Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, referred to as ME equipment. ISO 80601-2-56:2017 specifies the general and technical requirements for electrical clinical thermometers. ISO 80601-2-56:2017 applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME systems. ISO 80601-2-56:2017 does not apply to auxiliary equipment. ME equipment that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of ISO 80601-2-56:2017.

Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps

S'applique à tous les équipements électroniques de commande, de régulation, de protection, d'alimentation etc, reliés à la batterie d'accumulateurs du véhicule ou à une source d'alimentation basse tension avec ou sans liaison galvanique avec la ligne de contact. Ne s'applique pas toutefois aux circuits électroniques de puissance qui doivent être conforme à la CEI 61287-1. Couvre les conditions de fonctionnement, la conception, la construction mécanique et les essais des équipements electroniques ainsi que les exigences de base du matériel et logiciel. Annule et remplace les CEI 60571-1, 60571-2, 60571-3.

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Status
Published
Publication Date
21-Mar-2017
Current Stage
PPUB - Publication issued
Completion Date
22-Mar-2017
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INTERNATIONAL ISO
STANDARD 80601-2-56
Second edition
2017-03
Medical electrical equipment —
Part 2-56:
Particular requirements for basic
safety and essential performance
of clinical thermometers for body
temperature measurement
Appareils électromédicaux —
Partie 2-56: Exigences particulières relatives à la sécurité
fondamentale et aux performances essentielles des thermomètres
médicaux pour mesurer la température de corps
Reference number
ISO 80601-2-56:2017(E)
ISO 2017
---------------------- Page: 1 ----------------------
ISO 80601-2-56:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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ii © ISO 2017 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 80601-2-56:2017(E)
Contents Page

Foreword ........................................................................................................................................................................... v

Introduction ................................................................................................................................................................... vi

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 .................................................................................................................................... 7

201.4.2  RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS ............................................................ 7

201.4.3  ESSENTIAL PERFORMANCE .............................................................................................................................. 8

Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements .......................................................... 8

201.5  General requirements for testing of ME EQUIPMENT .............................................................................. 8

201.6  Classification of ME EQUIPMENT and ME SYSTEMS ....................................................................................... 8

201.7  ME EQUIPMENT identification, marking and documents ...................................................................... 8

201.7.9  ACCOMPANYING DOCUMENT ........................................................................................................................... 9

201.8  Protection against electrical HAZARDS from ME EQUIPMENT .............................................................. 10

201.9  Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS ................................. 10

201.10 Protection against unwanted and excessive radiation HAZARDS .................................................. 10

201.11 Protection against excessive temperatures and other HAZARDS .................................................. 11

201.11.7  Biocompatibility of ME EQUIPMENT and ME SYSTEMS ..................................................................... 11

201.12 Accuracy of controls and instruments and protection against hazardous outputs .............. 12

201.12.1  Accuracy of controls and instruments .......................................................................................... 12

201.12.2  Usability ................................................................................................................................................... 12

201.13 HAZARDOUS SITUATIONS and fault conditions.......................................................................................... 12

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................................................. 12

201.15 Construction of ME EQUIPMENT ................................................................................................................... 12

201.16 ME SYSTEMS ....................................................................................................................................................... 13

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .................................................. 13

201.101  Laboratory performance requirements ....................................................................................... 13

201.101.1  * General test requirements ....................................................................................................... 13

201.101.2  * LABORATORY ACCURACY .................................................................................................................. 13

© ISO 2017 – All rights reserved
iii
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ISO 80601-2-56:2017(E)
201.101.3  * Time response for a DIRECT MODE CLINICAL THERMOMETER that is not an

ADJUSTED MODE CLINICAL THERMOMETER ..................................................................................................... 14

201.102  * CLINICAL ACCURACY VALIDATION ......................................................................................................... 15

201.102.1  Method ............................................................................................................................................... 15

201.102.2  * Human subject population requirements .......................................................................... 16

Table 201.102 — Subject age groups .................................................................................................................. 16

201.102.3  * CLINICAL BIAS calculation ............................................................................................................ 17

201.102.4  * LIMITS OF AGREEMENT calculation ............................................................................................. 17

201.102.5  * CLINICAL REPEATABILITY calculation ......................................................................................... 18

201.103  * PROBES, PROBE CABLE EXTENDERS and PROBE COVERS ................................................................... 18

201.103.1  Gen era l ............................................................................................................................................... 18

201.103.2  Labelling ............................................................................................................................................ 19

202  Electromagnetic disturbances — Requirements and tests ........................................................... 19

206  Usability ........................................................................................................................................................... 20

208  General requirements, tests and guidance for alarm systems in medical electrical

equipment and medical electrical systems......................................................................................... 20

211  Requirements for medical electrical equipment and medical electrical systems used

in the home healthcare environment ................................................................................................... 21

212  Requirements for medical electrical equipment and medical electrical systems

intended for use in the emergency medical services environment ........................................... 21

Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and

ME SYSTEMS ........................................................................................................................................................ 22

Annex D (informative) Symbols on marking ................................................................................................. 25

Annex AA (informative) Particular guidance and rationale .................................................................... 27

