C39 医用电子仪器设备 标准查询与下载
共找到 712 条与 医用电子仪器设备 相关的标准，共 48 页
Medical electrical equipment.Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); German version EN 60601-1:2006 + Cor. :2010 + A1:2013
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-12
- 实施
- 2013-12-01
Regulations for Supervision and Inspection of Installation of Medical Oxygen Chamber
- ICS
- 11.040
- CCS
- C39
- 发布
- 2013-11-05
- 实施
- 2014-01-01
Replace the existing first dashed item with: – "the general standard" designates IEC 60601-1 alone (IEC 60601-1-1:2005+A1:2012);Replace the existing second dashed item with:– "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)
Medical electrical equipment.Part 1-10: General requirements for basic safety and essential performance.Collateral Standard: Requirements for the development of physiologic closed-loop controllers; Amendment 1
- ICS
- 11.040
- CCS
- C39
- 发布
- 2013-11
- 实施
- 2013-11-29
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-11
- 实施
本标准对3.9定义的心电诊断设备(以下或简称设备)建立了最低的性能要求,该设备具有直接记录的装置。心电诊断设备的所有部分适用于本标准,它们应包括从人体表面获得心电信号、放大该信号和以一个适合于诊断心脏电活动的方式显示该信号。本标准对心电诊断设备从输入电极至输出显示规定了要求。第5章的裁定试验方法的目的是提供能明确地建立符合本标准的一些手段。这些试验方法不是用来核实单个设备的性能,无论是用于制造商的质量保证检查或是医院内的日常检查。此外,依据裁定试验方法的定义,允许使用其他的设计验证方法,只要那些等价方法能与那些裁定试验方法有可比性的试验结果。
Diagnostic electrocardiographic devices
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2013-10-21
- 实施
- 2014-10-01
1范围和目的除下述内容外,通用标准的本章适用。1.1范围增补:本专用标准规定了适用于2.101所定义的动态心电图系统的专用安全要求。以下类型的系统在本标准的范围内:a) 可连续记录和分析心电图的系统,并且该系统在对心电图进行完整的重新分析时能给出基本相同的结果。这个系统可以先记录和储存心电图,然后在一个独立的单元进行分析,或者记录和分析同时进行。本标准不涉及所用储存媒介的类型;b)能够提供连续分析和部分或有限的记录,但不能对心电图进行完整的重新分析的系统。满足上述任一类型的系统均适用于本标准的安全要求。如果动态心电图系统提供自动心电图分析,则适用本标准规定的测量和分析功能的最低性能要求。由GB 10793-2000和GB 9706.25-2005所覆盖的医用电气设备不在本标准的范围内。本标准不适用于不能对心电图进行连续记录和分析的系统(例如,“间歇事件记录仪”)。1.2目的替换:本专用标准的目的是为了制定对动态心电图系统安全和基本性能的专用要求。
Medical electrical equipment.Part 2:Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013-10-21
- 实施
- 2014-10-01
增补:本专用标准规定了2.1.101所定义的肌电图设备和2.1.102所定义的诱发反应设备,下文统称设备。替换:本专用标准的目的是建立在2.1.101所定义的肌电图设备和2.1.102所定义的诱发反应设备安全专用要求。
Medical electrical equipment.Part 2:Particular requirments for the safety of electromyograohs and evoked response equipment
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2013-10-21
- 实施
- 2014-10-01
Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-10
- 实施
- 2013-11-01
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
- ICS
- 11.040.20;11.040.55;11.040.99;11.140;29.140.40
- CCS
- C39
- 发布
- 2013-10
- 实施
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-06
- 实施
- 2013-07-12
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-06
- 实施
Medical electrical equipment - Part 2-22 : particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- ICS
- 11.040.55;11.040.60
- CCS
- C39
- 发布
- 2013-05-17
- 实施
- 2013-05-17
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C39
- 发布
- 2013-05
- 实施
Medical electrical equipment - Part 2-13 : particular requirements for basic safety and essential performance of an anaesthetic workstation
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2013-04-06
- 实施
- 2013-04-06
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55;35.240.80
- CCS
- C39
- 发布
- 2013-04
- 实施
- 2013-04-25
Replace the existing fourth paragraph with the following: The standard does not formulate specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.
Medical electrical equipment.Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013-04
- 实施
- 2013-04
Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
- ICS
- 11.180.15
- CCS
- C39
- 发布
- 2013-02-28
- 实施
- 2013-02-28
本型式评价大纲（以下简称大纲）适用于供医疗临床诊断的数字脑电图机及脑电地形图仪（以下简称数字脑电图机）的型式评价。
Program of Pattern Evaluation of Digital Electroencephalogram Mapping & Brain Activity Mapping
- ICS
- CCS
- C39
- 发布
- 2013-02-16
- 实施
- 2013-05-16
本型式评价大纲适用于数字心电图机的型式评价;不适用于模拟心电图机、矢量心电图机和其他特殊用途的专用心电图机的型式评价。
Program of Pattern Evaluation of Digital Electrocardiographs
- ICS
- CCS
- C39
- 发布
- 2013-02-16
- 实施
- 2013-05-16
本型式评价大纲适用于以下两种类型的动态（可移动）心电图机的型式评价； a)可连续记录、分析心电图并实现全程回放。可先记录、存储后由独立工作站回放分析或记录、分析同时进行。 b)可连续分析但仅部分记录，不提供全程回放。
Program of Pattern Evaluation of Ambulatory Electrocardiographs
- ICS
- CCS
- C39
- 发布
- 2013-02-16
- 实施
- 2013-05-16
