prEN ISO 12487

SLOVENSKI STANDARD
01-februar-2025
Medicinska električna oprema - Klinično vrednotenje učinkovitosti kliničnih
termometrov (ISO/DIS 12487:2024)
Medical electrical equipment - Clinical performance evaluation of clinical thermometers
(ISO/DIS 12487:2024)
Medizinische elektrische Geräte - Prüfung der klinischen Leistung von medizinischen
Thermometern (ISO/DIS 12487:2024)
Équipement respiratoire - Investigation clinique des thermomètres cliniques (ISO/DIS
12487:2024)
Ta slovenski standard je istoveten z: prEN ISO 12487
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 12487
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Clinical performance evaluation of
Voting begins on:
clinical thermometers
2024-12-03
ICS: 11.040.55
Voting terminates on:
2025-02-25
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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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 12487:2024(en)
DRAFT
ISO/DIS 12487:2024(en)
International
Standard
ISO/DIS 12487
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Clinical performance evaluation of
Voting begins on:
clinical thermometers
ICS: 11.040.55
Voting terminates on:
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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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TO SUBMIT, WITH THEIR COMMENTS,
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 12487:2024(en)
ii
ISO/DIS 12487:2024(en)
1 Contents Page
2 1 Scope . 1
3 2 Normative references . 1
4 3 Terms and definitions . 1
5 4 General requirements . 7
6 4.1 Clinical investigation methods . 7
7 4.2 Good clinical practice . 7
8 4.3 Status of previous clinical investigations . 8
9 4.4 Disclosure of summary of clinical investigation . 8
10 5 Clinical investigation . 8
11 5.1 Subject requirements . 8
12 5.1.1 Number . 8
13 5.1.2 Age distribution . 8
14 5.1.3 Body temperature distribution . 9
15 5.1.4 Indicated reference site . 9
16 5.1.5 Exception criteria . 10
17 5.2 Clinical investigation method with a reference site thermometer . 10
18 5.2.1 Environmental condition of clinical investigation . 10
19 5.2.2 Subject preparation for body temperature stabilization . 10
20 5.2.3 Reference site thermometer measurement . 11
21 5.2.4 Clinical thermometer-under-test measurement . 11
22 5.3 Procedure . 12
23 5.3.1 Clinical thermometers with time prediction . 12
24 5.3.2 Clinical thermometers with site conversion . 12
25 6 Data analysis . 13
26 6.1 Correction of the readings of the reference site thermometer . 13
27 6.2 Clinical bias calculation . 13
28 6.3 Standard deviation of the clinical bias calculation . 14
29 6.4 Clinical repeatability calculation . 14
30 7 Acceptance criteria . 15
31 7.1 Clinical bias . 15
32 7.2 Standard deviation of the clinical bias . 15
33 7.3 Clinical repeatability . 15
34 Annex A (informative) Particular guidance and rationale . 16
35 A.1 General guidance . 16
36 A.2 Rationale for particular clauses and subclauses . 16
37 Annex B (informative) Terminology — alphabetized index of defined terms . 22
38 Bibliography . 24
iii
ISO/DIS 12487:2024(en)
Foreword
41 ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
42 Commission) form the specialized system for worldwide standardization. National bodies that are
43 members of ISO or IEC participate in the development of International Standards through technical
44 committees established by the respective organization to deal with particular fields of technical activity.
45 ISO and IEC technical committees collaborate in fields of mutual interest. Other international
46 organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
47 work. In the field of information technology, ISO and IEC have established a joint technical committee,
48 ISO/IEC JTC 1.
49 The procedures used to develop this document and those intended for its further maintenance are
50 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
51 different types of document should be noted. This document was drafted in accordance with the editorial
52 rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
53 Attention is drawn to the possibility that some of the elements of this document may be the subject of
54 patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details
55 of any patent rights identified during the development of the document will be in the Introduction and/or
56 on the ISO list of patent declarations received (see www.iso.org/patents).
57 Any trade name used in this document is information given for the convenience of users and does not
58 constitute an endorsement.
59 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
60 expressions related to conformity assessment, as well as information about ISO's adherence to the World
61 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
62 www.iso.org/iso/foreword.html.
63 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
64 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
65 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62D,
66 Electromedical equipment in collaboration with the European Committee for Standardization (CEN)
67 Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
68 technical cooperation between ISO and CEN (Vienna Agreement).
69 This first edition of ISO 12487 together with the third edition of ISO 80601-2-56, cancels and replaces the
70 second edition of ISO 80601-2-56 published in 2017 and its Amendment 1 (2019).
