Safety Testing of Sterilizers and Washer-Disinfectors according to IEC 61010-2-040

Sterilizers and washer-disinfectors are critical devices in healthcare and laboratory environments, where safety and reliability are essential. The IEC 61010-2-040 standard defines the particular safety requirements for equipment used to treat materials by chemical and thermal processes.

Key requirements focus on protection against high temperatures, pressurized systems, hazardous chemicals, and risks related to fluid handling. Testing typically covers aspects such as leakage, mechanical strength, abnormal operation, and protection against operator exposure to heat and chemicals. A major challenge lies in addressing multiple interacting hazards within a single system, requiring a comprehensive safety approach.

Manufacturers often face difficulties in demonstrating compliance under realistic operating conditions, especially when designing compact systems with complex process cycles. Another challenge is ensuring durability and consistent performance under aggressive environments, such as exposure to steam, disinfectants, and corrosive substances.

Testing is essential not only for regulatory compliance, but also for ensuring operator safety, reducing liability, and enabling global market access.

SIQ is accredited for testing according to IEC 61010-2-040 and have this standard also within our CB Scheme scope, enabling efficient and internationally recognized certification.

We support our customers with:

• early design reviews and gap analysis,
• pre-compliance and full safety testing,
• certification support for international markets.

Applicable standards:

• IEC 61010-1:2010 + A1:2016
• EN IEC 61010-1:2010 + A1:2019
• IEC 61010-2-040:2020
• EN IEC 61010-2-040:2021

More information:
Matej Šmidovnik
E-mail: matej.smidovnik@siq.si
Tel.: +386 1 4778 267