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
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（以下简称大纲）适用于医疗诊断的模拟脑电图机的型式评价。
Program of Pattern Evaluation of Electroencephalographs
- 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
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009); German version EN ISO 80601-2-56:2012
- ICS
- 17.200.20
- CCS
- C39
- 发布
- 2013-02
- 实施
- 2013-02-01
Health informatics. Personal health device communication. Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- ICS
- 35.240.80
- CCS
- C39
- 发布
- 2013-01-31
- 实施
- 2013-01-31
本标准规定了3.1定义的动态心电图系统的安全和性能要求。本标准适用于以下两种类型的动态心电图系统（以下简称“设备”）：a) 提供连续记录、分析心电图并实现全程回放。可先记录、存储心电图后再由独立装置回放分析或记录和分析同时进行。存储媒介的选用与本标准无关；b) 提供连续分析但仅部分记录，不提供全程回放。本标准不适用于不能提供连续记录和分析心电图的设备，如间断性事件记录器。
Dynamic ECG system
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013/01/15
- 实施
- 2013/01/15
Amendment 1 to Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013-01-01
- 实施
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2013-01-01
- 实施
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
- ICS
- 11.040.40
- CCS
- C39
- 发布
- 2013-01-01
- 实施
ECG trunk cables and patient leadwires
- ICS
- 11.040.10;29.060.10
- CCS
- C39
- 发布
- 2013-01-01
- 实施
Medical electrical equipment. Part 2-27. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2013
- 实施
- 2015-01-01
Medical electrical equipment. Medical electron accelerators. Functional performance characteristics
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2013
- 实施
- 2015-01-01
Health Informatics - Personal health device communication - Part 10441: Device specialization - Cardiovascular fitness and activity monitor
- ICS
- 35.240.80
- CCS
- C39
- 发布
- 2013
- 实施
이 표준은 최대 출력 1 kV/50 A 이하의 이식용 제세동기 전원에 이식 가능한 제세동기
Cardiac defibrillators－Connector assembly DF-1 for implantable defibrillators－Dimensions and test requirements
- ICS
- 11.040.40
- CCS
- C39
- 发布
- 2012-12-27
- 实施
- 2012-12-27
本规范规定了便携式血糖分析仪的计量特性、校准条件和校准方法。本规范用于体外监测人体血糖含量的便携式血糖分析仪。
Calibration Specification for Portable Blood Glucose Meters
- ICS
- CCS
- C39
- 发布
- 2012-12-21
- 实施
- 2013-03-21
이 표준은 환자의 치료를 위하여 이용되는 1∼50 MeV 범위의 전자 가속기의 기본 안전과
Medical Electrical Equipment-Part 2-1:Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
- ICS
- 11.040.60
- CCS
- C39
- 发布
- 2012-12-20
- 实施
- 2012-12-20
이 부가표준은 의료용 전기기기와 시스템의 기본 안전 및 필수 성능에 대하여 규정하며, 의료
Medical electrical equipment－Part 1-2：General requirements for basic safety and essential performance－Collateral standard： Electromagnetic compatibility－Requirements and tests
- ICS
- 11.040.01;33.100.10;33.100.20
- CCS
- C39
- 发布
- 2012-12-20
- 实施
- 2012-12-20
이 표준은 인체를 대상으로 하는 의료적 치료를 목적으로 이용되는 의료용 전자가속기에 적용되
Medical electrical equipment－Medical electron accelerators－Guidelines for functional performance characteristics
- ICS
- 11.040.60
- CCS
- C39
- 发布
- 2012-12-20
- 实施
- 2012-12-20
KS C IEC 60601-1의 1.1에 따르는 외에 다음 사항을 추가한다.이 개별
Medical electrical equipment－Part 2-8：Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2012-12-20
- 实施
- 2012-12-20
Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of the IEC 60601-1:2005 to the previous edition
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2012-12
- 实施
