SIST EN 60601-1-9:2008

SLOVENSKI STANDARD
01-julij-2008
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DRNROMVNRRVYHãþHQR
VQRYDQMH,(&
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-
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.
– 6 – 60601-1-9 © IEC:2007
INTRODUCTION
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 (see Table A.1). 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.

60601-1-9 © IEC:2007 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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

1 Scope, object and related standards
1.1 * Scope
This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of
MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.
1.2 Object
The object of this collateral standard is to specify general requirements, in addition to those of
the general standard, for the reduction of the adverse ENVIRONMENTAL IMPACT of
ME EQUIPMENT, and to serve as the basis for particular standards.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
– "the general standard" designates IEC 60601-1 alone;
– "this collateral standard" designates IEC 60601-1-9 alone;
– "this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
1.3.3 Environmental standards
This standard takes into account the ISO 14000 series of environmental standards with
1)
particular emphasis on ISO 14062 [8] .
2 Normative references
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.
—————————
1)
Figures in square brackets refer to the Bibliography.

– 8 – 60601-1-9 © IEC:2007
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
the following definitions apply.
NOTE An index of defined terms is found beginning on page 30.
3.1
DESIGN AND DEVELOPMENT
set of PROCESSES that transforms requirements into specified characteristics or into the
specification of a product, PROCESS or system
NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define
different stages of the overall PROCESS of turning an idea into a product.
NOTE 2 Product development is the PROCESS of taking a product idea from planning to market launch and post-
market review of the product, in which business strategies, marketing considerations, research methods and design
aspects are used to take a product to a point of practical use. It includes improvements or modifications to existing
products or PROCESSES
NOTE 3 The integration of ENVIRONMENTAL ASPECTS into product DESIGN AND DEVELOPMENT can also be termed
design for the ENVIRONMENT (DFE), eco-design, the environmental part of product stewardship, etc.
[ISO/TR 14062:2002, definition 3.3]
3.2
END OF LIFE
EOL
state of a ME EQUIPMENT when it is finally removed from its INTENDED USE
NOTE Adapted from IEC Guide 109:2003, Definition 3.1.
3.3
ENVIRONMENT
surroundings in which an ORGANIZATION operates, including air, water, land, natural resources,
flora, fauna, humans and their interrelation
NOTE Surroundings in this context extend from within an ORGANIZATION to the global system.
[ISO 14001:2004, definition 3.5]
3.4
* ENVIRONMENTAL ASPECT
element of an ORGANIZATION’S activities, products or services that can interact with the
ENVIRONMENT
NOTE A significant ENVIRONMENTAL ASPECT has or can have a significant ENVIRONMENTAL IMPACT.
[ISO 14001:2004, definition 3.6]
3.5
* ENVIRONMENTAL IMPACT
any change to the ENVIRONMENT, whether adverse or beneficial, wholly or partially resulting
from an ORGANIZATION'S ENVIRONMENTAL ASPECTS
[ISO 14001:2004, definition 3.7]

60601-1-9 © IEC:2007 – 9 –
3.6
HAZARDOUS SUBSTANCE
substance which can affect human health or the ENVIRONMENT with an immediate or retarded
effect
[IEC Guide 109: 2003, definition 3.6, modified]
3.7
LIFE CYCLE
consecutive and interlinked stages of a product system, from raw material acquisition or
generation from natural resources to final disposal
[ISO 14040:2006, definition 3.1]
3.8
LIFE-CYCLE ASSESSMENT
LCA
compilation and evaluation of the inputs, outputs and the potential ENVIRONMENTAL IMPACTS of
a product system throughout its LIFE CYCLE
[ISO 14040:2006, definition 3.2]
3.9
ORGANIZATION
company, corporation, firm, enterprise, authority or institution, or part or combination thereof,
whether incorporated or not, public or private, that has its own functions and administration
NOTE For ORGANIZATIONS with more than one operating unit, a single operating unit may be defined as an
ORGANIZATION.
[ISO 14001:2004, definition 3.16]
3.10
PACKAGING
material that is used to protect or contain a product during transportation, storage and
marketing
NOTE 1 For the purposes of this standard, the term PACKAGING also includes any item that is physically attached
to, or included with, a product or its container for the purpose of marketing the product.
NOTE 2 Adapted from ISO 14021:1999, definition 3.1.10.
3.11
RECYCLING
reprocessing in a production PROCESS of the WASTE materials for the original purpose or for
other purposes but excluding energy recovery
[IEC Guide 109:2003, definition 3.16]
3.12
REUSE
utilization of ME EQUIPMENT or a part of ME EQUIPMENT, after it has been disposed of by the
RESPONSIBLE ORGANIZATION as WASTE, for a similar purpose to that for which it was originally
intended by the MANUFACTURER
3.13
SUPPLY CHAIN
those involved, through upstream and downstream linkages, in PROCESSES and activities
delivering value in the form of products to the MANUFACTURER
NOTE 1 In practice, the expression “interlinked chain” applies from suppliers to those involved in END OF LIFE
processing.
NOTE 2 In practice, the expressions “product chain”, “value chain” are often used.
NOTE 3 Adapted from ISO/TR 14062:2002, definition 3.9.

