IEC 60601-1-9:2007

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-9:2007 The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle:
- product specification;
- design;
- manufacturing;
- sales, logistics, installation;
- use;
- end of life management. This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end of life management. The environmental impacts of me equipment through all life-cycle stages are determined from the medical electrical equipment's environmental aspects defined during the identification of need, product planning, and design stages. Consideration of environmental aspects as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. It can also provide new business opportunities, and improved product quality as well as reduction of adverse environmental impacts. The assessment of the environmental aspects and impacts of medical electrical equipment is a developing science and it is anticipated that this collateral standard will require periodic updating as the science develops. The requirements given in this collateral standard do not replace national or international laws and regulations. Environmental protection is one element of the overall risk management process as required by the general standard. The acceptability of medical electrical equipment's environmental impacts are balanced against other factors, such as the product's intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the medical electrical equipment. For example, a solution appropriate for life-saving or life-supporting medical electrical equipment might not be appropriate for a device intended to correct a minor ailment. A manufacturer of medical electrical equipment might have to justify, as a result of risk management, that a medical benefit outweighs the associated adverse environmental impacts.

Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

La CEI 60601-1-9:2007 L'objectif de la présente norme collatérale est d'améliorer l'impact environnemental pour toute la gamme d'appareils électromédicaux en tenant compte de toutes les étapes du cycle de vie du produit:
- spécification du produit;
- conception;
- fabrication;
- ventes, logistique, installation;
- utilisation;
- gestion de la fin de vie. Cela signifie protéger l'environnement et la santé des personnes contre les substances dangereuses, économiser les matières premières et l'énergie, minimiser la production de déchets, ainsi que minimiser les impacts environnementaux négatifs associés aux déchets. Les critères nécessaires pour atteindre ce but doivent être intégrés dans toutes les étapes du cycle de vie des appareils électromédicaux, dès l'étape de spécifications jusqu'à la gestion de fin de vie. Les impacts environnementaux des appareils électromédicaux à travers toutes les étapes du cycle de vie sont déterminés à partir des aspects environnementaux des appareils électromédicaux définis pendant les étapes d'identification des besoins, de planification et de conception du produit. La prise en compte des aspects environnementaux le plus tôt possible pendant ces étapes peut apporter de nombreux bénéfices qui pourraient inclure des coûts réduits, une stimulation de l'innovation et de la créativité et une meilleure connaissance du produit. Elle peut aussi apporter des nouvelles opportunités d'affaires, une meilleure qualité du produit ainsi qu'une réduction des impacts environnementaux négatifs. L'analyse des aspects et impacts environnementaux des appareils électromédicaux est une science en cours de développement et il est prévu que cette norme collatérale exige une mise à jour périodique au fur et à mesure que la science se développe. Les exigences données dans la présente norme collatérale ne remplacent pas les lois et réglementations nationales ou internationales. La protection environnementale est un des éléments du processus de gestion des risques global tel que demandé par la norme générale. L'acceptabilité des impacts environnementaux des appareils électromédicaux est prise en compte par rapport à d'autres facteurs, tels que la fonction prévue du produit, sa performance, sa sécurité, son prix, sa facilité de mise sur le marché, sa qualité, les exigences légales et réglementaires. L'équilibre peut être différent et dépend de la fonction prévue de l'appareil électromédical. Par exemple, une solution appropriée pour les appareils électromédicaux de sauvetage ou de maintien de la vie peut ne pas être appropriée pour un dispositif destiné à corriger une maladie mineure. Un fabricant d'appareils électromédicaux pourrait être amené à justifier, comme résultat de la gestion des risques, qu'un bénéfice médical à un poids plus important que les impacts environnementaux négatifs associés.

