BS EN 60601-1-11 constitutes a collateral standard to BS EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance.
Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the home healthcare environment.
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. The ‘instructions for use’ in BS EN 60601-1-11 give special guidance on how this should be addressed.
BS EN 60601-1-11 was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this 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.
BS EN 60601-1-11 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 all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned.
Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.
Additional requirements for ingress of water or particulate matter into ME equipment and ME systems
IEC 61125:2018
EN 60335-2-61:2003
EN 60601-1-11:2010
IEC 60601-1-11:2010