標準號：BS EN ISO 10993-1-2009
中文標準名稱：醫療器械的生物學評估.風險管理過程評估和測試
英文標準名稱：Biological evaluation of medical devices - Evaluation and testing within a risk management process
標準類型：C37
發布日期：2010/6/30 12:00:00
實施日期：2010/6/30 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
適用范圍：This part of ISO 10993 describes:- the general principles governing the biological evaluation of medical devices within a risk managementprocess;- the general categorization of devices based on the nature and duration of their contact with the body;- the evaluation of existing relevant data from all sources;- the identification of gaps in the available data set on the basis of a risk analysis;- the identification of additional data sets necessary to analyse the biological safety of the medical device;- the assessment of the biological safety of the medical device.This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirectcontact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Otherparts of ISO 10993 cover specific tests, as indicated in the Foreword.