Figure AA.101 — Example of temperature time adjustment for a predictive intermittent

CLINICAL THERMOMETER .................................................................................................................................. 29

Figure AA.102 — General structure of a CLINICAL THERMOMETER ................................................................. 30

Table AA.101 — Required tests for CLINICAL THERMOMETERS ........................................................................ 33

Table AA.102 — Example combinations of operating conditions and REFERENCE temperature

for testing the LABORATORY ACCURACY ...................................................................................................... 34

Figure AA.103 — Example of a comparison plot for DUT and RCT ............................................................ 36

[18]

Figure AA.104 — Example of a Bland-Altman Plot of the temperature difference (DUT

minus RCT) versus the average OUTPUT TEMPERATURES of two thermometers .......................... 37

Table AA.103 — Example of CLINICAL ACCURACY VALIDATION test results .................................................... 38

Annex BB (informative) Reference temperature source .......................................................................... 40

Annex CC (informative) Reference to the essential principles of safety and performance of

[24]

medical devices in accordance with ISO 16142-1 ....................................................................... 42

Table CC.1 — Correspondence between the essential principles and this document ....................... 42

Annex DD (informative) Terminology — Alphabetized index of defined terms .............................. 45

Bibliography ................................................................................................................................................................. 48

© ISO 2017 – All rights reserved
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ISO 80601-2-56:2017(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.

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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

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

constitute an endorsement.

For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.

This document was prepared by 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, Electrical equipment.

This second edition cancels and replaces the first edition (ISO 80601‐2‐56:2009), which has been

technically revised. It also incorporates the Amendments IEC 60601‐1:2005/AMD1:2012,

IEC 60601‐1‐6:2010/AMD1:2013 and IEC 60601‐1‐8:2006/AMD1:2012, as well as IEC 60601‐1‐12,

the second edition of IEC 60601‐1‐11 and the fourth edition of IEC 60601‐1‐2.
The most significant changes are the following modifications:
— change in the clinical evaluation exclusion criteria related to antipyretics;
[1]
— deletion of Annex CC as this material is covered by IEC 60601‐1‐9 ;
and the following additions:
— disclosure requirement for a summary of the USE SPECIFICATION;
— tests for mechanical strength (via IEC 60601‐1‐11 and IEC 60601‐1‐12);

— tests for ENCLOSURE integrity (water ingress via IEC 60601‐1‐11 and IEC 60601‐1‐12);

— tests for cleaning and disinfection PROCEDURES (via IEC 60601‐1‐11 and IEC 60601‐1‐12).

© ISO 2017 – All rights reserved
---------------------- Page: 5 ----------------------
ISO 80601-2-56:2017(E)
Introduction

This document deals with electrical CLINICAL THERMOMETERS, either already available or that will come

available in the future.

The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The

temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in

combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile, febrile or

hypothermic is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the

PATIENT is ill.

There are different temperatures at each REFERENCE BODY SITE according to the balance between the

[2]

production, transfer, and loss of heat . CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by

comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified

uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL

ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state

between the two thermometers.

For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not

sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the

[3]

characteristics of the PATIENT and the environment . Therefore, the CLINICAL ACCURACY of a CLINICAL

THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods

of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a

specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature.

For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a

DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERATING MODE) with a

sufficiently large group of human subjects.

The intention of this document is to specify the requirements and the test PROCEDURES for the

VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for

the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, 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 DOCUMENT OR AS NOTED: SMALL CAPITALS.

In referring to the structure of this document, the term

— “clause” means one of the numbered divisions within the table of contents, inclusive of all

subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.), and

— “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of

Clause 7).
© ISO 2017 – All rights reserved
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ISO 80601-2-56:2017(E)

References to clauses within this document are preceded by the term “Clause” followed by the clause

number. References to subclauses within this document are by number only.

In this document, 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 document conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this document, the auxiliary verb:

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this

document;

— “should” means that compliance with a requirement or a test is recommended but is not mandatory

for compliance with this document;

— “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.
© ISO 2017 – All rights reserved
vii
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INTERNATIONAL STANDARD ISO 80601-2-56:2017(E)
Medical electrical equipment —
Part 2‐56:
Particular requirements for basic safety and essential
performance of clinical thermometers for body temperature
measurement
201.1 * Scope, object and related standards
IEC 60601‐1:2005+A1:2012, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in

combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This document specifies the

general and technical requirements for electrical CLINICAL THERMOMETERS. This document applies to all

electrical CLINICAL THERMOMETERS that are used for measuring the BODY TEMPERATURE of PATIENTS.

LINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing

equipment, and other auxiliary equipment to create ME SYSTEMS. This document does not apply to

auxiliary equipment.

ME EQUIPMENT that measures a BODY TEMPERATURE is inside the scope of this document.

This document does not specify the requirements for screening thermographs intended to be used for

the individual non‐invasive human febrile temperature screening of groups of individual humans under

[4]
indoor environmental conditions, which are given in IEC 80601‐2‐59 .

