Abstract

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. Electrical equipment/systems provides a connection to a particular supply main. This equipment/system is intended for use of diagnose, treat, or monitor the patient and makes physical or electrical contact with the patient and/or transfers energy to or from the patient and/or detects such energy transfer to or from the patient The object of this Standard specifies general requirements for the safety and essential performance of medical electrical equipment and serve as the basis for the safety requirements of Particualar standards. Hazards inherent in the intended physiological function of medical electrical equipment and systmes within the scope of this standard are basicly not covered by specific requirement in this standard. This standard can also be applied to equipment used for compensation or alleviation of disease, injury, or disability. It does not apply to in vitro diagnostic equipment or to the implantable parts of active implantable medical devices.

Begin

2004-03-12

Planned document number

IEC 62A/449/CDV

Responsible national committee

DKE/K 811 - Allgemeine Bestimmungen für elektrische Einrichtungen in medizinischer Anwendung  

Responsible international committee

IEC/SC 62A - Common aspects of electrical equipment used in medical practice