Itoro Udofia, Director, Medical Health Service at TÜV SÜD, explores IEC 60601 and the challenge it brings to medical device manufacturers.
MEDICAL ELECTRICAL EQUIPMENT SAFETY
IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. It is relevant to manufacturers of medical electrical equipment and systems, and those that manufacture components of medical electrical equipment. The standard series includes, but is not limited to, requirements regarding electrical hazards, mechanical hazards, the spread of fire from the equipment, as well as laser sources and sonic and ultrasonic pressure. It is also applicable for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
The rapid technological changes in medical equipment have necessitated prompt revisions to safety standards. The second amendment to the third edition of the medical standard (IEC 606011, Edition 3.2) improved the previous version as it revised outdated references, provided more definitions, and clarified technical issues that manufacturers may have experienced with previous versions.
IEC 61010-1 is the general standard for safety requirements for electrical equipment for measurement, control and laboratory use. Electrical equipment for laboratory refers to:
• Equipment that measures, indicates, monitors, inspects, or analyses materials, or is used to prepare materials
• In vitro diagnostic (IVD) equipment including self-test IVD equipment to be used in the home
• Inspection equipment to be used to check people or material during transportation
Edition 3.2 has around 1,500 single specific requirements. It deals with the general requirements concerning basic safety and essential performance for medical electrical equipment and systems, and serves to ensure that, in both normal conditions and fault conditions, no single electrical, mechanical, thermal or functional failure shall pose an unacceptable risk to patients and/or operators. E.g. related to electrical, mechanical, thermal and functional hazards.
Edition 3.2 includes updates in the areas of risk management, software and usability, use of power supply units, use of safety signs, indicator lights and alarm indicators, maximum overcurrent protection, insulation components, testing & measuring, components that may pose a threat, mechanical and thermal hazards, lasers and optical radiation, ME systems, and EMC planning.
Regulatory bodies across key markets require compliance to IEC 60601, with countries and regions such as the USA, Europe and Asia requiring medical devices to comply with the standard before manufacturers can launch these products in their markets. The requirements are often recognised as State-Of-The-Art (SOTA), which means that for medical devices, this is what is currently accepted as good practice in technology and medicine, not necessarily the most technologically advanced solution.
Manufacturers therefore have to take into account SOTA during the design and construction phase. During
the following production phase, manufacturers have to take into account all changes in standards and scientific knowledge (SOTA) within the framework of their risk management system, until no more new products are placed on the market. The risk management approach requires manufacturers to recognise new internal standards as part of new scientific knowledge. As a minimum, manufacturers have to conduct a gap analysis if new harmonised standards are issued, or new scientific knowledge is available. Gap analysis means retesting, reevaluation and, if necessary, redesign of the medial device.
Medical device manufacturers must also be aware of the varying regulatory transition periods worldwide for IEC 60601-1, Edition 3.2 and navigating the requirements across different markets can therefore be complicated. For example, a transition period of three to four years has been given in most countries and regions, so these
transition periods are not set as a standard period of time across all countries. However, it is also possible that some countries will require standard compliance with the predecessor standard (Edition 3.1) for a longer time.
IEC 60601-1 is a widely accepted standard in the U.S., Canada, the EU, Japan, Brazil, Russia and Australia. To avoid being denied entry into these and other markets, manufacturers with the goal to go worldwide on the market should therefore ensure that their products comply with both Edition 3.1 and 3.2 of the standard. As version 3.2 includes a multitude of many small changes (78 in all), it would normally be considered wise to instigate a gap analysis for all existing products, to ensure that they will meet the new requirements set out in 3.2 edition. However, in reality, the vast majority of manufacturers are conducting testing according to the new standard edition, instead of conducting a gap analysis. This is because new test reports are required anyway for other international approvals and the effort involved is usually comparable.
