Blog

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

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

Partner Corner: What’s New at SIQ

Partner Corner: What’s New at SIQ New 9000 square meter facility and MET partnership provide more effective access to North American Certifications For more than 50 years, SIQ has provided comprehensive services for product testing & certification, management systems assessment, metrology, and training. Located in central Europe – Slovenia, SIQ maintains its international recognition and... Read More

FAQs: IEC 62368-1 replacing IEC 60950-1 & IEC 60065. What you Should Know

What you should know about IEC 62368-1 HBSE FAQ IEC 62368-1 HBSE replacing IEC 60950-1 and IEC 60065: Frequently asked questions. Multimedia devices are rapidly converging and rapidly adopting new technology that enables better communication and performance. As a result, The line separating Audio/Visual equipment from IT products continues to be blurred. As new devices... Read More

How rugged are your products? Using MIL-STD-810 to improve the durability and ruggedness of commercial products.

How rugged are your products? Using MIL-STD-810 to improve the durability and ruggedness of commercial products. Although it was developed by the United States military, MIL-STD-810 is a test methodology that is used by many manufacturers now, regardless of whether they plan to sell to the U.S. Department of Defense. MIL-STD-810G allows for tailoring an... 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

Hazardous Locations Guide: Certification & Markings

Hazardous Locations Guide: North American and IECEx/ATEX Certification & Markings The world of hazardous locations can be challenging to navigate as combustible dusts, flammable gases, mists or vapors can all contribute to potentially explosive atmospheres in the workplace. All equipment manufactured for use in explosive atmospheres must be suitably marked and there are many requirements... Read More

R&TTE to RED Transition Period for Radio Equipment Nearing an End

The European Parliament and Council Directive on Radio and Telecommunication Terminal Equipment (1999/5/EC) was revised in 2014 to become the Radio Equipment Directive 2014/53/EU. The R&TTE Directive covers all equipment that uses the radio frequency spectrum, with a few exceptions. It also covers all terminal equipment attached to public telecommunication networks. The main objective of... Read More