ISO/TS 25238-2007 健康信息学.健康软件防范风险分类

百检网 2021-08-04
标准号:ISO/TS 25238-2007
中文标准名称:健康信息学.健康软件防范风险分类
英文标准名称:Health informatics - Classification of safety risks from health software
标准类型:C07
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C07
国际标准分类号:35.240.80
适用范围:This Technical Specification is concerned with the safety of patients and gives guidance on the analysis andcategorization of hazards and risks to patients from health software products, in order to allow any product tobe assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient.Other risks, such as financial or organizational risks, are outside the scope of this Technical Specificationunless they have the potential to harm a patient.This Technical Specification applies to any health software product, whether or not it is placed on the marketand whether it is for sale or free of charge. Examples of the application of the classification scheme are given.This Technical Specification does not apply to any software which is necessary for the proper application orfunctioning of a medical device.NOTE This Technical Specification is intended for the assignment of health software to broad risk classes, so as toaid decisions such as what controls should be applied to ensure safety. It is not intended for the application of risk analysisand risk management to the design of health software products and the mitigation of any identified risks to acceptablelevels (see Annex A).

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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