EN 60601-2-43
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DIN EN 60601-2-43 |
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| Area | Medical technology |
| title | Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures. |
| Latest edition | 2011-03 |
| ISO | - |
The EN 60601-2-43 titled "Electrical Medical devices - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures" is part of the series of standards EN 60601 .
The DIN standard DIN EN 60601-2-43 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-2-43. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-43 , see DIN-VDE standards part 7 .
This supplementary standard regulates general specifications for the safety, tests and guidelines of X-ray equipment for interventional procedures. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.
validity
The German edition of March 2011 has been accepted as a German standard from the date of its publication .
scope of application
These special stipulations apply to X-ray equipment that, according to the manufacturer's declaration, is suitable for long-term fluoroscopic interventional procedures. In particular, the following are excluded from the scope of application:
- Facilities for radiotherapy
- Equipment for computed tomography
- Accessories to be inserted into the patient;
- X-ray equipment for mammography .
In the annex to the standard, examples are given of long-term fluoroscopic interventional procedures for which the use of devices that meet the requirements of this standard is recommended.
The special requirements of this standard are not essential for all devices that are used for fluoroscopic interventional procedures. Examples are given of procedures for which the use of equipment complying with this standard is not considered essential.
Devices that, according to the manufacturer's declaration, are suitable for fluoroscopic interventional procedures and are not equipped with a patient positioning aid as part of the system are excluded from the provisions of this standard with regard to patient positioning aids.
extra information
The following changed requirements are contained in EN 60601-2-43 (excerpt):
- Protection against mechanical hazards (mechanical strength)
- Protection from radiation
- Protection against ingress of liquids
- Protection against dangerous initial values
- Constructive requirements