1-3. Reference Standards
The AJEX240H is manufactured according to the following standard.
- Related Korea Government Regulations & Standards
- 2007/47/EC ; Medical Device Directive
- EN 60601-1+A1+A2 : 1995
(Part 1:General requirements for safety)
- EN 60601-1-1 : 2000
(Collateral standard:Safety requirements for medical electrical systems)
- EN 60601-1-2 : 2007
(Collateral standard:Electromagnetic compatibility-Requirements and tests)
- EN 60601-1-3 : 2008
(Collateral standard:General requirements for radiation protection in diagnostic
X-ray equipment)
- EN 60601-1-4 : 2004
(Collateral standard:Programmable electrical medical system)
- EN 60601-2-7 : 1998
(Part 2-7:Particular requirement for the safety of high-voltage generators of
diagnostic X-ray generators)
- EN 60601-2-28 : 1993
(Part 2:Particular requirement for the safety of X-ray source assemblies and
X-ray tube assemblies of medical diagnosis)
- ISO 14971:2007 ; Risk management
- Others : Related standards (Government regulations, IEC, ISO etc. ) for the
graphic symbols, risk management, quality system, etc.
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AJEX240H / Operating instructions
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AXR-240H-MN01 (E) / Rev. 03