Abstract
ISO 12891-1:2015 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. It also provides guidance on infection control.
NOTE National or other regulations, which can be more stringent, can apply.
ISO 12891-1:2015 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.
General information
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Status: PublishedPublication date: 2015-07Stage: International Standard to be revised [90.92]
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Edition: 3Number of pages: 24
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Technical Committee :ISO/TC 150ICS :11.040.40
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Life cycle
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Previously
WithdrawnISO 12891-1:2011
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Now
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Will be replaced by
Under developmentISO/AWI 12891-1