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IEC 60601-1-11 Home Health Care Testing

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 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. IEC 60601 1 11 and EN 60601 1 11 testing gives special guidance on how this should be addressed in the instructions for use.

IEC 60601-1-11 was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of EN 60601-1-11 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.

Keystone Compliance assists manufacturers with IEC 60601-1-11 and EN 60601-1-11 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-11 test lab needs.