EN 60601-1-9:2008

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

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.

Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen zur Reduzierung von Umweltauswirkungen

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

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.

Medicinska električna oprema - 1-9. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za okoljsko osveščeno snovanje (IEC 60601-1-9:2007)

Ta mednarodni standard se uporablja za omejevanje negativnih OKOLJSKIH VPLIVOV MEDICINSKE ELEKTRIČNE OPREME, v nadaljnjem besedilu: ME OPREMA. MEDICINSKI ELEKTRIČNI SISTEMI so izključeni s področja uporabe tega spremljevalnega standarda.

General Information

• Status: Published
• Publication Date: 28-Apr-2008
• Withdrawal Date: 30-Apr-2011
• ICS: 11.040 - Medical equipment
• ICS: 13.020 - Environmental protection
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Parallel Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 29-Apr-2008
• Completion Date: 29-Apr-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-1-9:2008 - Medical electrical equipment -- Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Relations

• Amended By: EN 60601-1-9:2008/A1:2013 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 29-Jan-2023
• Amended By: EN 60601-1-9:2008/A2:2020 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 24-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2008
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DRNROMVNRRVYHãþHQR
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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)
Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
zur Reduzierung von Umweltauswirkungen (IEC 60601-1-9:2007)
Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Exigences pour une conception éco-
responsable (CEI 60601-1-9:2007)
Ta slovenski standard je istoveten z: EN 60601-1-9:2008
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
13.020.01 Okolje in varstvo okolja na Environment and
splošno environmental protection in
general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-9
NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM
ICS 11.040; 13.020
English version
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)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-9: Exigences générales Teil 1-9: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Exigences Ergänzungsnorm: Anforderungen
pour une conception éco-responsable zur Reduzierung
(CEI 60601-1-9:2007) von Umweltauswirkungen
(IEC 60601-1-9:2007)
This European Standard was approved by CENELEC on 2008-04-16. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-9:2008 E
Foreword
The text of document 62A/571/FDIS, future edition 1 of IEC 60601-1-9, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 60601-1-9 on 2008-04-16.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2009-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
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.

- 3 - EN 60601-1-9:2008
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 (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-9:2007 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
ISO 14001 NOTE Harmonized as EN ISO 14001:2004 (not modified).
ISO 14021 NOTE Harmonized as EN ISO 14021:2001 (not modified).
ISO 14040 NOTE Harmonized as EN ISO 14040:2006 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year

IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
- 5 - EN 60601-1-9:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers the
following essential requirements as given in Annex I of the EC Directive 93/42/EEC:
1, 2, 4, 7.1, 7.5, 12.7.2, 12.7.3, 13.1, 13.3 and 13.6.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling
within the scope of this standard.
___________
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-
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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 Publica
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