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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 test and measurement. It also covers non-measurement equipment such as signal generators, transducers, transmitters, power supplies for laboratory use, electrical laboratory equipment used for analyzing or preparing 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, semiautomatic equipment.
  • Specialized laboratory equipment such as sterilizer (gas/steam/heat), centrifuge, atomic spectrometers.
  • Material treatment equipment such as incubators, environmental chambers, refrigerator, blood storage freezers.
  • Measuring equipment such as probes, measuring circuits, current clamps, multi-meters, dielectric and insulation resistance instruments.
  • Inspection equipment such as x-ray scanning (luggage) units, flaw detector.
  • In-Vitro diagnostic devices.
  • Sample analysis equipment.

UL 61010-1, 3rd Ed and CSA C22.2 No. 61010-1-12 with revisions through June 6, 2023 include additional national differences that includes clarification of scope of products covered by the standard.

Hazards addressed by the IEC 61010 series of standards

Laboratory, test and measurement equipment are not exempt from safety hazards.

Our experts understand the potential hazards of such equipment and are experienced in spotting them throughout the testing process. When examining equipment for possible hazards, some of the basic safety considerations included in this standard are noted below:

  • Electric shock and burn.
  • Mechanical (including moving parts hazards, stability hazards, loading hazards, etc.).
  • Spread of fire.
  • Excessive temperature.
  • Effects of fluids and fluid pressure.
  • Radiation - sound/ultrasound.
  • Liberated gases/chemical.
  • Hazards from application.

Clause 17 of IEC 61010-1 specifically requires a risk assessment to be conducted if examinations of the equipment shows hazards not fully addressed by the standard.

The standard is written around the use of traditional safety mitigation devices. When the equipment employs a combination of hardware and/or software to mitigate on hazards noted above, additional requirements may be necessary to evaluate the hardware and/or software.

These considerations serve as a baseline of potential hazards with electrical equipment for test, measurement and laboratory use.

Why partner 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 is required by most authorities having jurisdiction (AHJ), retailers, laboratory managers, healthcare facilities managers and code enforcement.

To keep your equipment and facility compliant with the requirements, it is important to understand current regulations that apply to your equipment. We conduct testing to ascertain if your product complies to the applicable standards and regulations.

Testing can help you with:

  • Mitigating product liability.
  • Global market access (in our CB Scheme scope).
  • Evidence of meeting regulatory requirements.
  • CE marking support - 3rd party test data and supporting technical files.
  • Protection of health & commercial professionals.
  • In vitro diagnostic (IVD) support for FDA by the ASCA program.

Standards

  • IEC/EN/UL/CSA 61010-1
  • IEC/EN/UL/CSA 61010-2-010 (heating of materials)
  • IEC/EN/UL/CSA 61010-2-011 (refrigeration)
  • IEC/EN/UL/CSA 61010-2-012 (climatic and environmental testing and other temperature conditioning equipment)
  • IEC/EN/UL/CSA 61010-2-020 (centrifuge)
  • IEC/EN/UL/CSA 61010-2-030 (measuring and testing circuits)
  • IEC/EN/UL/CSA 61010-031 (test probes)
  • IEC/EN/UL/CSA 61010-2-032 (hand-held current clamp)
  • IEC/EN/UL/CSA 61010-2-033 (multimeters)
  • IEC/EN/UL/CSA 61010-2-034 (insulation resistance and electric strength equipment)
  • IEC/EN/UL/CSA 61010-2-040 (sterilization)
  • IEC/EN/UL/CSA 61010-2-051 (mixing and stirring)
  • IEC/EN/UL/CSA 61010-2-061 (atomic spectrometers)
  • IEC/EN/UL/CSA 61010-2-081 (automatic and semi-automatic equipment)
  • IEC/EN/UL/CSA 61010-2-091 (cabinet x-ray equipment)
  • IEC/EN/UL/CSA 61010-2-101 (In Vitro Diagnostic (IVD) equipment)
  • IEC/EN 61326-1 (EMC)
  • IEC/EN 61326-2-6 (EMC)

Online Course

Designing for Compliance to IEC 61010-1 3rd Edition

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Medical Testing Services Overview Brochure (English)

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