BS EN ISO 16061-2009 与非有源外科植入物共同使用的器械.一般要求

百检网 2021-08-05
标准号:BS EN ISO 16061-2009
中文标准名称:与非有源外科植入物共同使用的器械.一般要求
英文标准名称:Instrumentation for use in association with non-active surgical implants - General requirements
标准类型:C35
发布日期:2009/12/31 12:00:00
实施日期:2009/12/31 12:00:00
中国标准分类号:C35
国际标准分类号:11.040.40;11.040.99
引用标准:ISO 11135-1;ISO 11137-1;ISO 11137-2;ISO 11137-3;ISO 11607-1;ISO 11607-2;ISO 14155-1;ISO 14155-2;ISO 14971;ISO 15223-1;ISO 17664;ISO 17665-1;EN 556-1;EN 556-2;EN 1041
适用范围:This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety, this International Standard gives requirements for intended performance, designattributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

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