General Information

• Status: Published
• Publication Date: 21-Jul-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 13.020.01 - Environment and environmental protection in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 20 - TC 62/SC 62A/WG 20
• Current Stage: PPUB - Publication issued
• Start Date: 15-Sep-2007
• Completion Date: 10-Jul-2007

Relations

• Amended By: IEC 60601-1-9:2007/AMD2:2020 - Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 05-Sep-2023
• Amended By: IEC 60601-1-9:2007/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
CEI
60601-1-9
NORME
First edition
INTERNATIONALE
Première édition
2007-07
Medical electrical equipment –
Part 1-9:
General requirements for basic
safety and essential performance –
Collateral Standard: Requirements for
environmentally conscious design

Appareils électromédicaux –
Partie 1-9:
Exigences générales pour la sécurité
de base et les performances essentielles –
Norme collatérale: Exigences pour une
conception éco-responsable
Reference number
Numéro de référence
IEC/CEI 60601-1-9:2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de
référence, texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou
remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
INTERNATIONAL IEC
STANDARD
CEI
60601-1-9
NORME
First edition
INTERNATIONALE
Première édition
2007-07
Medical electrical equipment –
Part 1-9:
General requirements for basic
safety and essential performance –
Collateral Standard: Requirements for
environmentally conscious design

Appareils électromédicaux –
Partie 1-9:
Exigences générales pour la sécurité
de base et les performances essentielles –
Norme collatérale: Exigences pour une
conception éco-responsable
PRICE CODE
U
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 2 – 60601-1-9 © IEC:2007
CONTENTS
FOREWORD.3
INTRODUCTION.6

1 Scope, object and related standards.7
1.1 * Scope .7
1.2 Object .7
1.3 Related standards .7
2 Normative references .7
3 Terms and definitions .8
4 Protection of the ENVIRONMENT.10
4.1 * Identification of ENVIRONMENTAL ASPECTS.10
4.2 * Determination of significant ENVIRONMENTAL ASPECTS.10
4.3 * Information from the SUPPLY CHAIN .10
4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS .11
4.5 Environmental information.11

Annex A (informative) General guidance and rationale.13
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT .28

Bibliography.29
Index of defined terms used in this collateral standard.30

Table A.1 – Example product LIFE-CYCLE stages .14
Table A.2 – Examples of ENVIRONMENTAL IMPACTS and their cause .20
Table A.3 – ENVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS .23
Table B.1 – ACCOMPANYING DOCUMENTS, General .28
Table B.2 – Other information .28

60601-1-9 © IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-9: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for environmentally conscious design

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-1-9 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for safety and essential performance hereafter
referred to as the general standard.

– 4 – 60601-1-9 © IEC:2007
The text of this standard is based on the following documents:
FDIS Report on voting
62A/571/FDIS 62A/575/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. alarm systems).
In this collateral standard, 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 COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the four numbered divisions within the table of contents, inclusive
of all subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 4.1, 4.5 and 4.5.1 are all
subclauses of Clause 4).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

60601-1-9 © IEC:2007 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
---------------------- Pag
...

IEC 60601-1-9 ®
Edition 1.1 2013-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-9: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour une conception éco-
responsable
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les
microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: [e-mail].

A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.

Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
Just Published CEI - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications de la CEI.
Just Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur
Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: [e-mail].
IEC 60601-1-9 ®
Edition 1.1 2013-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1-9: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences pour une conception éco-

responsable
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040; 13.020 ISBN 978-2-8322-0876-2

– 2 – 60601-1-9  IEC:2007+A1:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION TO THE AMENDMENT . 7

1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 Object . 8
1.3 Related standards . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Protection of the ENVIRONMENT . 11
4.1 * Identification of ENVIRONMENTAL ASPECTS . 11
4.2 * Determination of significant ENVIRONMENTAL ASPECTS . 11
4.3 * Information from the SUPPLY CHAIN . 11
4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS . 12
4.5 Environmental information . 12

Annex A (informative) General guidance and rationale . 14
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT . 29

Bibliography . 30
Index of defined terms used in this collateral standard . 31

Table A.1 – Example product LIFE-CYCLE stages . 15
Table A.2 – Examples of ENVIRONMENTAL IMPACTS and their cause . 21
Table A.3 – ENVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS . 24
Table B.1 – ACCOMPANYING DOCUMENTS, General . 29
Table B.2 – Other information . 29

60601-1-9  IEC:2007+A1:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-9: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for environmentally conscious design

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

This consolidated version of IEC 60601-1-9 consists of the first edition (2007)
[documents 62A/571/FDIS and 62A/575/RVD] and its amendment 1 (2013) [documents
62A/874/FDIS and 62A/881/RVD]. It bears the edition number 1.1.

