GB 16174.1-2015 Implants for surgery.Active implantable medical devices.Part 1:General requirements for safety,marking and for information to be provided by the manufacturer (English Version)
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest
GB 16174.1-2015
Scope
This part of GB 16174 specifies the general requirements applicable to active implantable medical devices. The tests specified in this standard are type tests, which are carried out on samples to demonstrate the conformity of the product. These tests are not intended to be used for routine testing of manufactured products. This section applies not only to electrically powered active implantable medical devices, but also to active implantable medical devices powered by other energy sources (such as gas pressure or springs). This standard also applies to certain non-implantable components and accessories of active implantable medical devices (see 3.3).
GB 16174.1-2015 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
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GB/T 17626.2-2006 Electromagnetic compatibility Testing and measurement techniques Electrostatic discharge immunity test
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 2423.22-2002 Environmental testing for electric and electronic products--Part 2: Test methods Test N: Change of temperature
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GB/T 2423.56-2006 Environmental testing for electric and electronic products-Part 2:Test methods-Test Fh:Vibration,broad-band random(digital control) and guidance
GB/T 2423.8-1995 Environmental testing for electric and electronic products. Parts 2: Test methods. Test Ed: Free fall
GB/T 7408-2005 Data elements and interchange formats-Information interchange-Representation of dates and times
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY 0505-2012 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
YY/T 0297-1997 Clinical investigation of medical devices
YY/T 0708-2009 Medical electrical equipment.Part 1-4:General requirements for safety.Collateral standard:programmable electrical medical systems
GB 16174.1-2015 history
2015GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers