ISO 12891-1:2011 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. ISO 12891-1:2011 also provides guidance on infection control.
ISO 12891-1:2011 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.
Edition: 2 (Monolingual) ICS: 11.040.40 Status: Published Stage: 90.92 (2014-09-20) TC/SC: ISO/TC 150 Number of Pages: 23
Revised by: ISO/FDIS 12891-1
Revises: ISO 12891-1:1998