Keeping diagnostic instruments safe around human specimens

IEC 61010-2-101:2018 sets particular safety requirements for electrical equipment intended for in vitro diagnostic medical use. In vitro examination takes place outside the body, using human specimens such as blood or tissue. This part of the IEC 61010 family is used with IEC 61010-1:2010+A1:2016, rather than as a standalone safety specification.

Intended use determines the route. An instrument does not become an IVD device simply because it sits in a hospital laboratory. General automated analysis equipment is addressed by IEC 61010-2-081; equipment specifically intended by its manufacturer for IVD examination is assessed under Part 2-101. The scope also includes self-testing IVD equipment for lay users at home.

The third edition, published in 2018, replaced the 2015 edition. Its principal changes align it with Amendment 1 to the general standard and add a tolerance concerning the stability of AC voltage test equipment. When reviewing laboratory equipment safety, check the actual editions recorded in the report.

Follow the specimen, not just the power cable

Biological and chemical hazards can arise along the sample path, at loading positions or in waste collection. A sound electrical enclosure does not by itself contain a specimen leak or a reagent spill. The standard distinguishes a loading zone, where the operator handles samples or reagents, from a sample zone, where operator access is normally unintended. Handling specimens outside the equipment is excluded from this part and needs the laboratory's applicable biosafety procedures.

Electrical protection involves the supply, insulation, accessible parts and protective earthing where applicable. The suitability of equipment used for electric strength testing and the test results for the diagnostic instrument are separate matters. A certified power module does not establish compliance of the complete instrument.

Moving mechanisms introduce another set of risks. A sample transport system or pipetting arm may expose a user to crushing, puncture or contaminated sharp parts. Compliance of an individual control component does not establish the safety of the complete mechanism and its guards.

The instrument's functions can introduce additional hazards. Assess sample heating, refrigeration, mixing mechanisms and centrifuge functions where they are present. Other applicable IEC 61010-2 parts may need consideration. These parts are not automatically required for every IVD instrument.

A broken tube reveals several risks at once

Illustrative scenario: A tube breaks inside an automated carrier and the mechanism jams. Consider whether a user can reach moving parts, whether broken glass or contaminated tips can cause injury, and whether liquid can reach electrical sections. A generic “restart the instrument” message does not explain those hazards. The manufacturer's instructions need to define the safe response to the relevant malfunction.

ISO 14971 risk management provides a process for identifying hazards, assessing risks, implementing controls and monitoring their effectiveness. The useful question is which design or operating measure reduces the identified risk, with evidence that the measure works.

Cleaning and service arrangements matter

Instructions need to address applicable spills, container breakage, jams, cleaning, decontamination and hazardous waste. Use the manufacturer's specified compatible materials and methods. Decontamination reduces contamination-related hazards; it does not necessarily mean sterilisation. Sterilisers and washer-disinfectors have their own equipment safety requirements.

A practical manufacturer example: The Biohit GP Reader NT user guide requires decontamination before a used reader is shipped for service. That illustrates how contamination risks extend to transport and maintenance. It does not prescribe a universal disinfectant or procedure for other instruments. Follow the relevant instrument's instructions and the institution's procedures.

Safety evidence and diagnostic performance answer different questions

Assessment to IEC 61010-2-101 does not replace validation of a diagnostic test's performance. For electromagnetic disturbances, IEC 61326-2-6:2025 addresses basic safety and essential performance of IVD medical electrical equipment. IEC 61326-1 provides the relevant general EMC framework. Passing equipment safety tests does not demonstrate every performance claim under electromagnetic disturbance.

Related reading

References and sources

IEC 61010-2-101:2018 — particular safety requirements for IVD equipment
IEC 61010-1:2010+AMD1:2016 — general safety requirements
IECEE TRF 61010-2-101D:2019 — corresponding test report form
IEC 61326-2-6:2025 — EMC for IVD equipment
ISO 14971:2019 — risk management for medical devices
Biohit GP Reader NT — manufacturer's operating, cleaning and service instructions