The Association of Electrical Equipment and Medical Imaging Manufacturers
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FAQs: Product Certification and Testing


This document answers frequently asked questions regarding international trade of electrical products. For further information or to submit a question, please contact NEMA’s manager of conformity assessment programs, Joel Solis, via e-mail or fax (703) 842-3367.

Questions

Answers

What does the term “conformity assessment” mean?

The ISO/IEC Guide 2:1996 definition of conformity assessment is “any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.” Conformity assessment is a broad term covering the activities undertaken to verify that products are produced or services are provided that meet a Standard and are therefore found to be satisfactory for use. The activities that are generally considered to fall under conformity assessment are testing, surveillance, inspection, auditing, certification, registration, and accreditation.

There are various standards that apply to each of these activities. For product certification, they include:

  • ANSI/ASTM E 1906-99, Standard Guide for General Requirements for Bodies Operating Product Certification Systems, or ISO/IEC Guide 65:1996, General requirements for bodies operating product certification systems
  • ANSI/ASTM 1904-99, Guide for General Criteria for a Supplier’s Declaration of Conformity, or ISO/IEC Guide 22:1996, General criteria for Supplier’s Declaration of Conformity
  • Various design and/or safety standards for individual products

For an overview of the entire U.S. conformity assessment process, refer to NIST IR 6014, The ABC’s of the U.S. Conformity Assessment System (April 1997).

Is the CE Mark sufficient justification for an electrical inspector to accept a product for installation according to the National Electrical Code©?

The existence of the CE Mark has no bearing on whether or not the product complies with the appropriate standards in North America. The mark only indicates that the product meets the essential requirements mandatory in the member states of the European Union and allows free movement in the European community.

The product must meet the appropriate North American Standards to carry the listing mark (UL, CSA, ETL, ANCE, etc.), which indicates compliance with the appropriate product standards for installation in North America. Some products that meet the appropriate North American standards may also be certified to carry the CE Mark. However, the CE Mark alone is not sufficient justification to determine compatibility with the electrical installation code being enforced.

What is the National Conformity Assessment Strategy?

A few years ago, considerable work was done by the ANSI Board Committee on Conformity Assessment (BCCA) in conjunction with members from industry, government and trade associations to develop a National Standards Strategy (NSS). The goal of the NSS is to increase U.S. participation in the development of international standards, streamline the process of standards development using productivity enhancements such as teleconferencing, electronic transmission of documents for review and comment, etc., and to educate the U.S. manufacturers, specifiers, regulators and other interested parties regarding the benefits of international standards. The NSS is available on the ANSI website.

When the NSS was developed, it was suggested that there should be a companion National Conformity Assessment Strategy (NCAS). Due to significant concerns expressed over the attempt to initiate development of the strategy, it met with considerable opposition. Due to the wide range of activities comprising conformity assessment, and the variety of methods employed within industry sectors to assess conformity of products, the goal of a NCAS was questioned by industry, government, consumers and trade organizations. ANSI conducted a workshop in September of 2001 on the subject of the need to develop a strategy document and it was decided instead to develop a document to describe the U.S. conformity assessment system, hopefully as a tool to aid in gaining better understanding and acceptance of U.S. conformity assessment practices in the domestic and global markets. As the document was nearing completion, it was decided to limit its scope to a set of U.S. principles of conformity assessment as a way to clarify U.S. compliance with the general principles found in the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement. The National Conformity Assessment Principles for the United States was approved by the ANSI Board of Directors on September 24, 2002 and is available on the ANSI website.

What is the IECEE CB Scheme?

The CB Scheme, also known as the Scheme of the International Electrotechnical Commission System for Conformity Testing and Certification of Electrical Equipment (IECEE), offers manufacturers an opportunity to increase global marketability. The scheme facilitates the international exchange and acceptance of product-safety test results among participating Certification Bodies for national approval or certification in one or more countries, normally without the need for additional testing. This is a universal goal among suppliers, consumers, and interested parties stated as “one standard, one test, accepted everywhere.”

What is the IECEx Scheme?

The objective of the IECEx Scheme is to facilitate international trade in electrical equipment intended for use in explosive atmospheres (referred to as Ex equipment).

