标准编号:ISO 12891-1:2011

中文名称:外科植入物 外科植入物的取出与分析 第1部分:取出与处理

英文名称:Implants for surgery — Retrieval and analysis of surgical implants — Part 1: Retrieval and handling

发布日期:2011-05

标准范围

This part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical implantsand associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe andproper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling,cleaning, decontamination, documentation, packing and shipping. This part of ISO 12891 also providesguidance 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 retrievaldata. However, many clauses give useful information which can apply in these cases also.

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