Regulatory Compliance

As the global economy is growing there are a number of product regulatory compliance requirements and standards that are imposed on manufacturers. The primary areas where product regulatory compliance requirements are applied are Electromagnetic Compatibility (EMC) and Product Safety. These two areas of regulatory compliance and requirements have a direct impact on the product’s development that includes the quality and reliability of the products.

EMC

In the United States the Federal Communication Commissions (FCC) governs the regulatory compliance for EMC. FCC Part 15 of the Rules covers the requirements for unintentional (incidental) radiators as well as low powered un-licensed transmitters. Some common low powered un-licensed transmitters are Cell Phones, WiFi, Zigbee, ZWave and Bluetooth. More information about FCC Part 15 can be found here.

In Canada the Innovation, Science and Economic Development Canada (ISED) also known as Industry Canada (IC) is the certification body for all intentional and unintentional (incidental) radiators. ISED also covers the technical specifications, administrative requirements and other conditions relating to the marketing of intentional and unintentional radiators. More information about Industry Canada can be found here.

Almost all countries in the world will have some level of EMC requirements. Many countries around the world have harmonized their EMC standards. It is essential to keep EMC considerations in mind when developing a product for market. As well, it’s important to test against the appropriate EMC standards early in the development cycle to minimize any last minute design changes that can delay your time to market.

Product Safety

Product Safety testing is another key regulatory compliance area that must be considered in the design of your product. In the United States product safety for the work place is administrated by the Occupational Safety and Health Administration (OSHA). In accordance with OSHA Safety Standards, any product used in the workplace must be approved by a Nationally Recognized Testing Laboratory (NRTL). This is needed to ensure that products can be used safely in the workplace. The NRTL approval applies to those products that are used in the workplace that are subject to OSHA’s jurisdiction. This includes many private employers in the USA. This also includes most Federal Government places of employment. More information about the NRTL program can be found here.

The majority of countries around the world have specified some level of product safety requirements. Many European and other countries have common harmonized product safety standards. The US and Canada are similarly harmonized. As with EMC it’s important to test and evaluate your product to the appropriate product safety standard early in development to enhance your time to market.

European CE Mark

European CE testing is primarily EMC and Safety related, with the protection of the public and consumers being a primary concern. Harmonization with related national regulations is also a key objective in an effort to reduce regulatory barriers between European countries, and to facilitate the movement of goods between them.

To satisfy the CE Mark through CE testing, a manufacturer must cover EMC (2014/30/EU), Low Voltage (2014/35/EU), Radio Equipment (2014/53/EU) Directives where applicable. Each references applicable harmonized standards. More information about the CE Mark for Europe can be found here.

Other regulatory considerations are:

It is imperative that manufactures consider and comply with the regulatory requirements for their equipment before it is marketed or sold.

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