Can I get my product certified at NEMA?

NEMA does not certify products. NEMA is an electrical industry trade association focusing on the development of product standards, government affairs and market economics.

NIST Special Publication 903, Directory of U.S. Private Sector Product Certification Programs (July 1996), and NIST Special Publication 739, Directory of Federal Government Certification and Related Programs (July 1999) are available on the NIST website. These documents list hundreds of different private sector and government organizations that recognize testing and certification bodies. Lists of standards used and products certified by the testing bodies recognized by the organizations are listed. The organizations can be contacted to obtain the names and locations of the testing bodies that have demonstrated the ability to test products to published standards.

In addition, ASTM International (formerly the American Society for Testing and Materials) publishes a Directory of Testing Laboratories. It contains over 1000 testing laboratories , some of which perform testing in the electrical products field. It is available for purchase under Product Code LAB01 on the ASTM International website.

NEMA Engineering Bulletin No. 86 says that conformity assessment systems should be pursued in a manner that reflects the principles of the Technical Barriers to Trade Agreement (TBT) of the World Trade Organization (WTO). What are those principles?

The entire text of the WTO Agreement, including the TBT Agreement, can be downloaded from the WTO website. The TBT Agreement is intended to “...ensure that in respect of technical regulations, products imported from the territory of any Member shall be accorded treatment no less favorable than that accorded to like products of national origin and to like products originating in any other country.”

In simple terms, the agreement intends to ensure that technical regulations do not have the effect of creating unnecessary obstacles to international trade. Acceptable objectives upon which to base exceptions are national security requirements, prevention of deceptive practices, protection of human health or safety, animal or plant life or health, or the environment.

To achieve these aims, the adoption of international standards or harmonization of national standards is encouraged along with active participation in the development of such standards. Members are required to notify other countries whenever a technical standard does not exist or when there are differences between a country’s standard(s) and those of other member countries. They are also obligated to provide notice to other Member countries when new regulations or revisions to existing regulations are being proposed and to be receptive to comments.

The guiding principle is to establish a situation where producers can gain access to markets in foreign countries under the same treatment as producers in those countries. For more information about tariffs, visit NEMA’s international trade center.

What is NEMA’s position on testing and labeling?

NEMA’s position is that testing should be under sponsorship and procedures which meet the requirements of ANSI/ASTM E 1906-99, Standard Guide for General Requirements for Bodies Operating Product Certification Systems, or ANSI/ASTM E 1904-99, Guide for General Criteria for a Supplier’s Declaration of Conformity.

Labeling is intended to inform the buyer, or the authority having jurisdiction, of the product’s tested conformance with the standards, and may be used to alert and inform with respect to particular hazards, precautions, or limitations related to the product. NEMA believes that labeling should be under the sponsorship and procedures that meet the requirements of the previously referenced American National Standards.

What does laboratory accreditation involve?

Accreditation is a term used in officially establishing the capability of a laboratory to conduct evaluations of products or services. There are two recognized American National Standards (ANS) and two international standards that apply to the accreditation process.

American National Standards:

ASTM E548-94, Standard Guide for General Criteria Used for Evaluating Laboratory Competence, includes characteristics to be employed in assessing a laboratory’s technical and quality management systems. ASTM E994-95, Standard Guide for Laboratory Accreditation Systems, provides requirements for the accreditation body to carry out as part of the accreditation process. Of importance in this process is the stipulation that there be a single test standard for each product. It is essential to the integrity of the product certification process that there be a single standard and uniformity in the interpretation of test results for each product. This fundamental requirement is embodied in E994.

International Standards:

ISO/IEC 17025:2000, General requirements for the competence of testing and calibration laboratories and ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems – general requirements for operation and recognition.

NEMA supports, where market conditions require, the accreditation of laboratories to test the conformance of electrical products to standards. NEMA supports accreditation systems in the private sector where unique circumstances justify such a procedure.

What are the National Conformity Assessment Principles for the United States?

The National Conformity Assessment Principles for the United States is an ANSI document that provides a set of U.S. principles of conformity assessment as a way to clarify U.S. compliance with the general principles found in the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Agreement. The document was approved by the ANSI Board of Directors on September 24, 2002 and is available on the ANSI website.