Medical equipment compliance regulations - how will changes affect you?
The medical equipment industry is subject to such a vast amount of standards and regulations that it can be difficult to keep track of all of the necessary legal requirements.
One such standard is IEC 60601-1-2, and on 31 December 2018, the fourth edition will be released. With it, there are a number of changes that are likely to have an impact on a large proportion of businesses within the sector.
Who does it apply to?
This standard sets out the basic and essential performance requirements for medical equipment and systems when in the presence of electromagnetic disturbances. It also dictates the standards required in the electromagnetic disturbances emitted by such equipment.
These regulations will apply to all medical electrical devices, as well as printers when offered with the equipment, and will apply across many nations worldwide. Equipment will need to meet this new standard in order to be sold in the locations in which it applies. It is the manufacturer’s responsibility to ensure compliance.
Why has the standard changed?
It has been identified that there is reduced control of Electromagnetic (EM) disturbances in locations outside of the traditional hospital setting, such as in the home or special environments. There is also an increased risk of EM emissions that can impact electronic medical devices. The fourth edition addresses the use of equipment in these environments, and aligns the standard more closely with safety standard IEC60601-1 and its emphasis on risk management.
What are the main areas of change?
The requirement for ESD (electrostatic discharge) resistance has changed from 8kV to 15kV, which includes the printer when it is connected to any equipment. It is crucial that equipment manufacturers test their products with a printer, when used, to ensure the unit passes as a whole.
This requirement is not all encompassing, however, as manufacturers need to take other sources of potential interference into account. There is a comprehensive table explaining the immunity requirements in tables 4 to 9 of the standard.
The latest edition also requires clear pass/fail criteria prior to testing. Exactly what is to be monitored during testing will need to be outlined in a test plan.
Risk management requirements are also included in the new edition, providing guidance for how to determine the immunity test levels within environments outside of traditional healthcare environments. There are also obligations to cover electromagnetic disturbance risk management, and guidance to identify the criteria for immunity pass/fail.
How much will this impact the industry?
The widespread impact to the industry is difficult to gauge at present, but we are aware that some companies are likely to need to undertake a substantial amount of equipment resign in order to comply.
How do I discover more?
The documentation is rather comprehensive, as standards such as these tend to be, but section 6 details the tests requirement. Pass/fail criteria and monitoring are outlined in section 8, and should be provided to the test laboratory together with detailed test plans.
Is there anything else on the compliance agenda for the future?
In the USA organisations are now requesting that products are labelled with a barcode or GTIN labelling, and the NHS is starting to ask for this on medical devices, too.
GTIN labels are one type of identifier label that incorporates static identifying codes such as manufacturer and name of product, together with dynamic codes to identify the date of manufacture and serial number, for instance.
There are certain requirements associated with this label – that it must withstand a set number of wipes with alcohol cleaner, for example. Our in-house design and engineering teams will be able to discuss the implications and potential solutions to help manufacturers in meeting these new requirements.