ISO 10993-1:2018 医疗器械的生物学评价 第1部分：在风险管理过程内的评价与试验

标准编号：ISO 10993-1:2018

中文名称：医疗器械的生物学评价 第1部分：在风险管理过程内的评价与试验

英文名称：Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

发布日期：2018-08

标准范围

This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk 
management process;
— the general categorization of medical 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 document applies to evaluation of materials and medical devices that are expected to have direct 
or indirect contact with: 
— the patient's body during intended use;
— the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and 
others). 
This document is applicable to biological evaluation of all types of medical devices including active, 
non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety 
assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or 
novel materials. 
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-
specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform 
encephalopathy (TSE) agents and other pathogens.

标准预览图