71 Any feedback or questions on this document should be directed to the user’s national standards body. A
72 complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 12487:2024(en)
Introduction
73 Determining body temperature is an important procedure that is clinically used to assess the status of
74 patients as well as blood pressure, SpO and pulse rate. This document is intended to provide the
75 necessary requirements for the clinical investigation to ensure that the essential performance of these
76 clinical thermometers is at an adequate level.
77 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
78 In this document, the following print types are used.
79 — Requirements and definitions: roman type.
80 — Terms defined in clause 3 of this document or as noted: italic type.
81 — Informative material appearing outside of tables, such as notes, examples and references: in smaller
82 type. Normative text of tables is also in a smaller type.
83 In referring to the structure of this document, the term
84 — “clause” means one of the numbered divisions within the table of contents, inclusive of all
85 subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), and
86 — “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses
87 of Clause 7).
88 References to clauses within this document are preceded by the term “Clause” followed by the clause
89 number. References to subclauses within this particular document are by number only.
90 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
91 of the conditions is true.
92 In this document, the following verbal forms are used:
93 — “shall” indicates a requirement;
94 — “should” indicates a recommendation;
95 — “may” indicates a permission;
96 — "can" is used to describe a possibility or capability; and
97 — "must" is used to indicate an external constraint.
v
DRAFT INTERNATIONAL STANDARD ISO/DIS 12487:2024(e)
100 Medical electrical equipment — Clinical performance
101 evaluation of clinical thermometers
102 1 Scope
103 This document specifies the requirements and methods for the clinical investigation of ME equipment
104 used to measure the body temperature in indirect measurement mode.
105 This document covers both intermittently and continuously measuring clinical thermometers.
106 This document is not intended for clinical thermometers measuring the body temperature in direct
107 measurement mode.
108 NOTE 1 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance
109 with IEC 80601-2-56 is considered sufficient.
110 NOTE 2 For clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such
111 as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement) are treated
112 as predictive type thermometers and fall under the scope of this document.
113 This document specifies additional disclosure requirements.
114 This document is not applicable to the clinical investigation of a screening thermographs for human
115 febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
116 2 Normative references
117 The following documents are referred to in the text in such a way that some or all of their content
118 constitutes requirements of this document. For dated references, only the edition cited applies. For
119 undated references, the latest edition of the referenced document (including any amendments) applies.
120 ISO 80601-2-56:— , Medical electrical equipment — Part 2-56: Particular requirements for basic safety
121 and essential performance of clinical thermometers for body temperature measurement
122 ISO 14155:— , Clinical investigation of medical devices for human subjects — Good clinical practice
123 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
124 requirements for basic safety and essential performance +Amendment 1:2012 +Amendment 2:2020
125 JCGM 100:2008, Evaluation of measurement data — Guide to the expression of uncertainty in
126 measurement (GUM 1995 with minor corrections)
127 3 Terms and definitions
128 For the purposes of this document, the following terms and definitions apply.
Under preparation. Stage at the time of publication: ISO/DIS 80601-2-56:2024.
Under preparation. Stage at the time of publication: ISO/DIS 14155:2024.
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
129 ISO and IEC maintain terminological databases for use in standardization at the following addresses:

130  ISO Online browsing platform: available at http://www.iso.org/obp
131  IEC Electropedia: available at http://www.electropedia.org/
132 3.1
133 accompanying information
134 information accompanying or marked on a medical device or accessory for the user or those accountable
135 for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or
136 accessory, particularly regarding safe use
137 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
138 Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
139 description, installation manual, quick reference guide, etc.
140 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
141 auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).
142 [SOURCE: ISO 20417:2021, 3.2, modified — deleted note 4.]
143 3.2
144 clinical accuracy
145 closeness of agreement between the output temperature of a clinical thermometer and the reference value
146 of the temperature of the reference site that the clinical thermometer purports to represent
147 [SOURCE: ISO 80601-2-56:—, 201.3.202]
148 3.3
149 clinical bias
150 Δ
cb
151 mean difference between output temperatures of a clinical thermometer and a reference thermometer for
152 the intended reference body site
153 Note 1 to entry: The measuring site can be the same as or different from the reference body site.
154 3.4
155 clinical investigation
156 systematic investigation in one or more human subjects, undertaken to assess the clinical performance,
157 effectiveness or safety of a medical device
158 Note 1 to entry: For the purpose of this document, “clinical trial” or “clinical study” are synonymous with “clinical
159 investigation”.
