Safe Current Limits for ANSI/AAMI ES1 Electromedical Apparatus

In the ES1 standard, published jointly by the American National Standards Institute (ANSI) and the Medical Devices Development Association (AAMI), risk limits are determined and test methods are defined for electromedical apparatus intended to be used within the scope of patient care. In addition, limits are set for electromedical equipment that does not come into contact with the patient.

This standard applies to electrical and battery-operated devices and devices used alone or in conjunction with appropriately connected auxiliary equipment. When multiple electromedical equipment is powered by a single power cable, the equipment group is considered a single apparatus for risk limit requirements. The safety and performance criteria defined in this standard are designed to be used in the design qualification by the company producing the device.

The test methods described in the ANSI/AAMI ES1 standard are not used to verify the performance of individual devices in routine quality assurance inspections. It is also permitted to use alternative methods for design qualification, provided that devices tested according to referee methods also meet the requirements of this standard.

However, this standard does not set limits for the combined risk current when several devices perform different functions for the same patient and are independently connected to the mains power system. In addition, this standard does not apply to devices designed primarily for non-medical applications and used with electromedical devices, but located outside the field of patient care.

In short, not all electromedical apparatus are easily covered by this standard. Equipment such as video cassette recorders or computing devices are widely used in healthcare facilities. This type of equipment is designed according to other standards. If these devices are not located in the patient care environment, they do not pose a risk as they are less likely to come into contact with the patient.

For the purposes of this standard, the expression apparatus means an electromedical means equipment that is intended to be electrically connected to this device in order to make the device useful or improve its effectiveness and that is not a modular part of this device.

Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides test services for determining safe current limits for electromedical apparatus, within the scope of ANSI/AAMI ES1 standard, with its trained and expert staff and advanced technological equipment.