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IEC 61010 Testing, Assessment and Certification

Services for electrical equipment used in testing, measurement and laboratories.
Medical device testing

The IEC 61010 series of standards addresses the safety of electrical equipment for laboratory, test and measurement. It also covers nonmeasurement equipment, such as signal generators, transducers, transmitters, power supplies for laboratory use, electrical laboratory equipment used to analyze or prepare materials, and in vitro diagnostic (IVD) equipment.

Types of electrical equipment covered by the IEC 61010 family of standards include:

  • Laboratory equipment, such as stirring apparatus, scales and semiautomatic equipment
  • Specialized laboratory equipment, such as sterilizers (gas, steam or heat), centrifuges and atomic spectrometers
  • Material treatment equipment, such as incubators, environmental chambers, refrigerators and blood storage freezers
  • Measuring equipment, such as probes, measuring circuits, current clamps, multimeters, and dielectric and insulation resistance instruments
  • Inspection equipment, such as X-ray scanning (luggage) units and flaw detectors
  • In vitro diagnostic (IVD) devices
  • Sample analysis equipment

UL 61010-1, the Standard for Safety Requirements for Electrical Equipment For Measurement, Control, and Laboratory Use, and CSA C22.2 No. 61010-1-12 with revisions through June 6, 2023, include additional national differences that clarify the scope of products covered by the standard plus country specific requirements.

Hazards addressed by the IEC 61010 series of standards

Laboratory, test and measurement equipment are not exempt from safety hazards. UL Solutions experts understand the potential hazards of such equipment and are experienced in identifying them throughout the testing process. When examining equipment for possible hazards, some of the basic safety considerations addressed by this standard include:

  • Electric shock and burn
  • Mechanical hazards, including those related to moving parts, stability and loading
  • Spread of fire
  • Excessive temperature
  • Effects of fluids and fluid pressure
  • Radiation (including sound and ultrasound)
  • Liberated gases/chemical
  • Application-related hazards

Clause 17 of IEC 61010-1 requires a risk assessment to be conducted if hazards identified are not fully addressed by the standard.

The standard is based on the use of traditional safety mitigation measures. When the equipment uses a combination of hardware and/or software to mitigate hazards, additional evaluation may be necessary to assess the reliability and effectiveness of those controls.

These considerations provide a baseline for identifying potential hazards in electrical equipment for test, measurement and laboratory use. 

Laboratory equipment component certification program for products under IEC 61010

The IECEE Generic Component Certification Program (CCP) provides a structured pathway for certifying components intended for use within products evaluated to IEC 61010, such as measurement, control and laboratory equipment. Under this program, eligible components — such as internal power supplies, voltage measuring boards, refrigeration subassemblies for IVD equipment and X-ray tube assemblies — are evaluated against applicable end-product standard requirements. Certification is issued in the form of a Component Certificate of Conformity (CCC), supported by an IEC 61010 Test Report Form (TRF).

The CCP is intended for components or subassemblies for which no dedicated component standard exists. When an end-product standard references a separate component standard, a CCC may be issued only if the component is also evaluated to that component standard, unless the applied IEC 61010 requirements are demonstrated to be equal to or more stringent. The test report identifies the clauses applied and outlines any limitations of testing, enabling manufacturers and end-product certifiers to confidently integrate certified components while reducing redundant testing and certification efforts.

Contact us to learn how CCP certification can help streamline compliance for IEC 61010 components. 

Why work with UL Solutions?

Our experts have deep expertise in the evolving standards and regulatory landscape for electrical equipment for test, measurement and laboratory use.

Compliance expectations are defined by a range of stakeholders, including code authorities, retailers, laboratory managers, healthcare facilities managers and code enforcement bodies. Understanding applicable requirements is key to maintaining compliance.

UL Solutions conducts testing to evaluate products for compliance with applicable standards and regulatory requirements.

Testing can help enable:

  • Global market access (within our CB Scheme scope)
  • Documentation for regulatory submissions
  • Evidence to demonstrate conformity with applicable requirements
  • Third-party test data and technical files supporting CE marking
  • In vitro diagnostic (IVD) testing that may contribute to U.S. Food and Drug Administration (FDA) submissions through programs such as the Accreditation Scheme for Conformity Assessment (ASCA)  

Standards

  • IEC/EN/UL/CSA 61010-1, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements
  • IEC/EN/UL/CSA 61010-2-010, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-010: Particular Requirements for Laboratory Equipment for the Heating of Materials
  • IEC/EN/UL/CSA 61010-2-011, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-011: Particular Requirements for Refrigerating Equipment
  • IEC/EN/UL/CSA 61010-2-012, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-012: Particular Requirements for Climatic and Environmental Testing and Other Temperature Conditioning Equipment
  • IEC/EN/UL/CSA 61010-2-020, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-020: Particular Requirements for Laboratory Centrifuges
  • IEC/EN/UL/CSA 61010-2-030, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-030: Particular Requirements for Equipment Having Testing or Measuring Circuits
  • IEC/EN/UL/CSA 61010-031, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 031: Safety Requirements for Hand-Held and Hand-Manipulated Probe Assemblies for Electrical Test and Measurement
  • IEC/EN/UL/CSA 61010-2-032, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-032: Particular Requirements for Hand-Held and Hand-Manipulated Current Sensors for Electrical Test and Measurem
  • IEC/EN/UL/CSA 61010-2-033, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-033: Particular Requirements for Hand-Held Multimeters for Domestic and Professional Use, Capable of Measuring Ma
  • IEC/EN/UL/CSA 61010-2-034, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-034: Particular Requirements for Measurement Equipment for Insulation Resistance and Test Equipment for Electric
  • IEC/EN/UL/CSA 61010-2-040, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials
  • IEC/EN/UL/CSA 61010-2-051, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-051: Particular Requirements for Laboratory Equipment for Mixing and Stirring
  • IEC/EN/UL/CSA 61010-2-061, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-061: Particular Requirements for Laboratory Atomic Spectrometers with Thermal Atomization and Ionization
  • IEC/EN/UL/CSA 61010-2-081, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-081: Particular Requirements for Automatic and Semi-Automatic Laboratory Equipment for Analysis and Other Purpose
  • IEC/EN/UL/CSA 61010-2-091, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-091: Particular Requirements for Cabinet X-Ray Systems
  • IEC/EN/UL/CSA 61010-2-101, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
  • IEC/EN 61326-1 (EMC) - Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements
  • IEC/EN 61326-2-6 (EMC) - Electrical equipment for measurement, control and laboratory use - EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical electrical equipment

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Designing for Compliance to IEC 61010-1 3rd Edition

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