Tag Archives: medical device testing

FAQ: Wireless Coexistence Testing for Medical Devices

FAQ: Wireless Coexistence Testing for Medical Devices What wireless technology that is used in the medical device can E&E test?  Eurofins E &E developed a methodology to evaluate medical devices, depending on their wireless functions (Wi-Fi, Bluetooth, ZigBee), operating up to 7.2GHz ISM bands for the following wireless technology systems: IEEE 802.11a/b/g/n/j/p Long-Term Evolution (LTE,... Read More

FAQ: Risk Management for IEC 60601-1

FAQ: Risk Management for IEC 60601-1 What you need to know about Risk Management for medical devices What is Risk Management in 60601? Risk management is a series of risk evaluations performed by the manufacturer, based on ISO 14971, which are undertaken and documented throughout the design, production and post-production process of medical equipment. The... Read More

FDA Issues Guidance on EMC of Electrically-Powered Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered products for premarket submissions. Typically, the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of... Read More

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment

IEC 60601-1 Third Edition Amendment 1 (Ed. 3.1) What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding... Read More

FDA Issues Guidance for Integration of RF Wireless Technology in Medical Devices

Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical devices.  The guidance is recommended, but not mandatory. FDA said its recommendations cover devices that are implanted or worn on the body, and... Read More