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SFDA : Electromagnetic compatibility standard medical electrical equipment issued

Mar
18
2013
SFDA : Electromagnetic compatibility standard medical electrical equipment issued

“In order to better ensure the safety of medical devices, the State Food and Drug Administration (SFDA) organized the National Medical Electrical Equipment Standardization Technical Committee to complete the drafting of the industry standard for medical devices YY 0505-2012 “Medical electrical equipment—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests (IEC 60601-1-2: 2004, IDT)”. The Standard was issued on December 17, 2012 and will be put into practice as of January 1, 2014. As a basic general safety standard which is parallel with GB 9706.1 “Medical electrical equipment—Part 1: General requirements for safety”, YY 0505-2012 is a mandatory industry standard for medical electric equipment.”

Source : www.sfda.gov.cn                     Publication date : 2013-03-14