標準號：ISO 12891-1-2011
中文標準名稱：外殼植入物.外科植入物的分析和取出.第1部分:取出和處理
英文標準名稱：Implants for surgery - Retrieval and analysis of surgical implants - Part 1: Retrieval and handling
標準類型：C45
發布日期：2011/5/1 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40
適用范圍：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.