IEC 60601-1-11:2010

IEC 60601-1-11
Edition 1.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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IEC 60601-1-11
Edition 1.0 2010-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040 ISBN 978-2-88910-920-3

– 2 – 60601-1-11 © IEC:2010
CONTENTS
FOREWORD.4
INTRODUCTION.7
1 Scope, object and related standards.8
1.1 * Scope .8
1.2 Object .8
1.3 Related standards .8
1.3.1 IEC 60601-1 .8
1.3.2 Particular standards .8
2 Normative references .9
3 Terms and definitions .9
4 General requirements .11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS.11
4.2 Environmental conditions for ME EQUIPMENT.11
4.2.1 * Environmental conditions of transport and storage between uses.11
4.2.2 * Environmental operating conditions.12
4.2.3 * Environmental shock to TRANSIT-OPERABLE ME EQUIPMENT.13
5 * General requirements for testing ME EQUIPMENT .14
6 * Classification of ME EQUIPMENT and ME SYSTEMS.15
7 ME EQUIPMENT identification, marking and documents.15
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS .15
7.2 * Additional requirements for marking of IP classification.16
7.3 ACCOMPANYING DOCUMENTS.16
7.3.1 Contact information .16
7.3.2 LAY OPERATOR briefing information.16
7.4 Instructions for use.17
7.4.1 Additional requirements for warning and safety notices.17
7.4.2 * Additional requirements for an electrical power source .17
7.4.3 Additional requirements for ME EQUIPMENT description .18
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE .18
7.4.5 Additional requirements for operating instructions.18
7.4.6 Additional requirements for ME EQUIPMENT messages.18
7.4.7 * Additional requirements for cleaning, disinfection and sterilization .19
7.4.8 Additional requirements for maintenance .19
7.4.9 Additional requirements for environmental protection.19
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS.20
7.5 Technical description.20
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT .20
7.5.2 Additional requirements for professional hygienic maintenance .20
8 Protection against excessive temperatures and other HAZARDS .20
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS .20
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS .20
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS .21
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT.21

60601-1-11 © IEC:2010 – 3 –
8.3.2 * Ingress of water or particulate matter into ME SYSTEMS .21
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM.21
9 Accuracy of controls and instruments and protection against hazardous outputs .22
10 Construction of ME EQUIPMENT .22
10.1 * Additional requirements for mechanical strength .22
10.1.1 General requirements for mechanical strength.22
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT .24
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT .25
10.2 * Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE .26
10.3 Additional requirements for actuating parts of controls of ME EQUIPMENT .27
11 * Protection against strangulation or asphyxiation.27
12 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .27
12.1 Emissions classification.28
12.2 Protection of the PUBLIC MAINS NETWORK .28
12.3 * Additional technical description requirements applicable to ME EQUIPMENT
and ME SYSTEMS .28
12.4 * Additional requirements applicable to ME EQUIPMENT and ME SYSTEMS
specified for use only in a shielded location.28
12.5 * Additional requirements for ELECTROSTATIC DISCHARGE (ESD) tests.28
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS .28
13.1 * Additional requirement for generation of ALARM SIGNALS .28
13.2 * Additional requirement for ALARM SIGNAL volume .29
Annex A (informative) General guidance and rationale.30
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS .49
Annex C (informative) Symbols on marking.53
Bibliography.54
Index of defined terms used in this collateral standard.56

Figure 1 – Small finger probe ∅ 5,6 .15

Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE .23
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE .24
Table A.1 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
ENCLOSURE ingress of water and particulate matter requirements.42
Table A.2 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
subjected to shock and vibration .43
Table B.
...