CENELEC has finally made an official recommendation for the date to end the presumption of compliance with the device directives (harmonization) for the second edition." According to Schmidt, the withdrawal date is now officially set for June, 2012. This date aligns the regulatory use of the 60601-1 series in Europe and with the current policy of Health Canada. In the U.S., he says, FDA is expected to recognize the new standard within the next several months. The following link goes to a Q&A document on the CENELEC Web site: http://www.cenelec.eu/Cenelec/CENELEC+in+action/Horizontal+areas/ICT/Collateral_standards_under_MDD_AIMD.htm
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