– 10 – 60601-1-9 © IEC:2007
3.14
WASTE
substance or object which the holder disposes of, or is required to dispose of, pursuant to the
provisions of national law in force
[IEC Guide 109:2003, definition 3.18]
4 Protection of the ENVIRONMENT
4.1 * Identification of ENVIRONMENTAL ASPECTS
HE MANUFACTURER shall establish, implement and maintain a PROCESS to identify and
T
document the relevant ENVIRONMENTAL ASPECTS of ME EQUIPMENT across all LIFE-CYCLE stages.
Examples of ENVIRONMENTAL ASPECTS are:
– use of HAZARDOUS SUBSTANCES;
– emissions to air;
– releases to surface water and ground water;
– WASTE, especially HAZARDOUS SUBSTANCES;
– use of natural resources, energy and raw materials;
– noise, vibration, odour, dust, electromagnetic fields etc.;
– transport (both for goods and services and employees);
– RISKS from environmental accidents and ENVIRONMENTAL IMPACTS arising, or likely to arise,
as consequences of incidents, accidents and potential emergency situations; and
– use and contamination of the biosphere.
Compliance is checked by inspection of the relevant design documents and PROCESS
description.
4.2 * Determination of significant ENVIRONMENTAL ASPECTS
MANUFACTURER shall establish, implement and maintain a PROCESS to qualitatively or
The
quantitatively determine and document the ENVIRONMENTAL ASPECTS that can have significant
ENVIRONMENTAL IMPACTS (i.e. significant ENVIRONMENTAL ASPECTS) during all LIFE-CYCLE stages
of the ME EQUIPMENT.
Compliance is checked by inspection of the relevant design documents and PROCESS
description.
4.3 * Information from the SUPPLY CHAIN
The MANUFACTURER shall establish, implement and maintain PROCESSES to:
– identify those suppliers (including services) that are likely to contribute significant
ENVIRONMENTAL ASPECTS to the ME EQUIPMENT; and
– obtain from those SUPPLIERS the information necessary to assist the MANUFACTURER in
identifying and assessing the ENVIRONMENTAL ASPECTS of the ME EQUIPMENT as required in
4.1 and 4.2.
If, despite the MANUFACTURER’S efforts, ORGANIZATIONS within the SUPPLY CHAIN fail to provide
the information requested by the MANUFACTURER, the MANUFACTURER shall provide an
estimation of the missing information and document the rationale.
NOTE To fully assess the ENVIRONMENTAL ASPECTS across the entire life of the ME EQUIPMENT it is necessary for
the MANUFACTURER to gather information and involve the environmentally significant SUPPLIERS during the concept
and design stage.
60601-1-9 © IEC:2007 – 11 –
Compliance is checked by inspection of the relevant design documents and PROCESS
description.
4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS
The MANUFACTURER shall establish and document targets for the significant ENVIRONMENTAL
ASPECTS of the ME EQUIPMENT to minimize as far as reasonable the adverse ENVIRONMENTAL
IMPACTS across all LIFE-CYCLE stages. The documented targets shall be based on functional as
well as environmental requirements, and, when available, previous product designs.
During the ME EQUIPMENT concept and specification setting stage, the MANUFACTURER shall
consider, as far as reasonable, novel emerging or alternative technologies and/or solutions for
the ME EQUIPMENT that reduce significant adverse ENVIRONMENTAL IMPACTS.
The MANUFACTURER shall assess and document the actual significant ENVIRONMENTAL ASPECTS
across all LIFE-CYCLE stages of a representative prototype of the final design of the ME
EQUIPMENT. Any deviations from the targets shall be assessed and documented for
consideration in future designs.
Compliance is checked by inspection of the relevant design documents.
4.5 Environmental information
4.5.1 * PACKAGING of ME EQUIPMENT
The MANUFACTURER shall make available information on the type and mass of PACKAGING
material(s).
NOTE ‘Type’ of PACKAGING refers, as a minimum, to the generic description (e.g. cardboard, plastic, wood, glass
etc).
Compliance is checked by verifying the availability of the information.
4.5.2 * Instructions for minimizing ENVIRONMENTAL IMPACT during NORMAL USE
The MANUFACTURER shall provide instructions for minimizing the ENVIRONMENTAL IMPACT of the
ME EQUIPMENT during NORMAL USE in the ACCOMPANYING DOCUMENTS.
The instructions shall cover the following items where applicable:
– instructions on how to install the ME EQUIPMENT in order to minimize the ENVIRONMENTAL
IMPACT during its EXPECTED SERVICE LIFE;
– instructions on how to use and maintain the ME EQUIPMENT in order to minimize the
ENVIRONMENTAL IMPACT during its EXPECTED SERVICE LIFE;
– consumption during NORMAL USE (e.g. energy, consumable materials/parts, disposables,
water, gasses, chemicals/reagents etc.);
– emissions during NORMAL USE (e.g. WASTE water, WASTE consumable materials, acoustic
energy, heat, gasses, vapours, particulates, HAZARDOUS SUBSTANCES and other WASTE);
and
– information on the location within the ME EQUIPMENT of HAZARDOUS SUBSTANCES,
radioactive sources and induced radioactive materials.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

