The way you market your product can turn an otherwise safely designed product into an unsafe product that causes injury and creates liability for the manufacturer and product seller.
This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.
As the global market for LED horticultural luminaires grows, it is important for the industry to assess these products for safety and performance considerations unique to their controlled indoor agricultural environments. The industry is responding by introducing standards and programs with a variety of requirements.
This article examines how the expanded use of commercial drones will impact U.S. regulatory requirements and how the current legislative landscape might change as the market expands.
This article discusses additional requirements that designers and safety professionals may want to consider beyond the base standard for their product based on the environment and user exposure.
This article provides an overview of current standards applicable to rechargeable lithium and lithium-ion batteries.
Challenges and Directions for Lifecycle Processes Supporting Conformity Assessment of Interoperable Medical Products
This article provides an overview of lifecycle issues for interoperable medical products that are not sufﬁciently addressed in existing medical device standards and identifies lifecycle concepts from other domains that may be adapted for interoperable medical systems.
Product liability litigation and product safety regulatory compliance are sometimes intertwined, and this can make a bad situation worse.
Wireless devices are now in the legislative spotlight the world over. Safety, performance, spectrum usage and protection of personal data are all matters of regulation, although countries vary in how they regulate such concerns. This article looks at Australia as a case study, reviewing the overarching legal framework, the role of the national regulator, conformity assessment and the use of standards.
South Korea has several mandatory product certifications covering many different product categories. The most important one is the KC certification, which applies to a large variety of products and is comprised of different certification modes.