Standard
ISO 21534
Non-active surgical implants — Joint replacement implants — Particular requirements
Specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. Specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.
Our Testing Services
When choosing a medical device testing laboratory to perform evaluations, there are four key elements to consider:
- Interaction with a senior engineer to review the intricacies of the device and to ensure the proposed testing will address corporate goals and objectives
- Accurate implementation of the testing standard(s)
- Comprehensive reporting of the materials, procedures and data to align with ASTM/ISO and USFDA reporting requirements
- Regularly scheduled and documented verification, calibration and maintenance of testing equipment
ORL does all of the above, always has, and laid the groundwork for many of today’s active standards!
