Medical electrical equipment and systems

Medical electrical equipment and systems are an essential part of any hospital or medical office. They play a vital role in both the diagnosis and treatment of patients. And because these devices are so important, it’s essential that they’re maintained and operated in a safe and reliable way. That’s where our team at e-Steward come in. We offer a wide range of services related to medical electrical equipment and systems, including on-site inspections and repairs. We know that these devices are essential to the health and safety of patients, so we work hard to ensure that they stay that way. If you’re looking for quality medical electrical equipment and systems maintenance, look no further than e-Steward.

EN 60601 and CE marking

Medical electrical equipment and systems must meet the EN 60601 and CE marking regulations in order to ensure safe use. The EN 60601 standard specifies general requirements for all electrical equipment used in medical settings, while the CE marking ensures that medical electrical equipment is made from safe and reliable materials.

To meet the IEC60601-1 testing  standard, medical electrical equipment must be designed for use in a hospital environment. This includes devices that are used to monitor patient health, such as electrocardiographs (ECGs), ventilators, and scales. To meet the CE mark, medical electrical equipment must be free of harmful substances and components. This means that devices using electricity must not produce toxins when they're turned on, and any parts that come into contact with the body must be safe to use.

In addition to meeting safety standards, medical electrical equipment must also be easy to operate. Devices should have clearly marked buttons or controls, and instructions should be available in both English and French. Furthermore, all medical electrical equipment should be registered with a certification body like Intertek. Registration allows hospitals to track their inventory and make sure that all devices are up to date with latest safety standards

What is EN 60601 Standard?

The EN 60601 Standard is the European standard for medical electrical equipment and systems. This standard defines the requirements for safety, performance, environmental impact, and quality of medical electrical equipment and systems. The standard covers a wide range of medical devices and systems, from cardiac pacemakers to infusion pumps.

One of the key benefits of using a EN 60601-certified medical device is that it will be able to operate in more than 150 countries worldwide. This makes it a popular choice for hospitals and healthcare providers who need to ensure that their devices are compatible with a variety of patient populations. In addition, using an EN 60601-compliant device can help to improve safety standards within healthcare facilities by ensuring that all equipment is compliant with the same set of requirements.

If you are looking for a medical electrical equipment or system that meets the highest possible standards, then you should consider using an EN 60601-certified model.

Complying with EN 60601-1 Standard

Medical electrical equipment and systems are subject to electrical safety requirements set by the European Union (EU) in EN 60601-1 Standard.

The standard is written to protect patients, healthcare workers, and other members of the public from potential electric shock hazards. It sets out specific safety requirements for medical electrical equipment, including voltage limits, current ratings, insulation thicknesses, cord layouts and termination methods.

All medical electrical equipment must be tested and certified to meet the standard's safety requirements before it can be used in a hospital or clinic. certification can be obtained through an accredited medical device testing laboratories.

Ensure that your medical equipment meets all of EN 60601-1 Standard's safety requirements by using an accredited testing laboratory to certify it.

For more information, please visit the EN 60601-1 website or contact your local accredited testing laboratory.