EUROLAB laboratory provides testing and compliance services within the scope of ISO 9583 standard. This International standard establishes a method for the detection and assessment of defects induced by liquid penetrating on the surfaces of metallic surgical implants.
Liquid penetrant examination of metallic surgical implants shall be performed in accordance with ISO 3452 using the penetrant systems classified there.
Contamination of the emulsifier by penetrating should not exceed 10%. The concentration of the penetrant should be checked with a refractometer. For each emulsifier or emulsifier concentration used, a calibration must be performed to determine the refractometer correction.
Normal, high or very high precision penetrating material systems will be used according to the type, stress category, material and manufacturing stage of the implant. The sensitivity level will be determined by the manufacturer or buyer. The frequency of testing should be weekly or prior to use, whichever of the two alternatives is more frequent.
Examination results will be documented in a way that is traceable to the implants examined. Ultraviolet radiation lamps used for fluorescent penetrant inspection shall be checked for ultraviolet radiation output in accordance with ISO 3059. The testing frequency will be weekly.
The manufacturer or buyer's acceptance and rejection criteria should define the type, size and separation of acceptable defects in relation to the inspection area. For this, the manufacturer or purchaser must specify the different inspection areas of metallic surgical implants on the drawings.
EUROLAB assists manufacturers with ISO 9583 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
