Medical Device Evaluations

SEL can support the preparation of a proper risk management file by performing a gap analysis with your team. We have been involved in some of the most complex medical systems over our decades in this space, along with many of the simpler varieties. While our practical "hands on" experience dates back to the old days of UL544, our experience in more recent standards and regulations includes:

  • IEC/UL60601-1 Third Edition including its two amendments;

  • IEC60601-1-x Collateral Standards for certain aspects of products, such as IEC/EN60601-1-2 for EMC; or IEC/EN60601-1-6 for Usability;

  • IEC60601-2-x Particular Standards for various types of products;

  • ISO 14971 for Risk Management Systems;

  • Medical Device Directive (MDD) 93/68/EEC;

  • Medical Devices Regulation (MDR) 2017/745

As IEC/UL60601-1 lays out -- even in its title -- there is BASIC SAFETY and ESSENTIAL PERFORMANCE. The latter is mentioned 141 times in the Standard and is often referenced as the pass/fail criteria for each particular test, but is ultimately defined by the manufacturer. SEL can help define this with our clients, and determine test protocols and pass/fail criteria with an understanding of your medical product.

 

The IEC/UL60601-1 standard has evolved the concept of an APPLIED PART over its history, with particularly large steps between the 2nd and 3rd editions, which actually has a more narrow definition meaning there are fewer APPLIED PARTS by today's definition. And the definition of medical equipment has been narrowed and more clearly defined in the standard of late.

 

SEL will often use the Test Reports such as that for IEC60601-1 as a means to capture what has been done to date, and what remains to be done, as the product is evolving into compliance, and to identify non-compliances earlier rather than later. We can conduct pre-testing on early designs to confirm compliance long before the end of the project.

 

Our lab accreditation allows for SEL to conduct testing to UL60601-1 in our lab and submit final test data to an NRTL, without requiring the equipment to be tested at their location. This allows for better control for particular or unusual test protocols, and direct participation from our clients for complex, evolving medical products.