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
本规范适用于手动心脏除颤器和自动体外除颤器(AED)与除颤功能直接相关的计量特性的校准;不适用于植入式除颤器、遥控除颤器的校准。
Calibration Specification for Cardiac Defibrillators
- ICS
- CCS
- C39
- 发布
- 2014-08-01
- 实施
- 2015-02-01
Medical electrical equipment. Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2014-07-31
- 实施
- 2014-07-31
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2014-07
- 实施
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1, Corrigendum 1
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2014-07
- 实施
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); German version EN 60601-1-3:2008 + Cor.:2010
- ICS
- 11.040.50;13.280
- CCS
- C39
- 发布
- 2014-06-01
- 实施
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2014-06
- 实施
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
- 2014-06
- 实施
UL Standard for Safety Hospital Signaling and Nurse Call Equipment: Section / Paragraph Reference: Subject: Frequency hopping and spread spectrum type (FHSS) wireless signaling technologies (Edition 7: October 12, 2007)
- ICS
- CCS
- C39
- 发布
- 2014-05-20
- 实施
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013); German version EN 60601-1-9:2008 + A1:2013
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2014-05
- 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 (IEC
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2014-04
- 实施
- 2014-04-01
Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES@ hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment@ such as@ but not limited to@ the generator of the PRESSURE PULSE@ PATIENT support device@ and their interactions with imaging and monitoring devices. Other devices@ such as PATIENT treatment planning computers@ X-ray and ultrasonic devices@ are excluded from this standard@ because they are treated in other applicable IEC standards. This particular standard does not apply to: ?C ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy; ?C ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
- ICS
- 11.040.01;11.040.60
- CCS
- C39
- 发布
- 2014-04
- 实施
- 2014-04-12
Health informatics. Point-of-care medical device communication. Nomenclature. Annotated ECG
- ICS
- 35.240.80
- CCS
- C39
- 发布
- 2014-03-31
- 实施
- 2014-03-31
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (Amendment 1)
- ICS
- 11.040
- CCS
- C39
- 发布
- 2014-03-01
- 实施
Medical electrical equipment -- Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
- ICS
- 11.040.20
- CCS
- C39
- 发布
- 2014-03-01
- 实施
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; Corrigendum 1
- ICS
- 11.040.30
- CCS
- C39
- 发布
- 2014-02
- 实施
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- ICS
- 11.040.01;33.100.10;33.100.20
- CCS
- C39
- 发布
- 2014-02
- 实施
- 2014-02-27
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; Supplement 1: High frequency surgical equipment - Operation and maint
- ICS
- 11.040.30
- CCS
- C39
- 发布
- 2014-02
- 实施
Medical devices - Application of usability engineering to medical devices
- ICS
- 11.040.01
- CCS
- C39
- 发布
- 2014-01
- 实施
- 2014-02-01
이 표준은 시약, 보정 물질, 표준 물질, 희석액, 완충액과 시약 키트를 포함하는 소위 체외 진단 시약이라 불리는 체외 진단 의료기기의 안정성 평가에 적용 가능하다. 이 표준은 샘플을 보존하거나 또는 샘플의 추가적인 처리를 위한 반응의 시작에 사용되는 물질을 포함하는 시료 수집 장비에 적용이가능하다.이 표준은 안정성 평가를 위한 일반적 요구사항을 규정하며 다음과 같은 경우에서 자료를 생성할 때실시간 및 가속화된 안정성 평가를 위한 특별 요구사항을 부여한다.― 제품사양 유지를 보장하는 데 적합한 운송 조건을 포함하는 체외 진단 시약 유효기간 확립― 1차 용기 개봉 후 체외 진단 시약 안정성 확립보기 운송 중 안정성, 제품 재구성 후 안정성, 개봉 후 시약용기의 안정성― 이미 시장에 비치된 체외 진단 시약의 안정성 모니터링― 안정성에 영향을 줄 수 있는 체외 진단 시약의 변형 후 안정성 규격서 검증이 표준은 장비, 기구, 기기, 시스템 또는 시료 용기나 시험용 샘플에 적용할 수 없다.
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.020
- CCS
- C39
- 发布
- 2013-12-30
- 实施
- 2013/12/30
이 표준은 체외 진단 검사 분야에서 매질효과의 유무를 평가하는 방법에 대하여 규정한다.이 표준은 표준물질, 교정자, 대조자 및 외부정도관리 평가물질 등을 대상으로 매질효과의 평가 방법에 대하여 규정한다.진단제품 제조자, 외부정도관리시험 제공자 및 인허가기관 등에서 이 표준을 사용할 수 있다.
Protocol for evaluation of matrix effects in in-vitro diagnostic test
- ICS
- 11.020;11.100
- CCS
- C39
- 发布
- 2013-12-30
- 实施
- 2013/12/30
