Weekly Whitepaper

Understanding the FDA-ASCA Program

August 11, 2021

What is FDA-ASCA? ASCA is an FDA acronym meaning “Accreditation Scheme for Conformity Assessment”. The FDA has developed a system for accreditation of experienced medical testing laboratories to perform conformity assessment of medical devices…

The Element of Electrical Medical Product Compliance

May 11, 2020

Required Elements for Certification In order to certify your electrical medical product, the product must comply with the following standards. In addition, compliance reports for each standard are needed in preparation for, and as…

60601-1: MOPP vs. MOOP

July 30, 2019

Patient & Operator Electric Shock Protection…

62368 – Hazard-Based Safety Engineering

June 19, 2019

Pain, Injury, & Ignition of Combustible Materials…

CE Readiness Test

June 10, 2019

Are You Really Ready for CE?…

62368: 2nd or 3rd Edition?

June 3, 2019

60950 & 60065 are being replaced!…

Different Types of Product Users & A New User Type

May 15, 2019

UL-CSA-EN-IEC Standards; 62368 Introduces New User Type…

62368 & the Legacy Component Provision

May 1, 2019

60950 & 60065 are being replaced!…

Product Safety vs. EMC – Which Testing First?

April 16, 2019

UL-CSA-EN-IEC-FCC Standards…

62368 – A Giant Change is Coming Soon

March 20, 2019

60950 & 60065 are being replaced!…

62368 – A Giant Change is Coming Soon

March 15, 2019

60950 & 60065 are being replaced!…

Is Air the Perfect Electrical Insulation?

March 6, 2019

UL – CSA – EN – IEC Risk of Shock Protection…

When is It Considered a Medical Product?

February 26, 2019

Medical vs Lab Equipment vs Wellness – 60601 vs 61010 vs Other Standards…

Intrinsically Safe Devices & Control Drawings

February 20, 2019

I.S. Circuits and Devices…

Understanding Electrical Insulation Types

February 13, 2019

UL – CSA – EN – IEC Risk of Shock Protection…

Selecting Plastics for UL Certified Products

February 5, 2019

It’s More Than Just Identifying the Flame Rating…

Purge & Pressurization of Electrical Enclosures

January 30, 2019

Class, Division, Zone Compliance…

Evolution of a Harmonized Product Safety Standard

January 16, 2019

From IEC to EN, CSA, & UL…

Ergonomics & 61010-1

January 10, 2019

UL61010-1; CSA61010-1; EN61010-1; IEC61010-1 Laboratory, Test, Measurement & Control Equipment…

UL Label System Requirements

December 17, 2018

Avoid the common mistakes…

General Purpose Equipment in Classified Areas

November 26, 2018

Class/Division rated hazardous classified areas…

CE Documentation

November 12, 2018

In the process of preparing for and verifying CE compliance for a product, there is a considerable amount of documentation that must be generated and maintained. Some of the documentation is product specific and…

US – UL Product Certification Options

November 5, 2018

Field Labeling – Batch Certification – Listing…

Hazardous Location Protection Methods – Class I

October 15, 2018

If your product must be marked for use in a Class I (Gas) Hazardous Location, it must comply with one or more protection methods suitable for Class I environments. Not all protection methods are…

Does Your CE Mark Need a 4 Digit #?

October 8, 2018

General: A 4 digit number next to or underneath a CE mark is a “Notified Body” (NB) number. This number is traceable to the Notified Body that approved the CE mark on the product….

Understanding IPX9 & IPX9K Testing

October 1, 2018

Understanding IPX9 & IPX9K Testing Ingress Protection Testing…

What is a Classified Area & Why is it Hazardous?

September 17, 2018

UL, CSA, CE-ATEX, IECEx…

Is CE Required to Exhibit Products in Europe?

September 3, 2018

In general, non-CE marked products may be shown at trade fairs, exhibitions and demonstrations. However, the language that supports this statement varies by Directive. In all cases, the manufacturer has an obligation to inform…

CAUTION with Zone 1 Ratings & the United States

August 27, 2018

ATEX Zone 1 ≠ Division 1…

Pass/Fail Criteria for IP Wet Testing

August 20, 2018

Ingress Protection Testing…

CE Pressure Equipment Directive Basics

August 14, 2018

Directive 2014/68/EC…

Understanding “Fixing of Wiring”

August 6, 2018

UL – CSA – EN – IEC…

Plastics Testing – Flame Tests & Flame Ratings

July 30, 2018

UL – CSA – EN – IEC…

Is Your IP Rating Repeatable & Reliable?

July 23, 2018

Ingress Protection Testing…

UL vs. CE-ATEX

July 16, 2018

What’s the difference?…

UL vs. CE

July 9, 2018

What’s the difference?…

Basic Requirements for CE of Construction Works

June 25, 2018

Construction Products Regulation EU No. 305/2011…

Do You Need a Risk Assessment for 61010-1?

June 18, 2018

UL61010-1; CSA61010-1; EN61010-1; IEC61010-1 Laboratory, Test, Measurement & Control Equipment…

What is a Risk Assessment & Do You Need One?

June 11, 2018

UL, CSA, EN, IEC, ISO Standards…

What is a European Technical Assessment?

May 28, 2018

Construction Products Regulation EU No. 305/2011…

Brexit Creates CE Disaster for the UK

May 21, 2018

The UK is simply not prepared!…

Understanding the CE Construction Products Regulation

May 14, 2018

Regulation EU No. 305/2011…

CE Essential Health & Safety Regulations (EHSR’s)

May 7, 2018

Directive 2006/42/EC…

CE Machinery Directive – Annex IV Products

April 30, 2018

Directive 2006/42/EC…

What is a CE Mark?

April 23, 2018

The CE mark on a product indicates that the product meets European Union (EU) compliance requirements. Most products are required to bear the CE Mark to be sold in the EU. This includes medical…