To those related enterprise,
The Medical electrical equipment - Part 1:General requirements for safety (GB9706.1-2007), Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (GB 9706.15-2008), Cardiovascular implants and artificial organs－Extracorporeal blood circuit for blood purification devices (YY0267-2008) and Cardiovascular implants and artificial organs－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (YY0053-2008) has been promulgated and implemented，to instead of GB9706.1-1995,GB9706.15-1999,YY0267-1995 and YY0053-91 respectively. The details as following,
|
New Standard |
Old Standard |
Issued Date and Implemented Date |
Applicable Products |
|
Medical electrical equipment - Part 1:General requirements for safety GB9706.1-2007 |
Medical electrical equipment - Part 1:General requirements for safet GB9706.1-1995 |
Issued on July 2nd, 2007/ Implemented on July 1st, 2012 |
Electrocardiographs |
|
Haemodialysis equipment | |||
|
Medical X-ray Diagnostic Equipment | |||
|
Artificial heart-lung machine-Roller blood pump | |||
|
Artificial Heart-Lung Machine Pulsatile Roller Pump | |||
|
Artificial heart-lung machine-Heat exchanging water tank | |||
|
Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical system GB 9706.15-2008 |
Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems GB9706.15-1999 |
Issued on Dec. 15th , 2008 / Implemented on Feb. 1st,2010 |
Medical X-ray Diagnostic Equipment |
|
Cardiovascular implants and artificial organs－Extracorporeal blood circuit for blood purification devices YY0267-2008 |
Extracorporeal blood circuit for blood purification devices YY0267-1995 |
Issued on Apr. 25th, 2008/ Implemented Dec.1st, 2009 |
Extracorporeal blood circuit for blood purification devices |
|
Cardiovascular implants and artificial organs－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators YY0053-2008 |
Cellulose triacetate hollow fiber dialyzers YY0053-91 |
Issued on Apr. 25th, 2008/ Implemented Dec.1st, 2009 |
Cellulose triacetate hollow fiber dialyzers |
1. New standard has been implemented on related products in CQC since the new version released.
2. For the products which are not certified by new standards should submit changing application since the notice released, and taken sample for type test as needed and complete confirmation according to new standard. Certificate modification should be finished before the first follow-up inspection since this notice released, it will be suspended if conversion is overdue. The modification should be finished no later than July, 1st, 2013. or original certificate will be suspended. If conversion can not complete before Dec. 1st, 2013, it will be withdrawn by CQC.
3. For the products have been delivered before new standard released, put into market and no longer to produce without needs to convert.
Tel:0086-10-83886472
China Quality Certification Centre
Aug. 17th , 2012
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