（高清正版）ISO 12487-2026 医用电气设备——临床体温计的临床性能评估

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Medical electrical equipment—

Clinical performance evaluation of

clinical thermometers

Appareils électromédicaux—Evaluation de la performance

clinique des thermometres médicaux

Reference number

ISO 12487:2026(en)

International

Standard

ISO 12487

First edition

2026-05

◎ISO 2026

iii

ISO12487:2026(en)

Contents Page

Foreword..................................................................................................................................................................... iv

Introduction............................................................................................................................................................... V

1 Scope ............................................................................................................................................................... 1

2 Normative references ...................................................................................................................................

3 Terms and definitions ..................................................................................................................................

4 General requirements................................................................................................................................... 7

4.1 Clinical investigation methods ..........................................................................................................

4.2 Good clinical practice..........................................................................................................................

4.3 Status of previous clinical investigations............................................................................................

4.4 Disclosure of summary of clinical investigation ...............................................................................

5 Clinical investigation ...................................................................................................................................

5.1 Subject requirements............................................................................................................................

5.1.1 Number................................................................................................................................... 8

5.1.2 Age distribution...................................................................................................................... 8

5.1.3 Body temperature distribution..............................................................................................9

5.1.4 Body site for clinical investigation.......................................................................................... 9

5.1.5 Exception criteria ............................................................................................................... 10

5.2 Clinical investigation method with a reference thermometer ........................................................

5.2.1 Environmental condition of clinical investigation................................................................10

5.2.2 Subject preparation for body temperature stabilization .................................................. 10

5.2.3 Reference thermometer measurement ............................................................................ 11

5.2.4 Clinical thermometer-under-test ....................................................................................... 11

5.3 Procedure

....................................................................................................................................... 11

5.3.1 Clinical thermometers with time prediction ....................................................................... 12

5.3.2 Clinical thermometers with site conversion ..................................................................... 12

6 Data analysis ............................................................................................................................................... 13

6.1 Correction of the readings ofthe reference thermometer............................................................. 13

6.2 Clinical bias calculation ................................................................................................................... 13

6.3 Standard deviation of the clinical bias calculation......................................................................... 14

6.4 Clinical repeatability calculation .................................................................................................... 14

7Acceptance criteria ...................................................................................................................................14

7.1 Clinical bias....................................................................................................................................... 14

7.2 Standard deviation of the clinical bias........................................................................................... 15

7.3 Clinical repeatability .....................................................................................................................

AnnexA(informative) Particular guidance and rationale.............................................................................. 16

Annex B(informative) Guide to disclosure requirements............................................................................... 2

Annex C(informative) Terminology—alphabetized index of defined terms.......................................... 23

Bibliography............................................................................................................................................................... 25

ISO12487:2026(en)

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 partin the work.ISO collaborates closely

with the International Electrotechnical Commission(IEC)onall matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described

in the ISO/IEC Directives,Part 1.In particular,the different approval criteria needed for the different types

of ISO document should be noted.This document was drafted in accordance with the editorial rules of the

ISO/IEC Directives,Part 2(see www.iso.org/directives ).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a)

patent(s).ISO takes no position concerning the evidence,validity or applicability of any claimed patent

rights in respect thereof.As of the date of publication of this document,ISO had not received notice of (a)

patent(s)which may be required to implement this document.However,implementers are cautioned that

this may not represent the latest information,which may be obtained from the patent database available at

www.iso.org/patents .ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions

related to conformity assessment,as well as information about ISO's adherence to the World Trade

Organization(WTO)principles in the Technical Barriers to Trade(TBT),see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,

Subcommittee SC 3,Respiratory devices and related equipment usedfor patient care,and Technical Committee

IEC/TC 62, Medical equipment,software,and systems, Subcommittee SC 62D, Particular medical equipment,

software, and systems, in collaboration with the European Committee for Standardization (CEN)Technical

Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical

cooperation between ISO and CEN (Vienna Agreement).

Any feedback or questions on this document should be directed to the user's national standards body.A

complete listing of these bodies can be found at www.iso.org/members.html.

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标签： #ISO #医用电气设备 #评估

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Medicalelectricalequipment—ClinicalperformanceevaluationofclinicalthermometersAppareilsélectromédicaux—EvaluationdelaperformancecliniquedesthermometresmédicauxReferencenumberISO12487:2026(en)InternationalStandardISO12487Firstedition2026-05◎ISO2026iiiISO12487:2026(en)ContentsPageForeword................

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（高清正版）ISO 12487-2026 医用电气设备——临床体温计的临床性能评估

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