Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature.
Not included within the scope of this document are:
- invasive tissue or vascular oximeters;
- oximeters that require a blood sample from the patient;
- equipment measuring dissolved oxygen;
- ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4];
- ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61[3];
- ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head.
This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.
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 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability.
This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

Appareils électromédicaux - Partie 2-85: Exigences particulières pour la sécurité de base et les performances essentielles des oxymètres pour tissu cérébral

Le présent document s'applique à la sécurité de base et aux performances essentielles des oxymètres pour tissu cérébral, qui utilisent la lumière à plusieurs longueurs d'onde afin d'obtenir une mesure quantitative de la saturation en oxygène de l'hémoglobine dans le volume de tissu échantillonné sous le capteur fixé à la tête. L'oxymètre pour tissu cérébral peut s'appuyer sur des technologies de lumière continue, de domaine fréquentiel ou de domaine temporel. Le présent document s'applique aux appareils EM utilisés en environnement hospitalier ou en dehors de l'environnement hospitalier, par exemple dans des ambulances ou lors d'un transport aérien. D'autres normes peuvent s'appliquer aux appareils EM pour ces environnements d'utilisation.
NOTE 1 Les oxymètres pour tissu cérébral sont parfois appelés « appareils de spectroscopie dans le proche infrarouge » ou « appareils NIRS » (near infrared spectroscopy) dans la littérature médicale.
Les éléments suivants ne relèvent pas du domaine d'application du présent document :
- les oxymètres tissulaires ou vasculaires invasifs ;
- les oxymètres nécessitant un échantillon sanguin du patient ;
- les appareils de mesure de l'oxygène dissous ;
- les appareils EM, ou parties de ceux-ci, qui mesurent le changement de l'hémoglobine en fonction de la longueur du trajet. Les exigences relatives aux appareils de spectroscopie dans le proche infrarouge figurent dans l'ISO 80601-2-71 [4] ;
- les appareils EM, ou parties de ceux-ci, qui mesurent la saturation artérielle en fonction des changements pulsatiles dans les propriétés optiques des tissus (SpO2). Les exigences relatives aux oxymètres de pouls figurent dans l'ISO 80601-2-61 [3] ;
- les appareils EM, ou parties de ceux-ci, qui revendiquent la surveillance des tissus dans des parties du corps autres que la tête.
Le présent document s'applique également aux oxymètres pour tissu cérébral, y compris les moniteurs d'oxymètres pour tissu cérébral, les capteurs d'oxymètres pour tissu cérébral et les câbles de raccordement du capteur, qui ont fait l'objet d'une remise à neuf.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11, 201.7.2.13 et 201.8.4.1 de la norme générale.
NOTE 2 Voir également 4.2 de la norme générale.
Le présent document peut également être appliqué aux appareils EM et leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité.
Le présent document ne s'applique pas aux appareils à distance ou esclaves (secondaires) qui affichent les valeurs de StO2 et qui sont situés en dehors de l'environnement du patient.
NOTE 3 Il est attendu que les appareils EM qui offrent le choix entre des fonctions de diagnostic et de surveillance respectent les exigences du document approprié lorsqu'ils sont configurés pour cette fonction.

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Published
Publication Date
25-Mar-2021
Current Stage
PPUB - Publication issued
Completion Date
29-Mar-2021
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ISO 80601-2-85:2021 - Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
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INTERNATIONAL ISO
STANDARD 80601-2-85
First edition
2021-03
Medical electrical equipment —
Part 2-85:
Particular requirements for the basic
safety and essential performance of
cerebral tissue oximeter equipment
Appareils électromédicaux —
Partie 2-85: Exigences particulières pour la sécurité de base et les
performances essentielles des oxymètres pour tissu cérébral
Reference number
ISO 80601-2-85:2021(E)
ISO 2021
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ISO 80601-2-85:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO 80601-2-85:2021(E)
Contents Page

Foreword ......................................................................................................................................................................... vi

Introduction .................................................................................................................................................................. vii

201.1 Scope, object and related standards .......................................................................................................... 1

201.1.1 * Scope ............................................................................................................................................................... 1

201.1.2 Object ................................................................................................................................................................. 2