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 document are not covered by specific requirements in this document except in

IEC 60601‐1:2005+A1:2012, 7.2.13 and 8.4.1.
NOTE Additional information can be found in IEC 60601–1:2005+A1:2012, 4.2.
201.1.2 Object
Replacement:

The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE

requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the CLINICAL THERMOMETER and the ACCESSORIES

needs to be safe and effective. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL

PERFORMANCE of a CLINICAL THERMOMETER.
© ISO 2017 – All rights reserved
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ISO 80601-2-56:2017(E)
201.1.3 Collateral standards
Addition:

This document refers to those applicable collateral standards that are listed in

IEC 60601‐1:2005+A1:2012, Clause 2, as well as 201.2 of this document.

IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified

[5]

in Clauses 202, 206, 208, 211 and 212, respectively. IEC 60601‐1‐3 does not apply. All other published

collateral standards in the IEC 60601‐1 series apply as published.
201.1.4 Particular standards
Replacement:

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 document takes priority over IEC 60601‐1 and its collateral standards.

For brevity, IEC 60601‐1:2005+A1:2012 is referred to in this document as the general standard.

Collateral standards are referred to by their document number.

The numbering of sections, clauses and subclauses of this document corresponds to that of the general

standard with the prefix “201” (e.g. 201.1 in this document 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 (e.g. 202.4 in this document addresses the content of Clause 4

of the 60601‐1‐2 collateral standard, 203.4 in this document addresses the content of Clause 4 of the

60601‐1‐3 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 IEC 60601‐1 or applicable collateral standard

is replaced completely by the text of this particular document.

“Addition” means that the text of this document is additional to the requirements of the IEC 60601‐1 or

applicable collateral standard.

“Amendment” means that the clause or subclause of the IEC 60601‐1 or applicable collateral standard is

amended as indicated by the text of this document.

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, 203 for

IEC 60601‐1‐3, etc.

The term “this document” is used to make reference to the IEC 60601‐1:2005+A1:2012, any applicable

collateral standards and this document taken together.

Where there is no corresponding section, clause or subclause in this document, the section, clause or

subclause of the IEC 60601‐1 or applicable collateral standard, although possibly not relevant, applies

without modification; where it is intended that any part of the IEC 60601‐1 or applicable collateral

standard, although possibly relevant, is not to be applied, a statement to that effect is given in this

document.
© ISO 2017 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 80601-2-56:2017(E)
201.2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

IEC 60601‐1:2005+A1:2012, Clause 2 applies, except as follows:
Replacement:

IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance — Collateral Standard: Electromagnetic disturbances — 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
+Amendment 1:2013

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
+Amendment 1:2012
Addition:

ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14937:2009, 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 15223‐1:2016, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for

the processing of resterilizable medical devices

IEC 60601‐1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and

essential performance
+Amendment 1:2012

IEC 60601‐1‐11:2015, 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

IEC 60601‐1‐12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety

and essential performance — Collateral Standard: Requirements for medical electrical equipment and

medical electrical systems intended for use in the emergency medical services environment

IEC 62366‐1:2015, Medical devices — Part 1: Application of usability engineering to medical devices

© ISO 2017 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 80601-2-56:2017(E)
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601‐1:2005+A1:2012,

IEC 60601‐1‐8:2006+A1:2012, IEC 62366‐1:2015 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An alphabetized index of defined terms is found beginning in Annex DD.
IEC 60601‐1:2005+A1:2012, Clause 3 applies, except as follows:
Additions:
201.3.201
* ADJUSTED MODE

OPERATING MODE where the OUTPUT TEMPERATURE is calculated by adjusting the signal from the input

SENSOR

Note 1 to entry: For the purposes of this document, emissivity is considered a thermal or physiological property of

the MEASURING SITE, i.e. any CLINICAL THERMOMETER utilizing radiance that is dependent on emissivity is considered to

operate in an ADJUSTED MODE.
201.3.202
BLACKBODY

REFERENCE TEMPERATURE SOURCE of infrared radiation characterized by precisely known temperature and

having an effective emissivity close to one
201.3.203
BODY TEMPERATURE
all temperatures of the human body except SKIN TEMPERATURE
201.3.204
CLINICAL ACCURACY

closeness of agreement between the OUTPUT TEMPERATURE of a CLINICAL THERMOMETER and the true value

of the temperature of the REFERENCE BODY SITE that the CLINICAL THERMOMETER purports to represent

201.3.205
CLINICAL BIAS

mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL

THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured

from selected group of subjects

Note 1 to entry: LIMITS OF AGREEMENT can also be described as clinical uncertainty.

© ISO 2017 – All rights reserved
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ISO 80601-2-56:2017(E)
201.3.206
CLINICAL REPEATABILITY

pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT

TEMPERATURES taken from the same subject at the same MEASURING SITE with the same CLINICAL

THERMOMETER by the same OPERATOR within a relatively short time
201.3.207
* CLINICAL THERMOMETER

ME EQUIPMENT used for measuring at the MEASURING SITE and indicating the temperature at the REFERENCE

BODY SITE
Note 1 to entry: The MEASURING SITE can be the same as the REFERENCE
...

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