Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2015 is available as IEC 60601-1-11:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and
- harmonizing with the changes to the amendments to the general standard and other collateral standards.

Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme Collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

IEC 60601-1-11:2015 est disponible sous forme de IEC 60601-1-11:2015 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
IEC 60601-1-11:2015 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, destinés à être utilisés dans l'environnement des soins à domicile. Elle s'applique sans distinguer si l'appareil électromédical ou le système électromédicalest prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. L'environnement des soins à domicile comprend:
- l'habitation dans laquelle un patient vit;
- d'autres environnements où des patients sont présents à l'intérieur comme à l'extérieur, à l'exclusion des environnements des établissements de soins où des opérateurs ayant une formation médicale sont disponibles de façon continue lorsque des patients sont présents.
Cette deuxième édition annule et remplace la première édition de l'IEC 60601-1-11, parue en 2010. Cette édition constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes:
- correction de la méthode d'essai pour le contrôle de l'humidité relative à des températures supérieures à 35 °C;
- reformulation des paragraphes qui modifient plus qu'ils ne complètent la norme générale ou d'autres normes collatérales; et
- harmonisation avec les modifications apportées aux amendements de la norme générale et aux autres normes collatérales.

General Information

Status
Published
Publication Date
19-Jan-2015
Current Stage
PPUB - Publication issued
Start Date
20-Jan-2015
Completion Date
20-Jan-2015
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IEC 60601-1-11:2015 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
IEC 60601-1-11:2015-01(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2180-8

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

---------------------- Page: 3 ----------------------
– 2 – IEC 60601-1-11:2015 © IEC 2015
CONTENTS

FOREWORD ........................................................................................................................... 5

INTRODUCTION ..................................................................................................................... 8

1 Scope, object and related standards ................................................................................ 9

1.1 * Scope ................................................................................................................... 9

1.2 Object ..................................................................................................................... 9

1.3 Related standards ................................................................................................... 9

1.3.1 IEC 60601-1 .................................................................................................... 9

1.3.2 Particular standards ....................................................................................... 10

2 Normative references .................................................................................................... 10

3 Terms and definitions .................................................................................................... 11

4 General requirements .................................................................................................... 12

4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and

ME SYSTEMS ........................................................................................................... 12

4.2 * Environmental conditions for ME EQUIPMENT ........................................................ 12

4.2.1 General ......................................................................................................... 12

4.2.2 * Environmental conditions of transport and storage between uses ................ 13

4.2.3 * Environmental operating conditions ............................................................. 14

5 * General requirements for testing ME EQUIPMENT ........................................................... 16

6 * Classification of ME EQUIPMENT and ME SYSTEMS .......................................................... 17

7 ME EQUIPMENT identification, marking and documents .................................................... 17

7.1 * USABILITY of the ACCOMPANYING DOCUMENTS ........................................................ 17

7.2 * Additional requirements for marking of IP classification ...................................... 18

7.3 ACCOMPANYING DOCUMENTS ................................................................................... 18

7.3.1 Contact information ....................................................................................... 18

7.3.2 LAY OPERATOR briefing information ................................................................. 18

7.4 Instructions for use ............................................................................................... 19

7.4.1 Additional requirements for warning and safety notices .................................. 19

7.4.2 * Additional requirements for an electrical power source ................................ 19

7.4.3 Additional requirements for ME EQUIPMENT description .................................... 20

7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE ...................... 20

7.4.5 Additional requirements for operating instructions .......................................... 20

7.4.6 Additional requirements for ME EQUIPMENT messages ..................................... 21

7.4.7 * Additional requirements for cleaning, disinfection and sterilization ............... 21

7.4.8 Additional requirements for maintenance ....................................................... 21

7.4.9 Additional requirements for environmental protection ..................................... 21

7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS ............................ 22

7.5 Technical description ............................................................................................ 22

7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT .............................................. 22

7.5.2 Additional requirements for professional hygienic maintenance ..................... 22

8 Protection against excessive temperatures and other HAZARDS ...................................... 22

8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and

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

8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS.......... 23

8.3 Additional requirements for ingress of water or particulate matter into

ME EQUIPMENT and ME SYSTEMS .............................................................................. 23

8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT ............................. 23

---------------------- Page: 4 ----------------------
IEC 60601-1-11:2015 © IEC 2015 – 3 –

8.3.2 * Ingress of water or particulate matter into ME SYSTEMS ................................ 23

8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to

ME EQUIPMENT and ME SYSTEM ............................................................................... 23

8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE ...................... 24

8.5.1 * Indication of state ........................................................................................ 24

8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs ........................... 25

9 Accuracy of controls and instruments and protection against hazardous outputs ........... 25

10 Construction of ME EQUIPMENT ........................................................................................ 25

10.1 * Additional requirements for mechanical strength ................................................. 25

10.1.1 General requirements for mechanical strength ............................................... 25

10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE

ME EQUIPMENT ................................................................................................ 27

10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE

ME EQUIPMENT ................................................................................................ 28

10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT ............... 29

11 * Protection against strangulation or asphyxiation .......................................................... 30

12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and

ME SYSTEMS ................................................................................................................... 30

