標(biāo)準(zhǔn)號(hào)：DIN EN ISO 10993-17-2009
中文標(biāo)準(zhǔn)名稱：醫(yī)療器械的生物學(xué)評(píng)定.第17部分:可浸出物質(zhì)容許限值的確定(ISO 10993-17-2002);德文版本EN ISO 10993-17-2009
英文標(biāo)準(zhǔn)名稱：Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); English version of DIN EN ISO 10993-17:2009-08
標(biāo)準(zhǔn)類型：C30
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：2009/8/1 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：C30
國(guó)際標(biāo)準(zhǔn)分類號(hào)：11.100.20
適用范圍：This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable frommedical devices. It is intended for use in deriving standards and estimating appropriate limits where standards donot exist. It describes a systematic process through which identified risks arising from toxicologically hazardoussubstances present in medical devices can be quantified.This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).Exposure to a particular chemical substance may arise from sources other than the device, such as food, water orair. This part of ISO 10993 does not address the potential for exposure from such sources.