EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 14607 standard. EN ISO 14607 specifies special requirements for breast implants.
Regarding safety, this standard specifies requirements for intended performance, design features, materials, design evaluation, manufacturing, packaging, sterilization, and information provided by the manufacturer.
There are three International standard levels for inactive surgical implants. These are as follows (level 1 being the highest):
This standard is a level 2 standard and contains specific requirements for a family of breast implants. The level 1 standard, ISO 14630, contains requirements that apply to all inactive surgical implants. It also indicates that there are additional requirements at level 2 and level 3 standards.
EUROLAB assists manufacturers with EN ISO 14607 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.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
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.
