The U.S. Food and Drug Administration (FDA) has issued final guidance in supporting claims of electromagnetic compatibility (EMC) of medical devices. The document is recommended for use in conjunction with consensus standards, as well as other FDA guidance documents pertaining to specific devices. Typically, the FDA reviews EMC information based on the risk of device … [Read more...]
Standards
FCC Releases Updated LED Lighting EMC Guidance
(June 17, 2016) Effective June 17, 2016, all RF LED lighting devices, including those that have been considered to operate on frequencies below 1.705 MHz, are now required to have Radiated Emissions measurements performed at a minimum from 30 MHz to 1000 MHz. Radio frequency (RF) light-emitting diode (LED) lighting products are subject to FCC rules to ensure that devices do … [Read more...]
ETSI Releases Draft Standard for Low Power Medical Implants
(July 1, 2016) The present document together with ETSI EN 301 489-1 [1] covers the assessment of all radio transceivers associated with inductive Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated external radio apparatus (ULP-AMI-Ps) transmitting in the frequency range of 9 kHz to 315 kHz … [Read more...]
IEC 60601-1-9 – Environmentally Conscience Design for Medical Equipment
The standard for environmentally conscious design, IEC 60601-1-9, was published in 2007 (amended in 2013) as a collateral standard to IEC 60601, the widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Compliance with the IEC 60601 series is required by regulatory bodies responsible for electrical … [Read more...]
South African EMC Compliance Outlined
Manufacturers and importers of electronic equipment can expect a “transparent, predictable and efficient process” when applying for Electromagnetic Interference/ Compatibility (EMI/EMC) Certificates of Compliance (CoCs), South African Bureau of Standards (SABS) CEO Dr. Boni Mehlomakulu said.A memorandum of understanding (MOU) between the SABS and the Independent Communications … [Read more...]
List of Common EMC Standards
You shouldn’t be surprised that Wikipedia has a comprehensive list of EMC standards. The list includes CISPR, IEC, ISO, European EN, FCC, and MIL-STD. There is also a link to the GR-1089-CORE EMC and product safety standards for network telecommunications equipment. A good link to bookmark. Click here. … [Read more...]
Keeping Up-to-Date with CISPR Standards
Rohde & Schwarz has recently published a recent summary of current CISPR standards, new amendments, and dates of mandatory compliance. They also explain some of the new test methods and equipment allowable, such as the faster FFT-based EMI receivers. Download your copy here. … [Read more...]
The ANSI-ASC-C63® Workshop July 22-23, 2016, in Ottawa
Topics to be presented include ANSI C63.4, CISPR 22, and ANSI C63.25. Don Heirman, Jason Nixon (special guest speaker from Innovation, Science and Economic Development – ISED - Canada, formerly Industry Canada) and Zhong Chen are presenting. This combined workshop is presented in two parts over a two day period. Topics covered include: (1) review of the 2014 edition of ANSI … [Read more...]
CISPR 35 Up for Final Vote
The final draft international standard (FDIS) for CISPR 35 has just been circulated to national Committees, with a closing date for voting of July 8 2016. It is dual-voted in CENELEC as well, but it might pass in IEC but not in CENELEC, so the future of the EN clone, EN 55035, is still somewhat uncertain. CISPR 35 is a new standard for broadcast receivers, information … [Read more...]
Complying with the New EMC Directive
Editor's Note: The following reply was received from Keith Armstrong, EMC consultant in the UK, to a news item we ran in the May 12th newsletter regarding complying with the new EMC Directive. We welcome reader comments to our articles. Armstrong writes, "I see lots of test labs publishing over-simplified guidance on complying with the new EMC Directive, including the one by … [Read more...]
