Standards by Topic

CISPR 11: A Historical and Evolutionary Review

CISPR 11 is the International Standard for electromagnetic emissions (disturbances) from Industrial, Scientific and Medical (ISM) Equipment. The official title of the standard is “Industrial, Scientific, and Medical Equipment – Radio-Frequency Disturbance Characteristics – Limits and Methods of Measurement.” The premiere edition of the standard was released in 1975 and the latest edition (Edition 5.0) was released in 2009. The standard includes both limits and methods of measurement for conducted phenomena and radiated phenomena. This article traces the history and development of the content of the standard over the last 35 years.

Tailoring MIL-STD-461 RE102

This article describes the parameters that can be used to tailor your application of MIL-STD-461 RE102, such as frequency ranges, designing notches, and relaxing limits.

A Circuit Model for the Charged Device Model Spark

The charged device model spark itself is not just resistive; it often has extra inductance or L-C energy storage. These plus hardware properties affect the CDM waveform and affect methods to correlate alternate CDM test methods to standard JEDEC CDM.

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

FDA Adds Vaporized Hydrogen Peroxide as Established Sterilization Method for Medical Devices

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.
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MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a...

FDA Issues Guidance on Electronic Submissions of 510(k)s

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket...

FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its...

FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity...

FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final guidance document on...
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