DIN EN 60601-1-2:2016-05

This Collateral Standard from the series of standards specifies the electromagnetic disturbances for medical electrical equipment and medical electrical systems. These devices and systems shall comply with the described safety and performance characteristics without interfering with other devices and systems in the electromagnetic environments in which they can be used according to the manufacturer. The application of electromagnetic (interference) emission standards is particularly important for the protection of: - security services; - other medical electrical equipment and medical electrical systems; - electrical equipment other than ME equipment (for example, computers); - telecommunications equipment (for example, radio/television receivers, telephones, radio navigation). Previous editions of this Collateral Standard allowed manufacturers to apply lower immunity test levels. This is no longer the case within the five electromagnetic environment categories defined in this Collateral Standard. This edition also includes a new informative annex with guidance on achieving immunity in terms of electromagnetic compatibility (EMC) or EMC operational performance. For practical reasons, not all phenomena of electromagnetic interference are considered. Manufacturers of medical electrical equipment and medical electrical systems shall consider this in the risk assessment process and assess whether other electromagnetic interference phenomena may make their product unsafe. Guidance on how to consider electromagnetic interference issues in the risk management process is also included. This Collateral Standard is based on existing IEC standards prepared by SC 62A, TC 77 (Electromagnetic compatibility between electrical equipment including power systems), ISO (International Organization for Standardization) and CISPR (International Special Committee on Radio Interference). The responsible committee is DKE/UK 811.2 "Elektromagnetische Verträglichkeit medizinischer elektrischer Geräte und/oder Systeme" ("Electromagnetic compatibility of medical electrical equipment and/or systems") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.