201.1.3 Collateral standards ..................................................................................................................................... 2

201.1.4 Particular standards .................................................................................................................................... 3

201.2 Normative references ..................................................................................................................................... 4

201.3 Terms and definitions ..................................................................................................................................... 5

201.4 General requirements .................................................................................................................................. 10

201.4.3.101 * Additional requirements for essential performance ......................................................... 11

201.4.102 Additional requirements for acceptance criteria .................................................................... 11

201.4.103 Additional requirements for cerebral tissue oximeter equipment, parts and

accessories ....................................................................................................................................................... 11

201.5 General requirements for testing of ME equipment .......................................................................... 12

201.6 Classification of ME equipment and ME systems ................................................................................. 12

201.7 ME equipment identification, marking and documents ................................................................... 12

201.7.1.101 Information to be supplied by the manufacturer .................................................................... 12

201.7.2.3 Consult accompanying documents .................................................................................................... 12

201.7.2.9.101 IP classification ............................................................................................................................... 12

201.7.2.101 Additional requirements for marking on the outside of ME equipment parts ............ 13

201.7.4.3 Units of measurement ........................................................................................................................... 13

201.7.9.2 Instructions for use ................................................................................................................................ 13

201.7.9.2.1.101 Additional general requirements......................................................................................... 13

201.7.9.2.2.101 Additional requirements for warnings and safety notices ......................................... 15

201.7.9.2.9.101 Additional requirements for operating instructions .................................................... 15

201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used

material ............................................................................................................................................................ 15

1.7.9.3.1.101 * Additional general requirements ...................................................................................... 16

201.8 Protection against electrical hazards from ME equipment ............................................................. 16

201.8.3.101 Additional requirements for classification of applied parts .............................................. 16

201.8.5.5.1.101 Defibrillation protection ........................................................................................................ 16

201.8.7.4.7.101 Additional requirements for measurement of the patient leakage current ........ 16

201.9 Protection against mechanical hazards of ME equipment and ME systems ............................... 17

201.10 Protection against unwanted and excessive radiation hazards ................................................ 17

201.10.4 Lasers ........................................................................................................................................................... 17

201.11 Protection against excessive temperatures and other hazards ................................................. 17

201.11.1.2.2 Applied parts not intended to supply heat to a patient ...................................................... 17

201.11.6.5.101 * Additional requirements for ingress of water or particulate matter into

the ME equipment or ME system............................................................................................................... 18

201.11.6.7 Sterilization of ME equipment or ME system ............................................................................... 18

201.11.8.101 Additional requirements for interruption of the power supply/supply mains

to ME equipment ............................................................................................................................................ 18

© ISO 2021 – All rights reserved iii
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ISO 80601-2-85:2021(E)

201.11.8.101.1 Technical alarm condition for power supply failure ...................................................... 18

201.11.8.101.2 Settings and data storage following short interruptions or automatic

switchover ...................................................................................................................................................... 19

201.11.8.101.3 Operation following long interruptions ............................................................................. 19

201.12 Accuracy of controls and instruments and protection against hazardous outputs............ 19

201.12.1.101 * StO accuracy of cerebral tissue oximeter equipment ..................................................... 19

201.12.1.101.1 * Specification .............................................................................................................................. 19

201.12.1.101.2 * Data collection for determination of StO accuracy .................................................... 21

201.12.1.101.3 * Data analysis for determination of StO accuracy ........................................................ 22

201.12.1.101.4 Characteristics of the study used for determination of StO accuracy .................... 23

201.12.4 Protection against hazardous output .............................................................................................. 23

201.12.4.101 * Data update period ..................................................................................................................... 23

201.12.4.102 * Signal inadequacy ...................................................................................................................... 23

201.13 Hazardous situations and fault conditions for ME equipment .................................................... 24

201.13.101 Detection of probe faults and probe cable extender faults .................................................. 24

201.14 Programmable electrical medical systems (PEMS) .......................................................................... 24

201.15 Construction of ME equipment ............................................................................................................... 24

201.15.3.5.101 * Additional requirements for rough handling ................................................................ 25

201.15.3.5.101.1 * Shock and vibration (robustness) .................................................................................. 25

