EN ISO 21534 Inactive Surgical Implants, Joint Replacement Implants, Special Requirements

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 21534 standard. ISO 21534 specifies specific requirements for full and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text.

For the purposes of this international standard, artificial ligaments and their associated fixation devices are included in the term "implant".

ISO 21534 specifies requirements for intended performance, design features, materials, design evaluation, manufacturing, sterilization, packaging, and information to be provided by the manufacturer.

There are three levels of international standards for inactive surgical implants. These are as follows, with level 1 being the highest:

• Level 1: General requirements for inactive surgical implants and instrumentation used in conjunction with implants;
• Level 2: Special requirements for inactive families of surgical implants;
• Level 3: Special requirements for inactive surgical implant types.

This international standard is a level 2 standard and contains requirements that apply to all inactive surgical implants in the family of joint replacement implants.

Level 3 standards apply to certain types of implants within a family, such as knee and hip joints. To meet all requirements, it is recommended to consult a standard of the lowest level available first.

EUROLAB assists manufacturers with EN ISO 21534 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.