Tag Archives: essential performance
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
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
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