201.15.3.5.101.2 * Shock and vibration for a transit-operable cerebral tissue oximeter

during operation .......................................................................................................................................... 26

201.15.101 Mode of operation.............................................................................................................................. 27

201.16 ME systems..................................................................................................................................................... 27

201.17 Electromagnetic compatibility of ME equipment and ME systems............................................. 27

201.101 * Cerebral tissue oximeter probes and probe cable extenders ................................................... 27

201.101.1 General ..................................................................................................................................................... 27

201.101.2 Labelling .................................................................................................................................................. 28

201.102 Functional connection ............................................................................................................................. 28

201.102.1 General ..................................................................................................................................................... 28

201.102.2 * Connection to an electronic health record or integrated clinical environment .......... 28

201.102.3 Connection to a distributed alarm system ................................................................................... 28

202 Electromagnetic disturbances — Requirements and tests ................................................................ 29

202.4.3.1 Configurations ......................................................................................................................................... 29

202.5.2.2.1 Requirements applicable to all ME equipment and ME systems ........................................ 29

202.8.1.101 Additional general requirements ............................................................................................... 29

202.8.2 Patient physiological simulation .......................................................................................................... 29

206 Usability ........................................................................................................................................................... 30

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

equipment and medical electrical systems......................................................................................... 30

208.6.1.2.101 * Additional requirements for alarm condition priority ................................................. 30

208.6.5.4.101 * Additional requirements for default alarm preset ......................................................... 31

208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and

access ................................................................................................................................................................ 31

211 Requirements for medical electrical equipment and medical electrical systems used

in the home healthcare environment ................................................................................................... 31

212 Requirements for medical electrical equipment and medical electrical systems used

in the emergency medical services environment ............................................................................. 31

iv © ISO 2021 – All rights reserved
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ISO 80601-2-85:2021(E)

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

ME systems ....................................................................................................................................................... 32

Annex D (informative) Symbols on marking...................................................................................................... 36

Annex AA (informative) Particular guidance and rationale ........................................................................ 37

Annex BB (informative) Skin temperature at the cerebral tissue oximeter probe ............................... 48

Annex CC (informative) Determination of accuracy ....................................................................................... 50

Annex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification

of the accuracy of cerebral tissue oximeter equipment .................................................................... 56

Annex EE (informative) Guideline for evaluating and documenting StO accuracy in human

subjects ............................................................................................................................................................. 66

Annex FF (informative) Functional testers for cerebral tissue oximeter equipment ............................ 72

Annex GG (informative) Concepts of ME equipment response time .......................................................... 75

Annex HH (normative) Data interface requirements ..................................................................................... 80

Annex II (informative) Comparison of methods of performance evaluation ......................................... 84

Annex JJ (informative) Reference to the IMDRF essential principles and labelling guidances ........ 89

Annex KK (informative) Reference to the essential principles .................................................................... 92

Annex LL (informative) Reference to the general safety and performance requirements ............... 95

Annex MM (informative) Terminology — alphabetized index of defined terms .................................. 98

Bibliography .............................................................................................................................................................. 102

© ISO 2021 – All rights reserved v
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ISO 80601-2-85:2021(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 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 jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and

Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee 62D,

Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)

Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the

Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.

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.
vi © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 80601-2-85:2021(E)
Introduction

The estimation of blood oxygen saturation in the brain tissue by cerebral tissue oximetry equipment is

increasingly used in many areas of medicine. This document covers basic safety and essential

performance requirements achievable within the limits of existing technology.

Annex AA contains a rationale for some of the requirements. It is included to provide additional insight

into the reasoning of the committees that led to a requirement and into the hazards that the

requirement addresses.

Annex BB is a literature review and provides recommendations relevant to determining the maximum

safe temperature of the interface between a cerebral tissue oximeter probe and a patient's tissue.

Annex CC discusses both the formulae used to evaluate the StO accuracy of cerebral tissue oximeter

equipment measurements, and the names that are assigned to those formulae.

Annex DD presents guidance on using in-vitro methods (phantoms) for verification of StO accuracy of

cerebral tissue oximeter equipment.

Annex EE presents a guideline for an in-vivo (human subjects) controlled desaturation study for the

verification of StO accuracy of cerebral tissue oximeter equipment.

