Medical device standards are changing and that means many devices have become obsolete. If you develop or sell medical devices, you need to be aware of these changes. They could make a massive impact on the future of your business.
The IEC 60601-1-2 standard covers general requirements for basic safety and essential performance of medical electrical equipment and systems. It has been revised to the point where devices previously certified to the standard no longer comply with the latest revision.
And there are still more changes ahead.
Short of driving these devices to an early obsolescence, these updates could complicate quality systems while extending development schedules and time to market.
DornerWorks is partnering with EMC design experts at SILENT Solutions LLC to help companies maintain standard compliance and avoid massive losses.
First, let’s talk about what the changes entail.
The third edition of IEC 60601-1 was published in 2005 and amended in 2012. The more recent second amendment focuses on mitigating concerns raised by stakeholders within the medical device industry, correcting technical errors, inconsistencies, and outdated references to other standards.
Updates to these areas began in 2016 and were rolled out in June 2020. The 4th edition of the IEC 60601-1-2 will bring further changes sometime in 2027 or later. Until then, the second amendment will be the benchmark medical device hardware must meet, else risk being pulled from the market.
Key changes to the standard involve operator and patient protection, electromagnetic disturbances, and alarms.
IEC 60601-1-2 addresses requirements for any class of medical electrical equipment that patients use or that is used near them by medical staff or equipment operators. These requirements serve to ensure people are protected from dangers like electrocution.
The second amendment updates to the standard tighten up descriptions of allowable touch currents and protective requirements, including:
The updates also redefine requirements for pressurized medical equipment and support systems, whether that pressure be pneumatic, hydraulic, or tensile like the chassis of a hospital bed.
The process of testing a product for a potential to cause any of the dangers listed in these updates is defined in another standard, ISO 14971:2019, Medical devices — Application of risk management to medical devices, though IEC 60601 also describes ways to manage these risks.
Electronic devices are found nearly anywhere you find people. Since many of those devices are able to send and receive data through some mode of wireless communication, they may also have unintended effects on other signals. IEC 60601-1-2 focuses on that risk, and Annex A General Guidance and Rationale provides further help in preparing a risk management approach to electromagnetic disturbances.
Updates to IEC 60601-1-8 affect the way alarm systems in medical electrical products and systems must be developed and tested. These alarm systems include:
Changes to the standard also affect IP classification.
Products that do not meet the updated medical device hardware standard will be pulled from operation. This can negatively impact your business, but it doesn’t have to.
If you have any concerns that your products may not meet the updated requirements in IEC 60602-1-2, we can help you develop a plan to put regulatory conformance worries aside and focus on your product design.
Schedule a meeting with us today. We can help you ensure your products meet the necessary standards and protect your business from unnecessary losses.