Clean bill of health

Setting the safety requirements for in vitro diagnostic devices

By Catherine Bischofberger

A new edition (IEC 61010-2-101) of a best-selling International Standard fills a gap and meets manufacturer requirements for the safety of medical equipment. There is no other equivalent.

diabetes self testing kit The number of people with diabetes is growing and so is the demand for self-testing kits

Ahead of the game

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 demand for self-testing kits is a case in point. These IVD appliances are used for the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes.

“The self-testing devices are mostly used for monitoring diabetes and have been around for a number of years. But as the number of people suffering from diabetes is growing around the world, the demand for these devices is increasing”, says Holger Pufahl, who led 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.

Health and safety go hand in hand: hospital and labs, in particular, have to make sure they comply with the strictest safety regulations. IEC prepares International Standards for the safety of measuring, control and laboratory equipment, which among other things, apply to laboratory equipment used in the analysis, handling and preparation of materials. These specifications apply to areas such as research, medicine, industry, education and environmental monitoring.

“Many IVD device manufacturers are medium-sized companies which spend a lot of money to develop the right medical equipment and make sure it is safe. They need to export IVD devices all around the world to recoup their initial investment. Meeting the Standard’s specification is a way of ensuring their products can be sold on a worldwide basis”.

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 of Standards which specifies safety requirements for electrical and electronic equipment, essentially used for test and measurement purposes. This group of safety publications sets out the procedures for the preparation of these Standards.

Regulations are a key driver

A new publication IEC 61010-2-101, brings the specifications for IVD analyzers up to date, whether they are used for clinical chemistry, immunochemistry, haematology, microbiology, nucleic acid probe systems or self-test equipment.

“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 published in 2017, which prompted a new version”, says Pufahl.  According to the EU 2017/746 Regulation, “there are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence which require the adoption of specific legislation, distinct from the legislation of other medical devices”.

The rise in chronic illnesses will pose growing challenges for medical facilities, whether hospitals or labs. Making sure testing equipment for these chronic illnesses respect International Standards is one step in the right direction.

Gallery
Holger Pufahl Holger Pufahl, Convenor of MT 10 (TC 66)
diabetes self testing kit The number of people with diabetes is growing and so is the demand for self-testing kits