oSIST prEN ISO 12487:2025
(Main)Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)
This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient.
This document specifies additional disclosure requirements.
This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
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)
Medicinska električna oprema - Klinično vrednotenje učinkovitosti kliničnih termometrov (ISO/DIS 12487:2024)
General Information
Standards Content (Sample)
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
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 bod
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.