Tag Archives: Medical
Electrical/Electronic Regulatory Requirements for Top 5 Middle East Economies
Driven by vast petroleum resources, many parts of the Middle East are growing rapidly. Following are the region’s biggest economies (listed largest to smallest), and electrical/electronic regulatory compliance issues for each. Turkey Boasting the largest economy in the Middle East, Turkey is being considered for European Union membership and the EU CE Mark is accepted... 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
Health Canada Provides Guidance on IEC 60601-1 3rd Edition Transition
For Medical Electrical Equipment product safety compliance in Canada, Health Canada currently recognizes both the second edition of IEC 60601-1, published in 1988, and the third edition, published in 2005. In October, 2008, Health Canada published a notice indicating that until June 1, 2012, conformity to the second edition of IEC 60601-1 and its related... 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
60601-1 Third Edition Overview Outlines Adoption in U.S., Canada & EU
Last week, MET Labs hosted a 60601-1 Third Edition Overview webinar. The webinar was very popular, so we are following up with a transcription of many of the key points. About half of the presentation was devoted to regional acceptance. United States In the U.S., the current standard is UL 60601-1 First Edition, with revisions... 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
Safety Certification to UL/IEC 61010-1 Evolves
Product safety certification for healthcare & other laboratory equipment continues to evolve. Thirteen months ago, on January 1, 2010, all new products and alternate constructions of listed or recognized products were required to be evaluated to UL 61010-1 2nd Edition. The Second Edition combines UL 61010A-1 for laboratory equipment, UL 61010B-1 for test and measurement... Read More