– 12 – 60601-1-9 © IEC:2007
4.5.3 * Information for END OF LIFE management
The MANUFACTURER shall provide the RESPONSIBLE ORGANIZATION with information for the
proper disposal of the ME EQUIPMENT at END OF LIFE.
The MANUFACTURER shall make available information to WASTE treatment facilities necessary
for the environmentally responsible management of END OF LIFE ME EQUIPMENT. The
information shall contain:
– the location of components and parts within the ME EQUIPMENT that contain stored energy
or pose other HAZARDS that can result in an unacceptable RISK to disassemblers or others
and methods for controlling such RISKS;
– the identity and location of HAZARDOUS SUBSTANCES requiring special handling and
treatment; and
– disassembly instructions sufficient for the safe removal of these HAZARDOUS SUBSTANCES
including radioactive sources and induced radioactive materials within the ME EQUIPMENT.
Compliance is checked by verifying the availability of the information.

60601-1-9 © IEC:2007 – 13 –
Annex A
(informative)
General guidance and rationale

A.1 General guidance
In the future, MANUFACTURERS and RESPONSIBLE ORGANIZATIONS will be required to holistically
meet enhanced environmental criteria and to further improve product quality and safety.
ME EQUIPMENT is intended to have beneficial effects on humans. However if the damage to the
ENVIRONMENT caused by the ME EQUIPMENT outweighs the medical benefits, this is counter-
productive to the intended function of the ME EQUIPMENT. ME EQUIPMENT should be designed,
manufactured, used and discarded in a manner that is environmentally responsible.
The objective of this collateral standard is to reduce the ENVIRONMENTAL IMPACTS of the
ME EQUIPMENT taking into account all the ME EQUIPMENT LIFE-CYCLE stages. Benefits of
implementing this collateral standard include, for example, the reduction of potential sources
of HARM, HAZARDOUS SUBSTANCES and WASTE, and savings of natural resources, raw materials
and energy. Benefits can be grouped into transportation reduction, cost reduction and a
positive public perception of the MANUFACTURER as a good corporate citizen.
LIFE-CYCLE ASSESSMENT is a tool that can be used to reduce the ENVIRONMENTAL IMPACT of ME
EQUIPMENT. The principle and framework for LIFE-CYCLE ASSESSMENT is described in
ISO 14040 [7]. MANUFACTURERS undertaking LIFE-CYCLE ASSESSMENT will have to select or
develop their own PROCESSES and assessment tools to achieve product-related environmental
improvements.
The ENVIRONMENTAL IMPACTS of ME EQUIPMENT are largely determined during the DESIGN AND
DEVELOPMENT stage. Therefore, in order to reduce the adverse ENVIRONMENTAL IMPACTS of the
new ME EQUIPMENT:
– adverse ENVIRONMENTAL IMPACT reduction should be seen as starting at the identification of
need and flowing throughout DESIGN AND DEVELOPMENT;
– it is highly desirable to start the ENVIRONMENTAL ASPECT/IMPACT assessment as early as
possible in product planning.
Typically the ME EQUIPMENT LIFE CYCLE includes the stages in Table A.1. Table A.1 contains
both environmental considerations and, where applicable, examples of ENVIRONMENTAL
ASPECTS for each LIFE-CYCLE stage.
Environmental protection is not a subject that is covered in all engineering training.
Consequently this rationale is more detailed than normal for a standard of this type.
The following is one of many examples of the LIFE-CYCLE stages of ME EQUIPMENT.

– 14 – 60601-1-9 © IEC:2007
Table A.1 – Example product LIFE-CYCLE stages
Stage Activity Characteristics Environmental considerations
Identification of a market need (including It might be possible to meet the identified need
environmental expectations). For example, by solutions not requiring the production of a
Exploration,
market needs can be defined from direct new product. The ENVIRONMENTAL ASPECTS of
identification of
customer demand or market feedback. adapting existing products or non-physical
opportunities and
product solutions (e.g. a time counter can be
management
replaced by a software module or hardware
decision
can be replaced by a service solution) should
be explored.
A solution requiring a product has been Define and assess ENVIRONMENT-related
identified. Comparison of the expected targets. Identify requirements that result from
ENVIRONMENTAL IMPACTS of the proposed these targets. Establish these requirements in
product against previous or competitive the requirement specification (e.g. reduce
