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SS EN ISO 10993-1 Ed. 4 (2009)现行

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

出版：Standardiserings-Kommissionen I Sverige

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基本信息

标准编号： SS EN ISO 10993-1 Ed. 4 (2009)

发布时间：2009/10/26 0:00:00

标准类别：Standard

出版单位：Standardiserings-Kommissionen I Sverige

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 SS EN 30993-1. (03/2002) 2ED 2004 is still active. (02/2010)

本标准替代的旧标准

SS EN ISO 10993-1 Ed. 2 (2004)

SS EN 30993-1:1994

等同采用的国际标准

UNE EN ISO 10993-1:2010 - Identical

SN EN ISO 10993-1:2010 - Identical

UNI EN ISO 10993-1:2010 - Identical

NF EN ISO 10993-1:2010 - Identical

ONORM EN ISO 10993-1:2011 - Identical

UNE EN ISO 10993-1:2004 - Identical