Iec 60601 labeling requirements how to#

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. There are also obligations to cover electromagnetic disturbance risk management, and guidance to identify the criteria for immunity pass/fail.

Iec 60601 labeling requirements how to#

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. Exactly what is to be monitored during testing will need to be outlined in a test plan. The latest edition also requires clear pass/fail criteria prior to testing. There is a comprehensive table explaining the immunity requirements in tables 4 to 9 of the standard. This requirement is not all encompassing, however, as manufacturers need to take other sources of potential interference into account. It is crucial that equipment manufacturers test their products with a printer, when used, to ensure the unit passes as a whole. The requirement for ESD (electrostatic discharge) resistance has changed from 8kV to 15kV, which includes the printer when it is connected to any equipment. 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. There is also an increased risk of EM emissions that can impact electronic medical devices. 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. It is the manufacturerвЂ™s responsibility to ensure compliance. Equipment will need to meet this new standard in order to be sold in the locations in which it applies. 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. It also dictates the standards required in the electromagnetic disturbances emitted by such equipment. This standard sets out the basic and essential performance requirements for medical equipment and systems when in the presence of electromagnetic disturbances. With it, there are a number of changes that are likely to have an impact on a large proportion of businesses within the sector. One such standard is IEC 6, and on 31 December 2018, the fourth edition will be released. 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.