Annex FF is a description of functional testers for use with cerebral tissue oximeter equipment.

Annex GG describes concepts of cerebral tissue oximeter equipment response time.
Annex HH describes data interface requirements.

Annex II is a comparison between human desaturations (in-vivo) and tissue haemoglobin phantom

desaturations (in-vitro) for assessing StO accuracy.
In this document, the following print types are used:
— requirements and definitions: roman type;

— Instructions, test specifications and terms defined in Clause 3 of the general standard, in this document

or as noted: 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.
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 201.7 includes subclauses 201.7.1, 201.7.2) and

— “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 7.2 and 201.7.2.1 are all

subclauses of Clause 201.7).

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.
© ISO 2021 – All rights reserved vii
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ISO 80601-2-85:2021(E)

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.
For the purposes of this document, the auxiliary verb:

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

this document;

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

mandatory for conformance with this document; and

— “may” is used to describe permission (e.g. a permissible way to achieve conformance with a

requirement or test);
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.

Annex C contains a guide to the marking and labelling requirements in this document.

Annex D contains a summary of the symbols referenced in this document.

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 AA.
viii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
INTERNATIONAL STANDARD ISO 80601-2-85:2021(E)
Medical electrical equipment —
Part 2-85:
Particular requirements for the basic safety and essential
performance of cerebral tissue oximeter equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 * Scope
Replacement:

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment,

that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of

haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral

tissue oximeter equipment can be based on continuous light, frequency domain or time domain

technologies. This document applies to ME equipment used in a hospital environment as well as when

used outside the hospital environment, such as in ambulances and air transport. Additional standards

may apply to ME equipment for those environments of use.

NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical

literature.
Not included within the scope of this document are:
 invasive tissue or vascular oximeters;
 oximeters that require a blood sample from the patient;
 equipment measuring dissolved oxygen;

 ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The

[4]

requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71 ;

 ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in

tissue optical properties (SpO ). The requirements for pulse oximeter equipment are found in

[3]
ISO 80601-2-61 ;

 ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the

head.

This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter

monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured.

© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
ISO 80601-2-85:2021(E)

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 201.11 and

in 201.7.2.13 and 201.8.4.1 of the general standard.
NOTE 2 See also 4.2 of the general standard.

This document can also be applied to ME equipment and their accessories used for compensation or

alleviation of disease, injury or disability.

This document is not applicable to remote or slave (secondary) equipment that displays StO values

that are located outside of the patient environment.

NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet

the requirements of the appropriate document when configured for that function.
201.1.2 Object
Replacement:

The object of this document is to establish particular basic safety and essential performance

requirements for cerebral tissue oximeter equipment [as defined in 201.3.202] and its accessories.

NOTE 1 Accessories are included because the combination of the cerebral tissue oximeter monitor and the

accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential

performance of cerebral tissue oximeter equipment.

NOTE 2 This document has been prepared to address the relevant International Medical Device Regulators Forum

(IMDRF) essential principles and labelling guidances as indicated in Annex JJ.

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of

ISO 16142-1:2016 as indicated in Annex KK.

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of

[20]
European regulation (EU) 2017/745 as indicated in Annex LL.
201.1.3 Collateral standards
Addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of the general

standard and Clause 201.2 of this document.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-11:2015+AMD1:2020 and

IEC 60601-1-12:2014+AMD1:2020 apply as modified 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.
2 © ISO 2021 – All rights reserved
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ISO 80601-2-85:2021(E)
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards define basic safety and essential performance

requirements, and may modify, replace or delete requirements contained in the general standard,

including the collateral standards, as appropriate for the particular ME equipment under consideration.

A requirement of a particular standard takes priority over the general standard or the collateral

standards.

For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this document as the general

standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to those 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 “2xx” where xx is the final digits of

the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4

of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause 4 of

the IEC 60601-1-8 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 general standard or applicable collateral

standard is replaced completely by the text of this document.

"Addition" means that the text of this document is additional to the requirements of the general

standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable collateral

standard is amended as indicated by the text of this document.

Clauses, subclauses or figures that are additional to those of the general standard are numbered starting

from 201.101. However, due to the fact that definitions in
...

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