標(biāo)準(zhǔn)號(hào)：DIN EN ISO 10993-6-2017
中文標(biāo)準(zhǔn)名稱(chēng)：醫(yī)療設(shè)備的生物學(xué)評(píng)價(jià).第6部分:植入后局部效果試驗(yàn)(ISO 10993-6-2016);德文版本EN ISO 10993-6-2016
英文標(biāo)準(zhǔn)名稱(chēng)：Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
標(biāo)準(zhǔn)類(lèi)型：C30
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類(lèi)號(hào)：C30
國(guó)際標(biāo)準(zhǔn)分類(lèi)號(hào)：11.100.20
引用標(biāo)準(zhǔn)：DIN EN ISO 10993-1-2010;DIN EN ISO 10993-2-2006;DIN EN ISO 10993-4-2009;DIN EN ISO 10993-12-2012;DIN EN ISO 10993-16-2010;ASTM F 748-2016;ASTM F 763-2004;ASTM F 981-2004;ASTM F 1983-2014;ISO 5832-1-2016;ISO 5832-2-1999;ISO 5832-3-2016;ISO 5832-4-2014;ISO
適用范圍：This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. The test specimen is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test specimen in terms of mechanical or functional loading. This part of ISO 10993 may also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining may have been breached, in order to evaluate local tissue responses. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by control materials used in medical devices of which the clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or resorption/degradation of the material. In particular for degradable/resorbable materials the degradation characteristics of the material and the resulting tissue response should be determined. This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity.