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
本文件规定了多参数患者监护仪的基本安全和基本性能要求。本文件适用于预期连接到单一患者、具有两个或多个生理监护单元的多参数患者监护仪，其预期在专业医疗机构内使用，以及在紧急医疗服务环境或家庭护理环境内使用。本文件不适用于多参数患者监护仪的植入式部分。本文件未规定单独生理监护单元的要求，如心电图（ECG）、有创压和脉搏血氧，其要求在相关专用标准中以独立式医用电气设备的角度有所规定。
Medical electrical equipment Part 2-49: Specific requirements for basic safety and basic performance of multi-parameter patient monitors
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2023-01-13
- 实施
- 2026-01-15
本文件规定了医用磁共振成像设备的要求和试验方法。本文件适用于超导型磁共振成像设备、永磁型磁共振成像设备及常导型磁共振成像设备。
General technical conditions for medical magnetic resonance imaging equipment
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2023-01-13
- 实施
- 2026-01-15
Cardiac electrophysiological mapping system
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2022-05-18
- 实施
- 2023-06-01
This amendment updates references in clause 2 of this standard and modifies or amends terms in clause 3 of this standard.
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 (IEC 60601-1-10:2007 + A1:2013 + A2:2020); German vers
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2021-11-01
- 实施
- 2021-11-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs; Corrigendum 1
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-10-01
- 实施
The purpose of this second amendment to IEC 60601-1-3:2008 is to introduce changes to reference the second amendment (2020) to IEC 60601-1:2005.
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + A1:2013 + A2:2021); German version EN 60601-1-3:2008 +
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2021-10-00
- 实施
- 2021-10-01
Medical electrical equipment Part 2-47: Specific requirements for basic safety and basic performance of ambulatory electrocardiography systems
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Medical electrical equipment Part 2-21: Specific requirements for basic safety and basic performance of infant radiant warming tables
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Medical electrical equipment Part 2-34: Specific requirements for basic safety and basic performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-09-06
- 实施
- 2024-05-01
Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations
- ICS
- 11.140
- CCS
- C39
- 发布
- 2021-05-01
- 实施
Assisted surgical equipment and assisted surgical systems using robotic technology
- ICS
- 11.040
- CCS
- C39
- 发布
- 2021-03-09
- 实施
- 2022-10-01
Medical electrical equipment Part 2-20: Specific requirements for basic safety and essential performance of infant transport incubators
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 2-40: Special requirements for basic safety and basic performance of myoelectric and induced response equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment. Particular requirements for basic safety and essential performance of oxygen-conserving equipment
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2020-11-23
- 实施
- 2020-11-23
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente
Medical electrical equipment - Part 2-67 : particular requirements for basic safety and essential performance of oxygen-conserving equipment
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2020-11-18
- 实施
- 2020-12-25
Le présent document s'applique à la sécurité de base et aux performances essentielles des appareils à laser pour applications chirurgicales, thérapeutiques, de diagnostic médical, esthétiques ou vétérinaires destinés à être utilisés sur les personnes ou les animaux; ils sont clas
Medical electrical equipment - Part 2-22 : particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2020-10-30
- 实施
- 2021-01-02
multi-channel physiological recorder
- ICS
- 11.040.50
- CCS
- C39
- 发布
- 2018-12-20
- 实施
- 2020-01-01
本标准适用于山西省行政区域内心电信号J波分类判别。
Classification and Discrimination Method of J Wave of ECG Signal
- ICS
- 11.02
- CCS
- C39
- 发布
- 2018-07-20
- 实施
- 2018-09-20
This Standard specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor, intended for continuous operation for use with a patient. This Standard specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. This Standard is not applicable to a respiratory gas monitor intended for use with flammable anaesthetic agents. A respiratory gas monitor can be either standalone equipment or integrated into other equipment, e. g. an anaesthetic workstation or a ventilator.
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018); German version EN ISO 80601-2-55:2018
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2018-07-01
- 实施
- 2018-07-01
本标准规定了用于SPECT成像的CT衰减校正的试验方法。本标准适用于SPECT/CT一体机。本标准不适用于单机的SPECT系统
Test method for CT attenuation correction in SPECT imaging
- ICS
- CCS
- C39
- 发布
- 2018-04-01
- 实施
- 2018-04-01
