EN 60601-1-3
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DIN EN 60601-1-3 |
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| Area | Medical technology |
| title | Medical electrical equipment - Part 1-3: General requirements for safety including the essential performance characteristics - Supplementary standard: Radiation protection of diagnostic X-ray equipment |
| Latest edition | 12/2008 |
| ISO | IEC 60601-1-3: 2008 |
The EN 60601-1-3 entitled "Electrical Medical devices - Part 1-3: -: Radiation protection in diagnostic X-ray equipment collateral standard General requirements for basic safety and essential performance" is part of the series of standards EN 60601 .
The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-1-3 .
The standard is based on the international version IEC 60601-1-3. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-3 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for safety, tests and guidelines for diagnostic X-ray devices .
validity
The German edition 4.2001 is accepted as a German standard from the date of its publication .
- The current version (12/2008) is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
- The previous standard 2.1995 is to be used in accordance with the 2nd edition of DIN EN 60601-1.
- Until all the sub-standards applicable to the device to be tested have been adapted to the 3rd edition of EN 60601-1, the version from February 1995 may still be used.
scope of application
This supplementary standard applies to X-ray devices and assemblies of such devices that use radiological images of the human patient for diagnosis, planning or to support medical procedures.
extra information
The following changed requirements are contained in EN 60601-1-3 (extract):
- Radiation protection
- Construction of the radiator
- Radiation limitation