11.040.10 麻醉、呼吸和复苏设备 标准查询与下载
共找到 2037 条与 麻醉、呼吸和复苏设备 相关的标准，共 136 页
本文件规定了脉搏血氧设备的基本安全和基本性能。本文件适用于人体使用的脉搏血氧设备和已再加工的脉搏血氧设备。脉搏血氧设备包括脉搏血氧监护仪，脉搏血氧探头和探头的电缆延长线。本文件适用但不限于预期在专业医疗机构，家庭护理环境和紧急医疗服务环境中估计患者的动脉血氧饱和度和脉率的脉搏血氧设备。本文件也适用于疾病、损伤或者残疾的代偿或缓解的脉搏血氧设备，以及预期在院外或者医师办公室外的极端环境或者不受控环境下使用脉搏血氧设备，例如：救护车和航空转运，补充标准适用于在这些环境下使用的脉搏血氧设备。本文件不适用于实验室研究使用的脉搏血氧设备，也不适用于需采集患者血液样本的血氧仪。本文件不适用于胎儿专用脉搏血氧设备。本文件不适用于放置于患者环境之外显示SpO2数值的远程或从（次级）设备。
Medical electrical equipment Part 2-61: Specific requirements for basic safety and basic performance of pulse oximetry equipment
- ICS
- 11.040.10
- CCS
- C39
- 发布
- 2023-01-13
- 实施
- 2026-01-15
This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document. NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, — an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or — invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2023-01-11
- 实施
- 2023-04-30
BS EN ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3. Tests for emissions of volatile organic substances
- ICS
- 11.040.10
- CCS
- 发布
- 2023-01-09
- 实施
- 2023-01-09
Medical suction equipment — Part 1: Electrically powered suction equipment
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 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
- 发布
- 2022-12-28
- 实施
Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Medical electrical equipment ─ Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Medical electrical equipment ─ Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Anaesthetic and respiratory equipment ─ Tracheal tubes and connectors
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
Medical electrical equipment ─ Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-28
- 实施
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTE There is guidance or rationale for this list item contained in A.2.
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-21
- 实施
- 2023-03-31
Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-16
- 实施
BS EN ISO 18562-2. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2. Tests for emissions of particulate matter
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-02
- 实施
- 2022-12-02
BS EN ISO 18562-4. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4. Tests for leachables in condensate
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-02
- 实施
- 2022-12-02
BS EN ISO 18562-1. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1. Evaluation and testing within a risk management process
- ICS
- 11.040.10
- CCS
- 发布
- 2022-12-02
- 实施
- 2022-12-02
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
- ICS
- 11.040.10
- CCS
- 发布
- 2022-10-19
- 实施
- 2023-01-31