160 [SOURCE: ISO 14155:—, 3.9]
161 3.5
162 clinical investigation report
163 document describing the design, conduct, statistical analysis and results of a clinical investigation
164 [SOURCE: ISO 14155:—, 3.11]
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
165 3.6
166 clinical repeatability
167 σ
repeat
168 pooled standard deviation (over a selected group of subjects) of changes in multiple output temperatures
169 taken from the same subject at the same measuring site with the same clinical thermometer by the same
170 operator within a relatively short time
171 [SOURCE: ASTM 1965-98, 3.2.10, modified — focus changed from “ear canal temperature” to the more
172 general “measuring site” and the parenthetical part “(over a selected group of subjects)” was included.]
173 3.7
174 clinical thermometer
175 ME equipment used for measuring at the measuring site and indicating the temperature at the reference
176 site
177 Note 1 to entry: The measuring site can be the same as the reference site.
178 [SOURCE: ISO 80601-2-56:—, 201.3.203]
179 3.8
180 clinical thermometer-under-test
181 DUT
182 clinical thermometer undergoing clinical investigation
183 3.9
184 direct measurement mode
185 operating mode of a clinical thermometer where the output temperature represents the temperature of
186 the measuring site with which the probe is in thermal equilibrium
187 [SOURCE: ISO 80601-2-56:—, 201.3.204]
188 3.10
189 essential performance
190 performance of a clinical function, other than that related to basic safety, where loss or degradation
191 beyond the limits specified by the manufacturer results in an unacceptable risk
192 Note 1 to entry: Essential performance is most easily understood by considering whether its absence or degradation
193 would result in an unacceptable risk.
194 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.27]
195 3.11
196 indicated body site
197 body site of a subject to which the output temperature relates
198 Note 1 to entry: There is guidance or rationale for this definition contained in Clause AA.2.
199 3.12
200 indirect measurement mode
201 operating mode of a clinical thermometer where the output temperature represents the temperature of a
202 measuring site with which the probe is not in thermal equilibrium
203 Note 1 to entry: Infrared clinical thermometers are not typically in thermal equilibrium with the measuring site and
204 are therefore typically in indirect measurement mode.
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
205 [SOURCE: ISO 80601-2-56:—, 201.3.207]

206 3.13
207 instructions for use
208 portion of the accompanying information that is essential for the safe and effective use of a medical device
209 or accessory directed to the user of the medical device
210 [SOURCE: ISO 20417:2021, 3.11, modified — deleted notes.]
211 3.14
212 laboratory accuracy
213 closeness of agreement between the output temperature of a clinical thermometer and a reference
214 thermometer
215 Note 1 to entry: Laboratory accuracy is sometimes referred to as maximum permissible error.
216 [SOURCE: ISO 80601-2-56:—, 201.3.208]
217 3.15
218 manufacturer
219 natural or legal person with responsibility for the design, manufacture, packaging, or labelling of
220 ME equipment, assembling an ME system, or adapting ME equipment or an ME system, regardless of
221 whether these operations are performed by that person or on his behalf by another person(s)
222 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.55, modified — replaced “his” with “their” and
223 deleted notes.]
224 3.16
225 measuring site
226 part of a patient where the temperature is measured
227 EXAMPLE Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla
228 (armpit), forehead skin.
229 [SOURCE: ISO 80601-2-56:—, 201.3.209]
230 3.17
231 medical electrical equipment
232 ME equipment
233 electrical equipment having an applied part or transferring energy to or from the patient or detecting
234 such energy transfer to or from the patient and which is:
235 a) provided with not more than one connection to a particular supply mains; and
236 b) intended by its manufacturer to be used:
237   1) in the diagnosis, treatment, or monitoring of a patient; or
238   2) for compensation or alleviation of disease, injury or disability
239 Note 1 to entry: ME equipment includes those accessories as defined by the manufacturer that are necessary to
240 enable the normal use of the ME equipment.
241 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.63, modified —deleted notes 2 to 5.]
242 3.18
243 operator
244 person handling equipment
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
245 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.73, modified —deleted note.]
246 3.19
247 output temperature
248 temperature indicated by a clinical thermometer
249 Note 1 to entry: Methods of indication can include printed, spoken, displayed and remotely displayed.
250 [SOURCE: ISO 80601-2-56:—, 201.3.212]
251 3.20
252 patient
253 living being (person or animal) undergoing a medical, surgical or dental procedure
254 Note 1 to entry: A patient can be an operator.
255 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.76]
256 3.21
257 probe
258 part of a clinical thermometer that provides a thermal coupling between the sensor and the patient
259 Note 1 to entry: Thermal coupling can be contact or non-contact.
260 [SOURCE: ISO 80601-2-56:—, 201.3.213]
261 3.22
262 probe cover
263 disposable or reusable accessory of a clinical thermometer that provides a sanitary barrier between the
264 probe and the patient
265 [SOURCE: ISO 80601-2-56:—, 201.3.215]
266 3.23
267 procedure
268 specified way to carry out an activity or a process
269 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.88]
270 3.24
271 process
272 set of interrelated or interacting activities that use inputs to deliver an intended result
273 Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the
274 context of the reference.
