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July 2010

Regulatory Compliance Program for a Manufacturer’s Product Development Program and the Role of the Compliance Specialist

In the ever-changing global economy there is a growing number of product regulatory compliance requirement standards being imposed on manufacturers. Before marketing their products to domestic and international customers a manufacturer must deal with regulatory issues that apply to the development of their products. This results in the manufacturer having to have a regulatory compliance function within his company’s organizational structure that is staffed by competent well-trained personnel. This includes a Compliance Specialist who will need to stay abreast of the steadily changing regulatory compliance requirements, technology advances, and new areas of product regulations. The primary areas where product regulatory compliance requirements are applied are EMC, Product Safety, Environmental Protection, and Energy Conservation. All of these requirements have a direct impact on a product’s development program that includes its quality and reliability attributes.

The iNARTE Informer – July 2010

HEADQUARTERS NEWS We are back to full strength at the office. Our new FCC operations...

Testing for Immunity to EMP

The 21st century as we know it, truly reflects the age of technology. Every aspect of life today is encompassed by the use of some sort of microprocessor based electronics intended to simplify tasks, to improve processes, and improve efficiency. Electronics are used to communicate with loved ones, manage finances, fly aircraft, even save lives. As greater advances in technology are achieved, electronics are found controlling more important safety critical functions at an exponential rate. Although electronics have provided us with obvious benefits, the increasing reliability on electronics has elevated our vulnerability to the effects electromagnetic pulses.

EMC and Aerospace

Aerospace equipment and systems are required to meet electromagnetic compatibility requirements to ensure proper operation and minimize risk to space programs. A standard has been established for electromagnetic compatibility for space related equipment and systems, SMC Standard SMC-S-008. The purpose of the standard is to minimize the risk to space programs with respect to electromagnetic phenomena and compatibility. A series of specific tests have been identified to confirm compliance.

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Design and Selection of Shielding Gaskets for Medical Devices and the Effect of Cleaning Solutions on Material Performance

EMI shielding is a critical component of many electronics-based medical devices, which are in turn integral for life-saving procedures and ongoing patient health care. Medical devices are frequently used in the vicinity of other electronic instruments, resulting in an increased risk of electromagnetic interference (EMI). This risk can be mitigated through the use and care of EMI shielding gaskets. For more than a decade the FDA has also expressed concerns for public health and safety in regards to device EMI and the solutions for these concerns.

Necessity But Insufficiency of Interoperability Measures to Assure Smooth Operation of the Wireless Networks

Wireless alliances like Wi-Fi and ZigBee certify wireless devices for interoperability which to the end user provide a confidence level of smooth operation between these devices from different manufacturers. For instance this level of interoperability is necessary (but not sufficient) to ensure communications on WLAN Wi-Fi segments containing an Access Point (AP) and a number of wireless client cards. The same concept applies to ZigBee networks where interoperability gives a confidence level for ensuring operation of devices such as a light bulb and a switch, an RF4CE remote control and paired TV, DVD player or set top box, but also insufficient to assure seamless operation of the network over time and under variable environmental conditions especially in demand-response time critical scenarios.

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