2013 June 30 onwards, medical products into the U.S. market to be in accordance with FDA requirements,

proposed accord ES60601-1 file.

ES60601-1 corresponds to the IEC60601-1 3rd Edition, mainly invited described as follows:

1. New design products are required to meet ES60601-1 Third Edition.

2. Existing products in the market , to continue to sell , you need to meet ES60601-1 Third Edition.

3. ES60601-1 requires manufacturers need to do a risk assessment management , quality systems

    and the corresponding need to meet the requirements of the design process.

These requirements are detailed in FDA announcement the following address:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30508