275 Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally
276 the inputs to other processes.
277 Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.
278 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.89.]
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
279 3.25
280 rated
281 term referring to a value assigned by the manufacturer for a specified operating condition
282 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.97]
283 3.26
284 reference site thermometer
285 RST
286 thermometer measuring at the reference body site in direct measurement mode and having established
287 laboratory accuracy
288 3.27
289 reference thermometer
290 equilibrium thermometer of a contact type for laboratory application whose calibration is traceable to a
291 national standard of temperature, with a specified accuracy and associated uncertainty
292 [SOURCE: ISO 80601-2-56:—, 201.3.217]
293 3.28
294 risk
295 combination of the probability of occurrence of harm and the severity of that harm
296 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.102]
297 3.29
298 sensor
299 part of the clinical thermometer that converts thermal energy into an electrical signal
300 [SOURCE: ISO 80601-2-56:—, 201.3.218]
301 3.30
302 site conversion
303 process of measuring temperature at a measurement site and converting the value to another site
304 [SOURCE: ISO 80601-2-56:—, 201.3.219]
305 3.31
306 test mode
307 state of a clinical thermometer where the output temperature represents the temperature measured by
308 the sensor and does not include site conversion or time prediction
309 Note 1 to entry: The test mode is used for the determination of the laboratory accuracy of the clinical thermometer.
310 Note 2 to entry: The test mode does not necessarily need to be an additional mode and may be the direct
311 measurement mode of the clinical thermometer.
312 [SOURCE: ISO 80601-2-56:—, 201.3.221]
313 3.32
314 thermal equilibrium
315 measurement status after which the further output temperature change is < 0,1°C/16 seconds (example
316 for methods such as oral or rectal measurement)
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
317 3.33
318 time prediction
319 process of predicting the temperature of a measurement site before thermal equilibrium has been reached
320 [SOURCE: ISO 80601-2-56:—, 201.3.222]
321 3.34
322 type test
323 test on a representative sample of the equipment with the objective of determining if the equipment, as
324 designed and manufactured, can meet the requirements of this document
325 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.135]
326 3.35
327 verification
328 confirmation through the provision of objective evidence that specified requirements have been fulfilled
329 Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms
330 of determination such as performing alternative calculations or reviewing documents.
331 Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.
332 Note 3 to entry: The term “verified” is used to designate the corresponding status.
333 [SOURCE: ISO 60601-1:2005+AMD1:2012+AMD2:2020, 3.138]
334 4 General requirements
335 NOTE There is guidance or rationale for this Clause contained in Clause AA.2.
336 4.1 Clinical investigation methods
337 a) Clinical thermometers in indirect measurement mode, and direct measurement mode clinical
338 thermometers with a measurement time shorter than or equal to 60 s (for methods such as oral or
339 rectal measurement) or shorter than or equal to 5 min (for methods such as axillary measurement)
340 shall undergo clinical investigation according to this document.
341 b) The clinical investigation shall be considered a type test.
342 NOTE The representative sample used for this type test can consist of one or multiple clinical
343 thermometers.
344 c) Unless otherwise specified in this document, the manufacturer shall consider:
345 1) the sequential method when the physical interference between the probes of the clinical
346 thermometer and the reference site thermometer is concerned.
347 2) the simultaneous method when the temperature variation between measurements is concerned.
348 Check conformity by inspection of the clinical investigation report.
349 4.2 Good clinical practice
350 a) All clinical investigations shall comply with the requirements of ISO 14155:—.
ISO/DIS 12487:2024(en)
ISO DIS 12487:2024(E)
351 b) Clinical investigation with invasive reference body site or invasive measuring site should not be used

352 for patients or subjects solely for the purpose of investigating clinical thermometer performance.
353 NOTE Some authorities having jurisdiction have additional requirements.
354 c) The requirements of this document, which are more specific than the corresponding requirements
355 of ISO 14155:—, shall prevail.
356 Check conformity by application of the requirements of ISO 14155:—.
357 4.3 Status of previous clinical investigations
358 The clinical investigation results for clinical thermometers that have been successfully clinically
359 investigated according to previous versions of ISO 80601-2-56:
360 a) remain valid; and
361 b) a clinical investigation need not be repeated to comply with this document.
362 4.4
...