A new edition of IEC 61010-2-101 has been published to bring the specifications of IVD analyzers up to date, in line with new regulatory requirements.
The market for in vitro diagnostic (IVD) devices is on an upward trend, driven by an aging population and rising rates of obesity and chronic disease. According to research consultancy GlobalData Healthcare, the market is expected to generate revenues of USD 69 billion by 2024. The market for self-testing kits is a case in point.
“The self-testing devices are mostly used for monitoring diabetes levels and have been around for a number of years. As the number of people suffering from diabetes is growing around the world, the demand for such appliances is increasing,” says Holger Pufahl, the Convenor of the IEC maintenance team (MT) which led the work on the new edition.
New technologies such as molecular testing are also driving growth. Molecular diagnostics involve a collection of techniques used to analyze biological markers in the individual’s genetic code. These tests are increasingly used by oncologists, for instance.
The IEC 61010-2 family of standards deals specifically with laboratory equipment safety. It covers heating and sterilization devices, as well as radiation equipment, centrifuges and IVD analyzers. These publications are part of the wider IEC 61010 series which specifies safety requirements for electrical and electronic equipment used for test and measurement purposes.
“The reason we initially decided to draft a separate standard for IVD equipment was to comply with EU legislation. The first IVD directive was published in 1998, which led to the initial standard. A more recent one was issued in 2017 which prompted a new version,” Pufahl explains.
The standard is available in a red line version, meaning that the changes with the previous edition are highlighted in red.