This International Standard, with its several parts, gives recommendations for the retrieval, handling and analysis of surgical implants, medical implants and associated specimens which are removed from patients routinely, during revision surgery, or post mortem. The aim is to provide guidance in preventing damage to the associated specimens which could obscure investigation results, and in gathering data at the proper time and circumstance to validate the study.

ISO 12891-1 is intended to be the overall guidance document for the retrieval and handling of surgical implants, ensuring their safe and proper retrieval, sterilization and handling.

In the associated parts of this International Standard, protocols for the collection of data and examinations are provided for specific types of material in relation to their typical applications. For particular investigation pro-grammes, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures need to be specified.

This part of ISO 12891 should be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues.