BS EN 14136-2004 体外诊断检验程序的性能评定中外部质量评定方案的使用

百检网 2021-08-05
标准号:BS EN 14136-2004
中文标准名称:体外诊断检验程序的性能评定中外部质量评定方案的使用
英文标准名称:Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
标准类型:C05
发布日期:2004/5/26 12:00:00
实施日期:2004/5/26 12:00:00
中国标准分类号:C05
国际标准分类号:11.100.10
适用范围:This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: — scheme design and organisation; — identification of procedures (IVD MDs) used by the participant; — classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

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