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UNI EN ISO 10993-1:2010现行

Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process

出版：Italian Standards

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基本信息

标准编号： UNI EN ISO 10993-1:2010

标准类别：Standard

出版单位：Italian Standards

标准页数：0

标准简介

Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - 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.

标准备注

Supersedes UNI EN 30993-1 (07/1999)

本标准替代的旧标准

UNI EN ISO 10993-1:2009

等同采用的国际标准

NBN EN ISO 10993-1:2009 - Identical

I.S. EN ISO 10993-1:2009 - Identical

NS EN ISO 10993-1:2009 - Identical

SS EN ISO 10993-1 Ed. 4 (2009) - Identical

ONORM EN ISO 10993-1:2010 - Identical

DIN EN ISO 10993-1 (2010-04) - Identical

BS EN ISO 10993-1:2009 (October) - Identical