Author Archives: Keith Cooper

IEC 60601-1-9 Environmentally Conscious Design – What is it?

Posted on August 14, 2024 by Keith Cooper

What exactly is the environmentally conscious design file?  You need documentation/policies that show how you are addressing the requirements of that standard.  You really should use the standard as guidance (IEC 60601-1-9).  Here is some good information on what this … Continue reading →

Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745 | Comments Off on IEC 60601-1-9 Environmentally Conscious Design – What is it?

Reese’s Law – What You Need To Know

Posted on July 3, 2024 by Keith Cooper

Reese’s Law was signed by President Biden on August 16, 2022 and as of March 19, 2024 all products that incorporate button batteries or coin cell batteries must comply with UL certification 4200A as the safety standard for performance and … Continue reading →

Posted in Listing, Product Testing, UL 4200A | Comments Off on Reese’s Law – What You Need To Know

FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data

Posted on February 29, 2024 by Keith Cooper

The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices that they should always be vigilant in verifying the accuracy of third party testing data that they are using for … Continue reading →

Posted in FCC, FDA, Product Testing | Comments Off on FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data

I Want to Send a Flatscreen Monitor to the EU, What Now?

Posted on January 30, 2024 by Keith Cooper

Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations and Directives that may apply to your given product.  Without the help of a trusted testing partner (seriously, contact us … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, General Product Safety Regulation (EU) 2023/988, GPSR, GPSR (EU)2023/988, Low Voltage Directive 2014/35/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, UL 62368-1 | Comments Off on I Want to Send a Flatscreen Monitor to the EU, What Now?

Pacemakers and Electric Cars

Posted on April 27, 2023 by Keith Cooper

Over the past decade, we have seen an explosion of popularity with various green technologies, and at the forefront of that are electric vehicles and the charging stations that keep them going.  A new study questioned whether individuals who wear … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, FCC, FDA, Radio Equipment Directive 2014/53/EU | Comments Off on Pacemakers and Electric Cars

ESD and Electric Vehicles (EVs) – New Challenges

Posted on January 5, 2023 by Keith Cooper

Electric vehicle (EV) technology continues to evolve, grow, and become more commonplace. Changes and an increase in popularity will continue, especially with the insertion of ethernet technology for data communication in those systems. ESD protection is extremely important; especially in … Continue reading →

Posted in CE marking, EMC Directive 2014/30/EU, EMC Testing, EN 60601-1, FCC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Product Testing, Radio Equipment Directive 2014/53/EU | Comments Off on ESD and Electric Vehicles (EVs) – New Challenges

WPT for EVs and the Effect on AM Radio Broadcasts

Posted on December 19, 2022 by Keith Cooper

As more and more electric vehicles (EVs) continue to be utilized both by the public and by government agencies to help reduce our carbon footprint and reduce greenhouse emissions, the infrastructure used to power these vehicles continues to grow. An … Continue reading →

Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EVs, FCC | Comments Off on WPT for EVs and the Effect on AM Radio Broadcasts

Enforcement of the UKCA Mark is Postponed

Posted on November 21, 2022 by Keith Cooper

On November 14, 2022 the UK announced that use of the UKCA Mark (for Great Britain) is to be postponed an additional two years until December 31, 2024.  Previously, mandatory use of the mark and scheme was supposed to be … Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, UKCA | Comments Off on Enforcement of the UKCA Mark is Postponed

Changes to the Korean EMC standard KS C 9814-1

Posted on November 9, 2022 by Keith Cooper

On May 31, 2022, a new version of KS C 9814-1 was issued and is applicable to products that fall in the category of household appliances, electric tools, and other similar apparatus.  Examples of equipment that fall in this category … Continue reading →

Posted in EMC Testing, International Testing | Tagged | Comments Off on Changes to the Korean EMC standard KS C 9814-1

What Now?

Posted on February 3, 2022 by Keith Cooper

A comprehensive guide into the listing standards that are required after testing to compliance marks. Continue reading →

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, FCC, FDA, Field Label, GPSR, GPSR (EU)2023/988, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, SPE-1000, UKCA, US Field Label | Comments Off on What Now?