Electrical Safety Testing for Medical Devices & IVDs

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IEC 60601 for Medical Devices

The general safety standard for electrical equipment used for measurement, control, and laboratory purposes is IEC 61010-1.

About IEC 60601-1 (Edition 3.2) 

Technical standards known as IEC 60601 are used to guarantee the security of electrical medical equipment. To ensure that no single electrical, mechanical, thermal, or functional failure should represent an unacceptable risk to patients and/or operators, IEC 60601-1 (Edition 3.2) deals with the fundamental safety and essential performance standards of medical electrical equipment. It is anticipated that IEC 60601-1 (Edition 3.2) is recognised by public health authorities in many nations as a requirement for the commercialization of electrical medical equipment. The most recent general standard with roughly 1500 single specific requirements is IEC 60601-1 (Edition 3.2). The requirements, which must be met in various marketplaces all over the world, are frequently recognised as State-Of-The-Art (SOTA).

IEC 60601-1 (Edition 3.2) is likely to gain acceptance as a norm in the United States, Canada, the EU, Japan, Brazil, Russia, and Australia. The state-of-the-art (SOTA) criteria for such equipment must be taken into account by several major import countries and regions (such as the EU and Australia), which is why newer IEC/ISO standards cannot be disregarded once their customary transition period of 3–4 years has passed. Manufacturers should make sure that their products adhere to both Edition 3.1 and 3.2 of the standard in order to prevent having their products rejected from these and other markets.

IEC 61010 for IVD Medical Electrical Equipment

The general safety standard for electrical equipment used for measurement, control, and laboratory purposes is IEC 61010-1.

Laboratory electrical equipment includes

  • Equipment that prepares materials or measures, signals, monitors, inspects, or analyses materials

  • Instruments for in vitro diagnosis (IVD), including those used for self-tests at home

  • Inspection tools to be used to look individuals or cargo over while being transported

The IEC 61010-1 standard specifies criteria for electrical dangers, mechanical hazards, spreading fire from equipment, laser sources, and sonic and ultrasonic pressure, among other things. For in vitro diagnostic (IVD) medical reasons, including self-test IVD medical purposes, the standard IEC 61010-2-101 is also applicable. In addition to the general standard, this standard provides additional product-specific requirements for in vitro diagnostic (IVD) medical equipment, such as biohazards and hazardous chemical substances.

Artixio's Services

We administer some of the most advanced test facilities in the world, which can evaluate items for electromagnetic compatibility, environmental impact, and electrical safety and performance.

The teams at Artixio have a thorough awareness of both international standards and the field of medical health services. The professionals at Artixio are proficient in sophisticated medical device assessments for functional and software safety, particularly related to vital performance, in addition to regulatory and quality assurance skills.

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