DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
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
