ISO 12891-2, “Retrieval and analysis of surgical implants – Part 2: Analysis of retrieved surgical implants,” has just been updated. The new 2nd Edition replaces the first edition from 2000. The document also states that it cancels and withdraws the ISO 12891-3 and ISO 12891-4. However, ISO still shows these two parts as current right now. If you are involved in the retrieval or analysis of surgical implants, you’ll want to get a copy from Document Center now.
Of course, there’s many standards and regulations regarding the preparation of medical devices for implanting. However, the investigation of implants that are removed from patients can provide a wealth of information about performance, effectiveness, and the interaction of the device with the body. This knowledge then lends itself to improvements in devices themselves, biocompatibility, and functional longevity.
ISO 12891-1 provides the user with information on the proper retrieval and handling of surgical implants. ISO 12891-2 gives you the methodology for analysis and the protocols for reporting. It is used not only for implants used in humans, but those in animals as well. You will want to use the two documents in tandem, since material from one will impact the other.
After a brief discussion of retrieval, handling and packaging (primarily referencing part 1), the document focuses on two main areas: the analysis of the implant interfaces and analysis of the implant. Implant interfaces can be of two types: implant to tissue and implant to implant. Implant analysis itself is more detailed. It includes the various investigational stages:
- Stage 1 – Macroscopic, non-destructive examination
- Stage 2 – Microscopic, mostly non-destructive examination
- Stage 3 – Material, mostly destructive examination
Surface-treated or coated implants and biodegradable implants are also covered.
The last section deals with implant performance, while Annex A provides you with mandatory forms for reporting and Annex B gives you information on various ISO standards that are applicable for material evaluation. A 49-item Bibliography finishes up the standard.
If you’re using the ISO 12891 series, you’ll need a copy of the new ISO 12891-2. When you order from Document Center Inc., you’ll be able to get your copy in paper format, for pdf download or as part of our multi-user subscription service, Standards Online. Just go to our webstore, www.document-center.com, or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been providing standards to government and industry from our Silicon Valley location since 1982. Make us your Standards Experts!
