The revision mandates compliance of new products by April 2017 in the USA and all products by August 2017 in the European Union. In the USA, existing products will need to comply if changes are made. Moreover, the Food and Drug Administration already accepts the fourth edition.
The new revision imposes significantly higher EMC test levels; for example, the ESD test levels are increased to 15KV air and 8KV contact, almost double the current specifications. In addition, there is a new wireless proximity test that increases the radiated immunity test levels to 28V/m at some frequencies, a significant change from the existing requirements. Therefore, manufacturers are advised to review the design of their products now to determine if any changes will be required to ensure timely compliance. Advance planning is critical for compliance, especially if a manufacturer has multiple products, all of which will eventually need to be re-tested to the new requirements.
The fourth edition changes the basic EMC compliance philosophy to define tests and limits according to risk and intended use instead of a device type. Tests are defined based on where the equipment will be used – either in a healthcare facility, at home (which includes almost everything except the healthcare environment) or in a special environment such as military, heavy industrial, or medical treatment area with high-powered medical equipment.
Among the major technical changes is the requirement that risk management process include EMC risks.
Additionally, the revision recognizes that RF wireless communications equipment can no longer be prohibited from most patient environments because it is often essential to the healthcare delivery. It acknowledges that for special environments, immunity test levels higher or lower than those specified for the professional healthcare and home environments might be appropriate.
TÜV Rheinland has a long history of providing EMC testing services to medical device manufacturers, and its test reports are accepted throughout the world. With more than 140 years of experience providing professional testing services, the organization is the winner of Frost & Sullivan’s 2014 European Customer Value Enhancement Award in EMC Testing (with a special emphasis on testing expertise of wireless medical devices).
For more information, visit www.tuv.com/us.
