Tag Archives: risk management
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 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
2012 ICPHSO Meeting and Symposium Addresses Global Regulatory Issues
The 2012 International Consumer Product Health and Safety Organization (ICPHSO) Annual Meeting and Training Symposium in Orlando moved into Workshop Day yesterday. Some of the topics that were addressed: Global regulatory outlook Comparing Canadian and U.S. Consumer Product Safety Law EU Directives related to toys Effective recalls Risk management Global product safety strategies Hazardous substance regulations... Read More
60601-1 Third Edition Overview Covers Key Changes from Second Edition
This Compliance Today blog post is derived from the second half of a MET Labs-hosted 60601-1 3rd Edition Overview webinar. Find the transcription of the first half of the webinar here, or the full recorded webinar here. Following are the key changes from the 2nd to 3rd edition of 60601-1 for electro-medical device product safety... Read More
Medical Product Safety Training Yields Insight on IEC 60601-1 3rd Edition
MET Laboratories’ product safety engineers undergo regular training to stay up-to-date with changing standards and regulatory requirements. When possible, we will share highlights of these sessions with customers. Following are some of the key points of a recent training session on IEC 60601-1 3rd edition: It is an entirely new standard and does not match... Read More
IEC 60601-1 3rd Edition Challenges Medical Products Industry
Rarely has a standard change elicited as much confusion – and anguish – as the transition to the third edition of 60601-1. Much of the confusion surrounds the varying rates of adoption of the new edition in different countries and regions. Here is a basic primer: IECEE CB Scheme – Issued in 2005, IEC 60601-1... Read More
