Tag Archives: FDA
FAQ: FDA Laser Notice No. 50
FAQ: FDA Laser Notice No. 50 What you need to know about Laser Safety for United States and International markets What is FDA Laser Notice No. 50? Laser Notice No. 50 is an FDA guidance document that determines what components of IEC 60825 and IEC 60601-2-22 can be used to meet requirements found in 21CFR1040... 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The U.S. Food and Drug Administration (FDA) has released a draft guidance document containing a list of recommendations for medical device companies who want to claim electromagnetic compatibility (EMC) of electrically-powered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
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
Electromagnetic Compatibility Compliance Engineers Use These EMC Resources
In follow up to our post on product safety web links, here are the Internet resources we use to keep current with electromagnetic compatibility (EMC) regulations and industry happenings. What are we missing? Leave a comment with a link to it. STANDARDS & REGULATORY North America FCC OET Federal Communications Commission Office of Engineering and Technology... 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
