Chang-Hong Whitney10.06.06
First it should be noted that GB9706.1 – 1995 Medical Electrical Equipment – Part 1: General Requirements for Safety is identical to IEC60601.1-1988. It originally was issued in 1997 as a recommended standard for electrical products.
This standard deals with 110 tests that cover issues such as environmental safety, electric shock protection, mechanical safety protection, RF radiation protection, flammable protection, extreme working conditions and structural design.
Before the standard became mandatory in May—after policy No. [2006] 259 was issued—most SFDA testing centers already had begun conducting 61 of the 110 tests as part of the testing process. After compliance with the standard became mandatory, however, SFDA testing centers were required to conduct all 110 tests on all electronic products.
In accordance with this standard, manufacturers of products that have been on the market prior to this new policy now are required to conduct the full gamut of testing on their products and submit results to the SFDA before the end of 2007.
There is one caveat to this requirement, though. If a registered product previously had been tested by an agency certified by the International Electrotechnical Commission, the SFDA will accept the full IEC testing report in lieu of repeating the additional 49 tests at SFDA testing centers. Of course, manufacturers that have not completed the complete lot of IEC tests by other certification agencies must test their products.
