ISO 12891-1:2011 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

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

ISO 12891-1:2011规定了取出和处理外科植入物及相关组织和液体的方法。特别是，它规定了安全、适当地获取临床病史、移植前检查和检查、收集、贴标签、清洁、去污、记录、包装和运输所需遵循的基本步骤。ISO 12891-1:2011还提供了感染控制指南。ISO 12891-1:2011不适用于无意收集检索数据的外植情况。然而，许多条款提供了有用的信息，这些信息也适用于这些情况。

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.

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