Medical Electrical Equipment Test

Electrical and Electronic equipment accounts for over 60% of all conventional medical equipment used in Health facilities. The safety and efficiency of medical electrical devices are controlled by strictly regulated national and international approval procedures. This puts an obligation of manufacturers, purchasers and users to have the equipment tested for evaluating and reducing the risks involved with Medical Devices and their connections to other devices and/or IT networks.

The Medical Electrical Equipment Standard - IEC 60601

IEC 60601 is a harmonised technical standards that ensure the safety of medical electrical equipment, ensuring that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators. This standard has been recognized as a pre-requisite for the commercialisation of electrical medical equipment by public health authorities in many countries.

Our Medical Electrical Equipment Testing

• Safety & Performance Testing

Medical electrical equipment must conforms to the design criteria for electrical safe as set out by the IEC 60601. All tests relating to the electrical safety performance can be categorized into two:

• MEANS OF OPERATOR PROTECTION (MOOP) - Means of protection for reducing the risk of electric shock to persons other than the patient.
• MEANS OF PATIENT PROTECTION (MOPP) - Means of protection for reducing the risk of electric shock to the patient.

Our Medical Electrical Equipment Testing performs safety performance testing according to IEC 60601 standards for medical electrical equipment, and the testing results are provided by test reports and certificates.

• Cyber Security Testing

  With the increasing use of wireless, Internet, and network-connected devices, cyber security has become more important to ensure medical device functionality and safety. Cyber security incidents not only threaten data safety, but lead to patient harm by causing diagnostic or therapeutic errors. Therefore, reducing cybersecurity risks is especially

Our Medical Electrical Equipment Testing provides a full array of cyber security testing services with UL2900 security standard, which has gained international recognition for medical and other connected devices. By identifying threats and vulnerabilities related to cyber security, manufacturers and health care delivery organizations will take exact safeguards to mitigate cyber security risks.

STEMart provides the world-class security testing services in Medical Electrical Equipment Test to support manufacturers to meet the regulatory goals, and minimize the compliance risks.

If you have any additional questions about Medical Electrical Equipment Test or would like to consult with the experts at STEMart, please feel free to contact us.