products is appropriate. Legal and other energy consumption over the product LIFE
normative information needs to be CYCLE by 20%).
considered.
Requirement
specification
The Requirement specification is created.
The requirement specification should detail
required performance and not propose
specific solutions, so as to allow innovative
and novel approaches.
The project is formalized.
The point at which preliminary solutions to The optimal stage at which to consider creative
the need are explored. Ideas will be solutions to reduce adverse ENVIRONMENTAL
documented informally; the design will be IMPACTS. e.g. consideration can be given to:
very fluid. Up to this point, there has been
– modifying, upgrading, refurbishing
little commitment of time or materials.
existing products
Communications with suppliers are informal
– novel technologies
and exploratory.
– creative design solutions
– alternative material choice (Including
reduction/removal of HAZARDOUS
SUBSTANCES)
– use of recycled materials
– use of recovered components/assemblies
– new production PROCESSES
– alternative energy sources
– PACKAGING
– Reduction/elimination of consumables
Product concept
– Service and maintenance
– Extended durability
– Marketing and promotional materials
– END OF LIFE REUSE/RECYCLING and
material recovery
There might be experimentation with different
configurations so that the design solution with
the optimum balance between product benefit,
performance and ENVIRONMENTAL IMPACT can
be easily and cost-effectively established.
Most appropriate point at which the
assessment of product ENVIRONMENTAL
ASPECTS and ENVIRONMENTAL IMPACTS can be
determined. Strategic suppliers become
involved in the design solutions and start to
become important to the environmental profile
of the ME EQUIPMENT.
Identification of
Planning
need
60601-1-9 © IEC:2007 – 15 –
Table A.1 – Example product LIFE-CYCLE stages (continued)
Stage Activity Characteristics Environmental considerations
Design solution now becoming Establish environmental targets and
established. Information necessary requirements for the design, considering all
to turn the concept into a formal LIFE-CYCLE stages, in the design specification.
product is gathered. Components
The design is refined and incremental
and assemblies are developed or
environmentally beneficial changes can
sourced. Although changes to the
usually be made, especially in the areas of
specification can be made, this now
material reduction and component selection.
starts to incur costs.
Appropriate production PROCESSES should be
considered as these can be a significant
source of adverse ENVIRONMENTAL IMPACTS. All
suppliers start to become integrated into the
development PROCESS and their environmental
performance will have effects on the overall
DESIGN AND
ENVIRONMENTAL IMPACT of the ME EQUIPMENT.
DEVELOPMENT
Consideration must be given to limiting the
amount and number of materials used in the
ME EQUIPMENT. (As a general rule the smaller
and lighter the better, as this has a
subsequent benefit on PACKAGING,
transportation and END OF LIFE as well.)
Efforts should be made to eliminate
HAZARDOUS SUBSTANCES both in the product
and during the production PROCESS.
Where the use of HAZARDOUS SUBSTANCES is
unavoidable ME EQUIPMENT construction and
operation should consider RISKS.
Design now established and major The ENVIRONMENTAL IMPACT of the ME
changes now only possible at great EQUIPMENT design should be confirmed against
Prototype expense. A physical model exists. the assessment documented at the product
testing Testing against the specification will concept stage.
including TYPE have commenced and design will be
Significant deviations from expected results
TESTING validated against original need.
should be investigated.
Representative sample(s) can be
submitted for TYPE TESTING.
Manufactured ME EQUIPMENT Consideration should be given to
subjected to final testing to ensure ENVIRONMENTAL ASPECTS resulting from
Product testing
quality and confirm conformance extreme operating conditions (e.g. as a result
with standards. of safety factor / margin).
The design of the ME EQUIPMENT is Production PROCESS ENVIRONMENTAL ASPECTS
now fixed and is being manufactured (e.g. production WASTE, water usage, energy
to revision controlled drawings and consumption, component logistics, HAZARDOUS
Product
assembly method sheets. SUBSTANCES) should be considered.
manufacturing
SUPPLY CHAIN PROCESSES and work sub-
contracted out should also be considered.

