
418 the order of 1 s, but rather to the (typically longer) interval defined above.
419 201.3.213
420 declared range
421 portion of the displayed range of SpO and pulse rate values over which there is specified accuracy
ISO/DIS 80601-2-61:2024(en)
ISO 80601-2-61:2024(E)
422 201.3.214
423 default alarm preset
alarm preset
424 that can be activated by the alarm system without operator action
425 Note 1 to entry: Manufacturer- or responsible organization-configured alarm presets are possible types of
426 default alarm presets.
427 [SOURCE: IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, 3.16]
428 201.3.215
429 disparate bias
430 bias that is meaningfully different when comparing between levels
431 Note 1 to entry: Disparate bias refers to a bias attributed to difference in SpO due to skin pigmentation, which
432 is too great. Disparate bias is assessed across pigmentation levels. See 201.12.1.101.6 h).
433 201.3.216
434 displayed range
435 range of SpO or pulse rate values that can be displayed by the pulse oximeter equipment
436 Note 1 to entry: The displayed range can extend beyond the declared range.
437 201.3.217
438 distributed alarm system
439 DAS
440 alarm system that involves more than one item of equipment of a ME system intended for delivery of
441 alarm conditions with technical confirmation
442 Note 1 to entry: The parts of a distributed alarm system can be widely separated in distance.
443 Note 2 to entry: A distributed alarm system is intended to notify operators of the existence of an alarm
444 condition.
445 Note 3 to entry: For the purposes of this document, technical confirmation means that each element of a
446 distributed alarm system confirms or guarantees the successful delivery of the alarm condition to the next
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