Global requirements

Requirements in the United States

For a detailed explanation of the development of United States requirements and standards for programmable electronic systems, reference the following article, Programmable electronic systems conformity assessment: U.S. experiences to date and the way ahead, written by David A. Dini, a senior research engineer at UL.

FDA and OSHA mandatory United States requirements

In the United States, mandatory governing regulations are in the Code of Federal Regulations (CFR) and are regulated by the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA). Specific sections of 21 CFR apply to medical devices and automated production processes and laboratories. The FDA also has guidance memoranda that address medical devices, automated production, and data management and analysis in support of clinical research.

For more information see UL's Medical section or the FDA's recognized consensus standards site.

OSHA covers the use of computers including software as related to workplace safety. For instance, 29 CFR 1910.217 requires third-party validation for presence-sensing devices. OSHA requires that design, installation and changes be addressed to meet certification requirements.

Requirements in Europe

In the European Union (EU), programmable systems are covered in the New Approach Directives which address gas, machinery and medical devices. EU member states are currently enforcing international software safety requirements. As a manufacturer contemplating entering international markets, consider getting your software certified to international standards. Redesigning a software component or system originally designed to comply with only one country's requirements can be more costly and time-consuming than obtaining third-party certification.

One method of complying with EU safety requirements is to evaluate the product using specified Directives. The process can be expedited by having a globally-recognized third-party certifier like UL help with the evaluation process. Once the product complies with all applicable requirements, a CE Marking can be applied that is recognized throughout the EU. This can help reduce the cost of doing business on a country-by-country basis.