Tier I Market Requirements
Tier I markets generally consist of North America and Europe. For laboratory equipment manufacturer’s, fortunately the safety standard (EN/CAN/UL 61010-1) is harmonized between the U.S./Canada, and Europe. For these types of products, it makes sense to get safety certifications for both markets at the same time. But even though the standard requirements are similar, the certification schemes for each market are quite different. In Europe the CE compliance scheme is mandatory but based on the manufacturer’s self-declaration. The self-declaration process offers more flexibility than other certification schemes. This flexibility can come in handy in developing and executing a test plan where the manufacturer can have a say in the complexities of the process. In both Canada and the U.S. certification is mostly voluntary. For manufacturers selling B to C or through re-sellers, a mark from a Nationally Recognized Testing Laboratory (NRTL) is almost always mandated due to customer requirements. However, for manufacturers selling large or customized equipment B to B, there are generally less requirements on the certification type.
U.S. and Canada Certification Types
For products such as laboratory and control/measurement equipment, the complexity of the equipment in addition to the variability in configurations can make NRTL listings for North America cost prohibitive and a logistical nightmare. In this case, an alternative to an NRTL certification is a field evaluation or field label. Field label evaluations require less testing, evaluation, and documentation than NRTL listings, making the process simpler and more cost effective. However, field labels do require an evaluation of each product to be certified, and are typically performed at the final installation site. Once an inspection and report based on a representative sample are created, evaluations of additional configurations are generally quite painless. As a result, even with the additional step of evaluating each unit, the field evaluation process is likely to be much simpler and more cost effective than undergoing months of slogging through the NRTL process. This alternative to NRTL certification will require customers to understand the differences between NRTL marks and field labels (see Field Evaluation Services for a breakdown of differences). Educating the customer on the differences between the two certification types is important. We find that the distinction between these two can be confusing even to some in the compliance industry. That being said, a proper explanation of the differences along with the big picture benefits should suffice, and could pay big dividends.
CE + Field Label Route
To summarize, when harmonized standards exist, we recommend conducting evaluations for both European and North American requirements simultaneously. For laboratory and control/measurement equipment, we further recommend looking into a CE/Field Evaluation strategy for Tier I markets. This dual pronged strategy can be accomplished with a representative sample of the equipment and a test plan that addresses the complexities and variations in configurations. This strategy works best when you partner with an experienced test lab that can provide field labeling capabilities along with a consultative approach to the CE test plan. With the right test lab on your side, significant savings in time and resources are achievable with a CE/Field evaluation strategy to satisfy your Tier I compliance requirements.
For more information on G&M CE mark capabilities, see CE Mark Services
For more information on G&M Field Evaluations, see Field Evaluation Services
For questions on this article, go to Contact us or call (714) 628-1020