Medical
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
IEC 60601-1-2 4th Edition Medical EMC Webinar
In the 60601-1-2 4th Edition webinar, you will learn about changes coming with the 4th edition of the IEC 60601-1-2 standard. Topics include technical requirements, updates coming with the 4th edition of 60601-1-2, steps the manufacturer must perform to fulfill risk management requirements, new methods of risk analysis and immunity requirements to mitigate interference and... 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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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
Top 7 Questions about IEC 60601-1-2 4th Edition for EMC Testing of Medical Devices
This Compliance Today post is a follow up to last week’s post on IEC 60601-1 Edition 3.1. Are there safety benefits to the 3rd edition of IEC 60601-1-2 compared to the 2nd? The test levels required by both the 2nd and 3rd editions of IEC 60601-1-2 are the same. The main change was in clause... 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 Adds 4th edition of IEC 60601-1-2 to EMC Consensus Standards List
In July 2014, the FDA recognized the 4th edition of IEC 60601-1-2 as a standard that can be used to show EMC compliance for medical electrical devices and systems. The complete standard is recognized with the following exception: In Subclause 8.9, Table 8 on Page 39: The citation of Note b) under “Conducted disturbances induced... Read More
IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
The 3rd edition of IEC 60601, issued in 2005, is in various states of adoption by regulatory bodies around the world. IEC 60601-1 is the harmonized standard for medical electrical equipment recognized by public health authorities in most countries. Unlike 2nd edition, the 3rd edition requires a risk management file and process conforming to ISO... Read More
OSHA Close to Authorizing NRTL Certification to ANSI/AAMI ES60601-1 for Medical Equipment
After a long wait, medical electrical equipment manufacturers are looking forward to the Occupational Safety & Health Administration’s (OSHA) expected near-term recognition of one or more labs – including MET Labs – for product safety certifying medical devices to ANSI/AAMI ES60601-1:2005/(R)2012 under the U.S. Nationally Recognized Testing Laboratory (NRTL) Program. In March 2014, OSHA announced... Read More
IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements. Dates For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period... 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
