What Certification Tests Are Required For The Monitor Products? Whether Test Results Already Available In Country Of Origin Can Be Used？

At present, it is necessary to conduct performance parameter test, electromagnetic compatibility test (YY 0505-2012/IEC 60601-1-2:2004), electrical safety general standard test (GB 9706.1-2007/IEC 60601-1:1988 + A1 + A2, YY 0709-2009/IEC 60601-1-8:2003) and all the applicable standards of included monitoring functions, such as pulse function (YY 0784-2010/ISO 9919:2005), blood pressure function (YY 0667-2008/IEC 60601-2-30:1999), ECG monitoring function (GB 9706.25-2005/IEC 60601-2-27:1994), etc.
From May 1, 2023, China will implement the new version of GB 9706.1 standard equivalent to IEC 60601-1:2012 and the corresponding parallel standard and special standard, at which time the test will be conducted according to the new version of the standard. Currently only the test report of IEC 60601-1: 1988 + A1 + A2 can be used directly to avoid some test items. The corresponding policies for the implementation of the new standard in 2023 have not been clarified yet.