13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS ............... 30

13.1 * Additional requirement for generation of ALARM SIGNALS ...................................... 30

13.2 * Additional requirement for ALARM SIGNAL volume ................................................. 30

Annex A (informative) General guidance and rationale ......................................................... 31

A.1 General guidance .................................................................................................. 31

A.2 Rationale for particular clauses and subclauses .................................................... 32

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

and ME SYSTEMS .................................................................................................................... 51

B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ...................... 51

B.2 ACCOMPANYING DOCUMENTS, general ...................................................................... 51

B.3 ACCOMPANYING DOCUMENTS, instructions for use .................................................... 51

B.4 ACCOMPANYING DOCUMENTS, technical description .................................................. 53

Annex C (informative) Symbols on marking .......................................................................... 54

Bibliography .......................................................................................................................... 56

Index of defined terms used in this collateral standard .......................................................... 58

Figure 1 – Small finger probe Ø 5,6 ...................................................................................... 17

Figure A.1 – Saturation water vapour pressure as function of temperature ............................ 36

Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE ............................... 26

Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE ...................................... 27

Table A.1 – Saturation water vapour pressure as function of temperature ............................. 37

Table A.2 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT

ENCLOSURE ingress of water and particulate matter requirements .......................................... 46

Table A.3 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT

subjected to shock and vibration ........................................................................................... 47

Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts ................... 51

Table B.2 – ACCOMPANYING DOCUMENTS, general ................................................................... 51

Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use ................................................. 52

---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-11:2015 © IEC 2015

Table B.4 – ACCOMPANYING DOCUMENTS, technical description ............................................... 53

Table C.1 – General symbols ................................................................................................ 54

---------------------- Page: 6 ----------------------
IEC 60601-1-11:2015 © IEC 2015 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment
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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

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 60601-1-11 has been prepared by a joint working group of

IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice of

IEC technical committee 62: Electrical equipment in medical practice and ISO subcommittee

SC3: Lung ventilators and related devices, of ISO technical committee 121: Anaesthetic and

respiratory equipment.
It is published as a double logo standard.

This second edition constitutes a collateral standard to IEC 60601-1 (third edition, including

Amendment 1): Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance, hereafter referred to as the general standard.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-11:2015 © IEC 2015

This second edition cancels and replaces the first edition of IEC 60601-1-11, published in

2010, and constitutes a technical revision.

The most significant changes with respect to the previous edition include the following

modifications:

– correction of test method for relative humidity control at temperatures above 35 °C;

– redrafting of subclauses that altered instead of adding to the general standard or other

collateral standards; and

– harmonizing with the changes to the amendments to the general standard and other

collateral standards.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/959/FDIS 62A/978/RVD

Full information on the voting for the approval of this collateral standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by

17 P-members out of 17 having cast a vote.

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

In the IEC 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 collateral standard, the term

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

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

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.3.1 are all

subclauses of Clause 7).

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

clause number. References to subclauses within this collateral 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;
---------------------- Page: 8 ----------------------
IEC 60601-1-11:2015 © IEC 2015 – 7 –

– “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.

The committee has decided that the contents of this publication will remain unchanged until

the stability 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.

NOTE The attention of Member Bodies and National Committees is drawn to the fact that equipment

manufacturers and testing organizations may need a transitional period following publication of a new, amended or

revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip

themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this

publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of

publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct

understanding of its contents. Users should therefore print this document using a

colour printer.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-11:2015 © IEC 2015
INTRODUCTION

Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL

SYSTEMS for monitoring, treatment or diagnosis of PATIENTS in the HOME HEALTHCARE

ENVIRONMENT (see 3.1). The safety of MEDICAL ELECTRICAL EQUIPMENT in this uncontrolled

environment with regard to the electrical installation and its related safety and protection

means is a cause for concern.

The potential lack of training of the LAY OPERATOR and possibly of those supervising the use of

the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM and their level of education

need to be addressed in the development of the ACCOMPANYING DOCUMENTS and in the

relevant marking on the equipment itself so that this material can be understood. This

collateral standard gives special guidance on how this should be addressed in the instructions

for use.

This collateral standard was developed with contributions from clinicians, engineers and

regulators. The terminology, requirements, general recommendations and guidance of this

collateral standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL

EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for the

development of particular standards.
---------------------- Page: 10 ----------------------
IEC 60601-1-11:2015 © IEC 2015 – 9 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used
in the home healthcare environment
1 Scope, object and related standards
1.1 * Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME

HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the

instructions for use. This International Standard applies regardless of whether the

ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare

personnel.
The HOME HEALTHCARE ENVIRONMENT includes:
– the dwelling place in which a PATIENT lives;
– other places where PATIENTS are present both indoors and outdoors, excluding

professional healthcare facility environments where OPERATORS with medical training are

continually available when PATIENTS are present.

This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely

for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or

solely for use in professional healthcare facilities covered by IEC 60601-1 without the

additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or

ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for

use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard.

EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the

professional healthcare facility environment.

NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with

unreliable electrical sources and poor electrical grounding.
1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to

those of the general standa
...

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