What is ISO 12891-2 about?
ISO 12891 discusses retrieval and analysis of surgical implants. ISO 12891-2 outlines methods for the analysis of retrieved surgical implants.
ISO 12891-‑2 describes the analysis of retrieved metallic, polymeric, and ceramic implants. The analysis is divided into three stages that are increasingly destructive.
ISO 12891-2 can also be applied to other materials, e.g., animal tissue implants.
Note: National regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material can also apply to specific topics covered in ISO 12891-2.
Who is ISO 12891-2 for?
ISO 12891-2 on analysis of retrieved surgical implants is useful for:
- Manufacture of surgical implants
- Medical laboratories for surgical implants
- Regulatory authorities
Why should you use ISO 12891-2?
The investigation of retrieved implantable medical devices and adjacent tissues can be of diagnostic value in the event of clinical complications. And can deepen our knowledge of clinical implant performance and safety. And can improve our understanding of the interactions between implants and the body.
ISO 12891-2 guideline helps you with analysis of the implant interfaces, analysis of the implant, visual examination, microscopic examination, mechanical properties, and investigation on non-destructive, mostly non-destructive, and most destructive macroscopic examination. ISO 12891-2 also provides information on surface-treated or coated implants, Biodegradable implants, and procedure for retrieval, handling, and packaging. This helps in improving biocompatibility, functional longevity, performance, and safety of surgical implants.
What’s changed since the last update?
BS ISO 12891-2:2020 supersedes ISO 12891-2:2014, which has been withdrawn. BS ISO 12891-2:2020 has some technical changes with respect to ISO 12891-2:2014. These include:
- Normative references have been updated
- Editorial improvements have been made to the language of ISO12891-2.
