标准号: |
ISO 18113-1-2009 |
英文名称: |
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements |
中标分类: |
医药卫生劳动保护>>医疗器械综合 |
发布日期: |
2009-12 |
发布单位: |
IX-ISO |
标准状态: |
请与本站工作人员进行确认 |
ICS分类: |
0>>0 |
起草单位/标准公告: |
ISO/TC 212 |
正文语言: |
英语 |
页数: |
49P;A4 |
被代替标准: |
ISO/FDIS 18113-1-2009 |
引用标准: |
EN 980-2008;IEC 62366-2007;ISO 1000-1992;ISO 13485-2003;ISO 14971-2007;ISO 15223-1-2007 |
采用关系: |
DIN EN ISO 18113-1-2010,IDT;DIN EN ISO 18113-1-2013,IDT;BS EN ISO 18113-1-2010,IDT;BS EN ISO 18113-1-2011,IDT;GB/T 29791.1-2013,IDT;EN ISO 18113-1-2009,IDT;EN ISO 18113-1-2011,IDT;NF S92-010-1-2010,IDT;NF S92-010-1-2012,IDT;S92-010-1PR,IDT;SN EN ISO 18113-1-2010,IDT;SN EN ISO 18113-1-2012,IDT;OENORM EN ISO 18113-1-2010,IDT;OENORM EN ISO 18113-1-2012,IDT;PN-EN ISO 18113-1-2010,IDT;PN-EN ISO 18113-1-2011,IDT;PN-EN ISO 18113-1-2013,IDT;SS-EN ISO 18113-1-2009,IDT;SS-EN ISO 18113-1-2011,IDT;UNE-EN ISO 18113-1-2010,IDT;UNE-EN ISO 18113-1-2012,IDT;KS P ISO 18113-1-2012,IDT;GOST R ISO 18113-1-2015,IDT;TS EN ISO 18113-1-2014,IDT;DS/EN ISO 18113-1-2010,IDT;DS/EN ISO 18113-1-2012,IDT;UNI EN ISO 18113-1-2010-2010,IDT;UNI EN ISO 18113-1-2012-2012,IDT;STN EN ISO 18113-1-2010,IDT;STN EN ISO 18113-1-2012,IDT;CSN EN ISO 18113-1-2010,IDT;CSN EN ISO 18113-1-2012,IDT;DS/EN ISO 18113-1-2010,IDT;DS/EN ISO 18113-1-2012,IDT;NEN-EN-ISO 18113-1-2010 en-2010,IDT;NEN-EN-ISO 18113-1-2011 en-2011,IDT |
内容提要(CN): |
分析装置;应用;制造日期;定义;诊断(医学);诊断设备;诊断系统;企业;在体外;信息;使用说明;研究;实验室条件下诊断;加标签;实验室医学;医疗设备;医学科学;医疗技术学;操作说明书;自测;规范(验收);术语;用户信息 |
内容提要(EN): |
Apparatus for analysis;Applications;Data of the manufacturer;Definitions;Diagnosis (medical);Diagnostic equipment;Diagnostic systems;Enterprises;Experts;In vitro;Information;Instructions for use;Investigations;In-vitro diagnostic;Labelling;Laboratory medicine;Medical equipment;Medical sciences;Medical technology;Operational instructions;Self-testing;Specification (approval);Terminology;User information |
归属: |
国际 |
|