BS ISO 12891-1:2015 - Page 2

Retrieval and analysis of surgical implants. Retrieval and handling | Status: Current, Project Underway

1 Scope This part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. This part of ISO 12891 also provides guidance on infection control.

NOTE National or other regulations, which can be more stringent, can apply.

This part of ISO 12891 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.