IEC 60601-1 is the basic safety standard for medical electrical devices and systems. It is a risk-based standard.
The IEC 60601-1 standard is essential for manufacturers or repair shops of electrically operated medical devices. The standard covers an essential part of compliance with the EU MDR and FDA requirements.
By meeting the requirements of IEC 60601-1, a medical device meets the requirements for Basic Safety. This means that when the device is operating in normal condition or has a single fault condition, there are no hazards that would cause unacceptable risk to the patient or user.
By meeting the requirements of the standard, a medical device also meets the requirements for Essential Performance. This refers to the performance of a clinical function other than basic safety, where loss or degradation beyond the specific limits causes an unacceptable risk.
The IEC 60601-1 standard includes 420 pages and covers, e.g.:
– Testing the equipment
– Classification of the equipment (IEC 60601-1 classification)
– Identification, marking and documents
– Electrical safety
– Usability
– Radiation
– Software and systems
– Construction of the equipment
– Electromagnetic compatibility
The standard is a harmonized standard to the Medical Device Directive. It will be harmonized to the Medical Device Regulation ETA in 2024 as EN 60601-1
The standard includes references to particular and collateral standards.
IEC 60601-1 training
Labquality provides IEC 60601-1 standard training, during which you will learn about the basic safety and essential performance of the standard, its content and requirements. Although the training mainly covers medical devices, it also briefly addresses IVD device safety standard 61010-1.
The training starts with a part that is not safety standard specific but describes the standardization organizations, international and regional (EU, USA, Canada), how the standards are created and how they are implemented in the regulations.
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