Secure facility designs often comingle ICS/ICD-705 and NSA 94-106 design requirements, creating project confusion with significant design and cost implications. This article focuses on bringing some clarity to the differences between ICS/ICD-705 design guidance and NSA 94-106 performance requirements. The related secure facility design and construction process is also reviewed.
ESD protection from epoxy-based floor coatings often falls short of applicable static control standards. A better understanding of the strengths and shortcomings of different epoxy materials is essential to minimize risks.
This article provides information on the changes found in Amendment 1 to the 6th Edition of UN 38.3, which details recommended testing to assess potential hazards associated with lithium-ion batteries in transit.
How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World
This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.
Mexico has published a new standard establishing updated energy efficiency requirements for certain lighting products. Published in January, the new standard, NOM-030-ENER-2016, specifies test methods for light... Read More...
Common FDA Regulatory Pathways for Uncommon Devices
After nearly four years of work, the International Organization for Standardization (ISO) has published an updated version of its standard for quality management systems used by medical device manufacturers. ... Read More...