The technical content is therefore identical to the base edition and its amendment and
has been prepared for user convenience. A vertical line in the margin shows where the
base publication has been modified by amendment 1. Additions and deletions are
displayed in red, with deletions being struck through.

– 4 – 60601-1-9  IEC:2007+A1:2013
International standard IEC 60601-1-9 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
The first edition of this publication constitutes a collateral standard to IEC 60601-1: Medical
electrical equipment – Part 1: General requirements for safety and essential performance
hereafter referred to as the general standard.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. alarm systems).
In this collateral standard, 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 COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the four numbered divisions within the table of contents, inclusive
of all subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 4.1, 4.5 and 4.5.1 are all
subclauses of Clause 4).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditio
...

IEC 60601-1-9 ®
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-9: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour une conception éco-
responsable
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need further assistance, please contact the Customer Service

Centre: [e-mail].
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Recherche de publications IEC - Electropedia - www.electropedia.org
webstore.iec.ch/advsearchform Le premier dictionnaire d'électrotechnologie en ligne au
La recherche avancée permet de trouver des publications IEC monde, avec plus de 22 000 articles terminologiques en
en utilisant différents critères (numéro de référence, texte, anglais et en français, ainsi que les termes équivalents dans
comité d’études,…). Elle donne aussi des informations sur les 16 langues additionnelles. Egalement appelé Vocabulaire
projets et les publications remplacées ou retirées. Electrotechnique International (IEV) en ligne.

IEC Just Published - webstore.iec.ch/justpublished Glossaire IEC - std.iec.ch/glossary
Restez informé sur les nouvelles publications IEC. Just 67 000 entrées terminologiques électrotechniques, en anglais
Published détaille les nouvelles publications parues. et en français, extraites des articles Termes et définitions des
Disponible en ligne et une fois par mois par email. publications IEC parues entre 2002 et 2015. Plus certaines
entrées antérieures extraites des publications des CE 37, 77,
Service Clients - webstore.iec.ch/csc 86 et CISPR de l'IEC.

Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
[e-mail].
IEC 60601-1-9 ®
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1-9: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences pour une conception éco-

responsable
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 13.020.01 ISBN 978-2-8322-8707-1

IEC 60601-1-9 ®
Edition 1.2 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-9: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour une conception éco-
responsable
– 2 – IEC 60601-1-9:2007+AMD1:2013
+AMD2:2020 CSV  IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 Object . 8
1.3 Related standards . 8
2 Normative references . 9
3 Terms and definitions . 9
4 Protection of the ENVIRONMENT . 11
4.1 * Identification of ENVIRONMENTAL ASPECTS . 11
4.2 * Determination of significant ENVIRONMENTAL ASPECTS . 11
4.3 * Information from the SUPPLY CHAIN . 11
4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS . 12
4.5 Environmental information . 12
Annex A (informative) General guidance and rationale . 14
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT . 29
Bibliography . 30
Index of defined terms used in this collateral standard . 31

Table A.1 – Example product LIFE-CYCLE stages . 15
Table A.2 – Examples of ENVIRONMENTAL IMPACTS and their cause . 21
Table A.3 – ENVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS . 24
Table B.1 – ACCOMPANYING DOCUMENTS, General . 29
Table B.2 – Other information . 29

+AMD2:2020 CSV  IEC 2020
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-9: General requirements for basic safety
and essential performance –
Collateral Standard:
Requirements for environmentally conscious design

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-1-9 edition 1.2 contains the first edition (2007-07) [documents 62A/571/FDIS
and 62A/575/RVD], its amendment 1 (2013-06) [documents 62A/874/FDIS and
62A/881/RVD] and its amendment 2 (2020-07) [documents 62A/1393/FDIS and
62A/1408/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 4 – IEC 60601-1-9:2007+AMD1:2013
+AMD2:2020 CSV  IEC 2020
International standard IEC 60601-1-9 has been prepared by IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice, of IEC technical committee 62:
Electrical equipment in medical practice.
The first edition of this publication constitutes a collateral standard to IEC 60601-1: Medical
electrical equipment – Part 1: General requirements for safety and essential performance
hereafter referred to as the gener
...