Date: August 15, 2011
CSA, a leading testing and certification organization, today announced that its Montreal facility was recognized by ANSI accreditation services as the first official certification body facility in the world to be accredited to the third edition of ANSI/AAMI ES 60601-1:2005 Medical Electrical Equipment Standard.
The adopted ANSI/AAMI ES 60601-1 is a safety standard for electro-medical equipment. The scope of the standard covers medical devices requiring an electrical outlet or a battery. The purpose of this standard is to ensure that medical equipment manufacturers have addressed basic safety and essential performance through risk management.
“We are proud and delighted to be the first organization in the world to offer this new certification service to all our global electro-medical clients for the U.S. market,” said Ash Sahi, President and CEO, CSA Group. “The new certification service is available throughout our North American and European offices and will help our global clients to have an advantage to meet the new safety requirements in the fast evolving electro-medical market.”
The third edition, published in 2005, has an FDA compliance date of July 1, 2013 for U.S. medical device licensing. A major upgrade in the third edition is a clause requiring manufacturers to have a formal risk management process in place which complies with ISO 14971 in determining the safety of a specific medical device during its complete life cycle.
About CSA International
CSA International is a provider of product testing and certification services for electrical, mechanical, plumbing, gas and a variety of other products. Recognized in the U.S., Canada and around the world, CSA International certification marks appear on billions of products worldwide. CSA International is a division of CSA Group, which also includes CSA Standards, a leading solutions based standards organization, providing standards development, application products, training and advisory services; and OnSpeX, a provider of consumer product evaluation, inspection and advisory services for retailers and manufacturers. For more information, visit www.csa-international.org
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