Production Testing Design
– 16 – 60601-1-9 © IEC:2007
Table A.1 – Example product LIFE-CYCLE stages (continued)
Stage Activity Characteristics Environmental considerations
ME EQUIPMENT can be in final Consideration needs to be given to adverse
PACKAGING and is stored pending ENVIRONMENTAL IMPACTS caused by failure of
Storage shipment to RESPONSIBLE the ME EQUIPMENT when stored outside the
ORGANIZATIONS. specified storage conditions, e.g. by bursting a
container that leaks corrosive materials.
ME EQUIPMENT being shipped to Consideration needs to be given to type and
designated sites. reusability of PACKAGING, transportation
method, weight of ME EQUIPMENT and whether
the ME EQUIPMENT can be assembled on site or
shipped assembled. Logistical efficiency can
be enhanced by:
– contracting suppliers / subcontractors to
Product
deliver directly to the RESPONSIBLE
transport
ORGANIZATION / distributor if possible
– by ensuring that packaged ME EQUIPMENT
can stack efficiently in standard generic
transportation containers.
– collecting old products for REUSE,
recovery or RECYCLING.
New ME EQUIPMENT is installed at Although installation is not normally
site prior to being used. environmentally significant, should the product
require substantial quantities of HAZARDOUS
SUBSTANCES (e.g. transformer oil)
consideration has to be given to ease of
transportation and handling of these
Installation
substances, as well as the disposal of any
excess at the end of the installation PROCESS.
The use of specialized mechanical handling or
assembly tools should be avoided where
possible.
Distribution
60601-1-9 © IEC:2007 – 17 –
Table A.1 – Example product LIFE-CYCLE stages (cont
...