Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning.
This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact of this new standard and address updated requirements for the orthopedic industry.
Provided will be information on:
- Understanding the specific steps required to meet compliance of Applicable Standards and Regulatory requirements
- Validating the effectiveness of a cleaning process
- Addressing the challenges of combining subsets of chemical characterization tests, biological tests and microbiological tests to develop IQ/OQ/PQ
- Exploring various types of toxicological assessments to confirm safety and to determine acceptance criteria for subsequent routine testing