Designing for Compliance” is critical to getting your product certified on the first try. Designing for Compliance requires owning, knowing, and applying the standard(s) while designing your product. However, in order to successfully read and understand the standard, you have to know the intent of the requirements. Our “Designing for Compliance” series of whitepapers will educate you on “The 6 Hazards of Product Safety”. The intent of the requirements in all UL/CSA/EN/IEC safety standards is to protect the user from the “6 Hazards of Product Safety”. This whitepaper covers Hazard #5 – Risk of Radiation.
Risk of Radiation Definition: A “Risk of Radiation” exists when a product generates radiation that could present a health hazard to the user - Ionizing, Non-ionizing, Optical, RF, Microwave, and Acoustic radiation commonly found with X-ray, VLF, ELF, UV, IR, laser, magnetic, sonic, and ultrasonic technology. The objective is to protect the user from excessive radiation. Because radiation is usually invisible, many people are unaware when they are using or in the presence of a radiation emitting device. Even some product manufacturers are surprised to learn that their product emits radiation that must be limited and contained.
Products Involving a Risk of Radiation: Products that emit radiation are all around us. They include many medical products such as X-ray equipment and ultrasound devices. They also include several popular consumer products such as the microwave oven, suntan beds, laser tag guns, and the laser pointer. Many commercial products also function using technology that emits radiation, such as bar code scanners and fiber-optic cables.
Protecting the User from Radiation: In general, you want to avoid subjecting the user to radiation unless absolutely necessary for product functionality. In which case, you must limit the exposure level to as low as possible. Product specific requirements indicate exposure limits, user warning markings, user instruction contents, and in some cases, the need for personal protective equipment.
Product Radiation Requirements: In the U.S., products that emit radiation are controlled by the CDRH (the Center for Devices & Radiological Health, a division of the FDA). The product compliance requirements are defined in the Code of Federal Regulations Title 21 (21 CFR).
In the European Union, the applicable radiation hazard protection requirements for most commercial and consumer products are contained in the product specific standards identified under the applicable CE-Directives. Canada is similar with many CSA standards harmonized with EN/IEC standards. For other International countries, the product specific IEC standards should be consulted. Note that for medical products, additional government regulations may apply depending on the country of use.
Risk of Radiation – Summary: If you make a product that emits radiation, you must limit exposure as much as possible without defeating the purpose of the product – be sure to identify the radiation limits for your product for the countries of distribution.
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