EN 60601-2-54
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DIN EN 60601-2-54 |
|---|---|
| Area | Medical technology |
| title | Medical electrical equipment - Part 2-54: Particular requirements for the safety and essential performance of X-ray equipment for radiography and radioscopy |
| Latest edition | 10.2008 (draft) |
| ISO | IEC 60601-2-54: 2008 |
The EN 60601-2-54 titled "Part 2-54: Particular requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy" is part of the series of standards EN 60601 .
The DIN standard DIN EN 60601-2-54 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-2-54. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-54 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of X-ray equipment for radiography and radioscopy. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application.
validity
- The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
- Appeals could be made until December 31, 2008.
scope of application
This international standard applies to the basic safety and essential performance characteristics of ME devices and ME systems intended for use in projection radiography and radioscopy . Requirements for precautions specifically for ME devices and ME systems intended for interventional applications are contained in the special provisions EN 60601-2-43 ; here changes or deletions have been made to the requirements in EN 60601-2-54.
ME devices or ME systems that are intended for use at
- Bone or tissue absorption density measurement,
- Computed tomography ,
- Mammography ,
- Dental application ,
are excluded from the scope of this international standard. The scope of this international standard also excludes radiotherapy simulators.
extra information
The standard is still in the drafting stage. The following changed requirements are contained in EN 60601-2-54 (excerpt):
- Requirements for the supply network
- Protection against electrical hazards
- Protection against mechanical hazards (collisions, movement, mechanical strength)
- Protection from radiation
- Protection against dangerous initial values
- Constructive requirements
- Measurement regulations
- Reference to the application of EN 60601-1-3