Verification of electrical safety testing equipment is a procedure that is often overlooked by manufacturers. Running test verification is crucial to ensuring that a safety device will properly detect product failures. While the task of setting up a test verification can seem daunting, it’s a simple matter of having the necessary equipment and procedures in place so that the process is easy to follow.
ESD qualification requirements for systems rely heavily on discharge models such as IEC61000-4-2.
This article will summarize the major changes of the new revision of ISO/IEC 17025-2005, present the new outline of the standard and will discuss the new concept of a “risk-based” approach of implementing requirements.
Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.
ISO 26262 requires a variety of processes and frameworks for safety management, safety concept development, requirements flow-down, and verification & validation activities.
Transported lithium-based batteries are divided into two types: lithium-ion found in mobile phones and laptops, and non-rechargeable lithium-metal used in medical devices and a number of consumer grade AA, AAA and 9V batteries.