Within the scope of accreditation by DAkkS/ILAC (DIN EN ISO/IEC 17025) and the IECEE-CB procedure, SGS Germany GmbH offers the entire range of product safety and EMC tests as well as certifications for X-ray devices and systems for medical diagnostics.
X-ray equipment, like all electrical medical devices, must also fulfill general safety requirements in accordance with IEC 60601-1, which are completed by usability requirements. In addition, the IEC 60601-1-3 standard specifies the radiological protection requirements for diagnostic X-ray equipment and IEC 60601-2-28 regulates these for the safety of X-ray sources and their diaphragm systems.
Alongside the general requirements that X-ray equipment must meet, there are also special conditions that result from the particular intended use. The IEC 60601-2-43 standard refers to the requirements for X-ray equipment for interventional procedures, while IEC 60601-2-44 applies to those for computer tomography. The mammography procedure is important for the early detection of breast cancer. The special X-ray equipment and stereotactic equipment must fulfill IEC 60601-2-45; X-ray equipment for radiography and radioscopy must comply with IEC 60601-2-54. In the field of dentistry, a categorization is made between extraoral and intraoral X-ray equipment. The requirements for these are set out in IEC 60601-2-63 and IEC 60601-2-65, respectively.
The laboratories and test experts at SGS Germany GmbH have the appropriate expertise to test and certify X-ray devices and equipment of this type. Testing with X-ray operation can be carried out both at our site in Munich with an existing radiation protection organization (radiation protection officer) and as part of the manufacturer’s process within the verified premises of the distributor.
Contact
Armin Hudetz
Tel.: +49 89 78 74 75-133
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Customer Service Team
Tel.: +49 89 78 74 75-222
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