DIN EN ISO 10993-6-2009 医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO 10993-6-2007); 德文版本 EN ISO 10993-6-2009

百检网 2021-07-20
标准号:DIN EN ISO 10993-6-2009
中文标准名称:医疗设备的生物学评价.第6部分:植入后局部效果试验(ISO 10993-6-2007); 德文版本 EN ISO 10993-6-2009
英文标准名称:Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); English version of DIN EN ISO 10993-6:2009-08
标准类型:C30
发布日期:1999/12/31 12:00:00
实施日期:2009/8/1 12:00:00
中国标准分类号:C30
国际标准分类号:11.100.20
引用标准:ISO 10993-1-2003;ISO 10993-2;ISO 10993-11;ISO 10993-12;ISO 10993-16
适用范围:This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation ofbiomaterials intended for use in medical devices.This part of ISO 10993 applies to materials that are:-- solid and non-biodegradable;-- degradable and/or resorbable;-- non-solid, such as porous materials, liquids, pastes and particulates.The test specimen is implanted into a site and animal species appropriate for the evaluation of the biologicalsafety of the material. These implantation tests are not intended to evaluate or determine the performance ofthe test specimen in terms of mechanical or functional loading. This part of ISO 10993 may also be applied tomedical devices that are intended to be used topically in clinical indications where the surface or lining mayhave 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 thatcaused by control materials used in medical devices of which the clinical acceptability and biocompatibilitycharacteristics have been established. The objective of the test methods is to characterize the history andevolution of the tissue response after implantation of a medical device/biomaterial including final integration orresorption/degradation of the material. In particular for degradable/resorbable materials the degradationcharacteristics 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.However, the long-term implantation studies intended for evaluation of local biological effects may provideinsight into some of these properties. Systemic toxicity studies conducted by implantation may satisfy therequirements of this part of ISO 10993.

百检能给您带来哪些改变?

1、检测行业全覆盖,满足不同的检测;

2、实验室全覆盖,就近分配本地化检测;

3、工程师一对一服务,让检测更精准;

4、免费初检,初检不收取检测费用;

5、自助下单 快递免费上门取样;

6、周期短,费用低,服务周到;

7、拥有CMA、CNAS、CAL等权威资质;

8、检测报告权威有效、中国通用;

客户案例展示

  • 上海朗波王服饰有限公司
  • 浙江圣达生物药业股份有限公司
  • 天津市长庆电子科技有限公司
  • 上海纽特丝纺织品有限公司
  • 无锡露米娅纺织有限公司
  • 东方电气风电(凉山)有限公司