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IEC 60601-1-6 Usability Testing Medical electrical equipment

IEC 60601-1-6 Medical Electrical Equipment Safety Testing

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

Medical practices are progressively adopting electrical equipment for the observation and treatment of patients. Sadly, the usability of these devices has emerged as a growing concern. Errors frequently occur when medical electrical equipment lacks user-friendliness. Much of medical electronic equipment developed without applying a usability engineering process are non-intuitive, difficult to learn and to use.

Keystone Compliance is an ISO 17025-certified product safety testing laboratory. Our experienced engineers understand the challenges and guide companies throughout the entire process.

Summary of IEC 60601-1-6 Medical Device Safety Testing

As healthcare evolves, less skilled operators including patients themselves are now using medical electrical equipment while the medical electrical equipment itself is becoming more complicated. In simpler times, the operator of the medical electrical equipment might be able to cope with an ambiguous, difficult-to-use operator-equipment interface. The design of usable medical electrical equipment is a challenging endeavor. The design of the operator-equipment interface to achieve adequate (safe) usability requires a very different skill set than that of the technical implementation of that interface.

The IEC 60601-1-6 standard offers a framework for manufacturers. It ensures their medical electrical equipment, known as ME equipment, achieves high standards of product safety and effectiveness through focused usability practices.

Furthermore, IEC 60601-1-6 details a comprehensive process for analyzing, planning, developing, and evaluating the usability of ME equipment, particularly in relation to product safety and essential performance. This usability engineering process is crucial for identifying potential usability challenges, although it does not directly address or correct risks associated with improper use.

Successful adherence to the usability engineering guidelines set forth in IEC 60601-1-6 implies that the product’s usability, safety, and performance are considered satisfactory unless proven otherwise by objective evidence, which may emerge from post-production monitoring.

Scope of IEC 60601-1-6

At its Auckland meeting in 2008, IEC Technical Committee 62 approved a project to revise IEC 60601-1-6 so that it would reduce or eliminate duplication with IEC 62366 and also create a bridge between IEC 60601-1 and IEC 62366.

This third edition of IEC 60601-1-6 creates that bridge and will enable a manufacturer to conform to the requirements in IEC 60601-1:2005 that make normative reference to IEC 60601-1-6 by employing a usability engineering process complying with IEC 62366:2007.

At a point in the future, that bridge can be eliminated by revising or amending IEC 60601-1 to include a direct reference to IEC 62366 and, as necessary, adding any additional requirements that are specific to medical electrical equipment, such as those contained in Clauses 4 and 5 of this collateral standard, to IEC 60601-1 or as a normative annex to IEC 62366.

IEC 60601-1-6 testing is intended to be useful not only for manufacturer(s) of medical electrical equipment but also for technical committees responsible for preparing particular medical electrical equipment standards. It should be noted that clinical investigations conducted according to ISO 14155-1 and usability testing for verification or validation according to this standard are two fundamentally different activities and should not be confused.

Relation to Other Standards

  • IEC 60601-1: This foundational standard is augmented by IEC 60601-1-6, which focuses on enhancing the safety and usability of ME equipment. The terms “the general standard” refers to IEC 60601-1 exclusively, “this collateral standard” refers specifically to IEC 60601-1-6, and “this standard” denotes the combination of both, ensuring comprehensive coverage of safety, performance, and usability.
  • Specific Standards: Where applicable, specific standards take precedence over the guidelines provided in IEC 60601-1-6, ensuring that product safety and usability are tailored to the particular needs of different types of ME equipment.

Expert IEC 60601-1-6 Medical Device Product Safety Testing

Keystone Compliance assists manufacturers with IEC 60601-1-6 and EN 60601-1-6 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-6 test lab needs.

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