Lanmage 6600C - Protection against Hazards from Unwanted or Excessive Radiation; Electromagnetic Compatibility

6600 Product Manual
Operator Manual
9
3
EN 60601-1-3
Medical electrical equipment - Part 1-3: General requirements
for safety - collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
4
EN 60601-1-6
Medical electrical equipment –Part 1-6: General requirements
for basic safety and essential performance –Collateral
standard: Usability.
5
EN 62366-1
Medical device –Part 1: Application of usability engineering to
medical devices
6
EN 60601-2-54
Medical electrical equipment -- Part 2-54: Particular
requirements for the basic safety and essential performance
of Xray equipment for radiography and radioscopy
7
EN 62304
Medical device software – Software life-cycle processes.
8
EN ISO 14971
Medical devices- Application of risk management to medical
devices.
9
EN ISO 15223-1
Medical devices - symbols to be used with medical device
labels, labeling and information to be supplied.
10
EN 1041
Information Supplied by the Manufacturer for Medical Devices
11
EN ISO 10993-1
Biological evaluation of medical devices—Part 1：Evaluation
and testing within a risk management process.
According to IEC60601-1-2, this unit is equipped with EMC filters. The lack of proper
grounding may produce electrical shock to the user.
2.7 Protection against hazards from unwanted or excessive radiation
Statement of compliance: x-ray unit with radiation protection in accordance with IEC
60601-1-3.
2.8 Electromagnetic compatibility
ATTENTION
⚫ (Equipment or system)meets the requirements of EN 60601-1-2 standard
electromagnetic compatibility;