11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

23/30475032 DC BS EN ISO 80601-2-74 医疗电气设备 第2-74部分 呼吸湿化设备基本安全和基本性能的特殊要求

BS EN ISO 80601-2-74. Medical electrical equipment - Part 2-74. Particular requirements for basic safety and essential performance of respiratory humidifying equipment

T/ZPP 043-2023 一次性使用封堵支气管插管

本文件规定了一次性使用封堵支气管插管的术语和定义、产品结构、技术要求、试验方法、检验规则、标志、包装、运输和贮存技术要求。 本文件适用于一次性使用封堵支气管插管生产和检验。

Disposable blocked bronchial intubation

T/GDAQI 110-2023 气管插管内径测试方法

本文件规定了气管插管内径测试的原理、仪器设备、试验要求、试验步骤及试验报告。 本文件适用于常用型气管插管及柯尔（Cole)型插管内径的测试。

Test method for inner diameter of tracheal tubes

ISO 27427:2023 麻醉和呼吸设备 雾化系统和组件

Anaesthetic and respiratory equipment — Nebulizing systems and components

ISO 5367:2023 麻醉和呼吸设备 呼吸装置和连接器

Anaesthetic and respiratory equipment — Breathing sets and connectors

CSA C22.2 No.80601-2-13-2023 医用电气设备 第2-13部分：麻醉工作站的特殊基本安全和基本性能要求

Domaine d’application [Ajouter le paragraphe suivant] Cette norme s’applique aux APPAREILS EM et SYSTEMES EM destinés à être installés ou utilisés conformément à CSA C22.1, Code canadien de l’électricité, Première partie.

Appareils électromédicaux — Partie 2-13 : Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d’anesthésie

ISO 80601-2-72:2023 医用电气设备 第2-72部分：呼吸机依赖患者家庭医疗环境呼吸机基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

23/30441461 DC BS EN ISO 80601-2-79 医疗电气设备 第 2-79 部分 通气障碍用通气支持设备基本安全和基本性能的特殊要求

BS EN ISO 80601-2-79. Medical electrical equipment - Part 2-79. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

23/30441465 DC BS EN ISO 80601-2-80 医疗电气设备 第 2-80 部分 通气功能不全的通气支持设备基本安全和基本性能的特殊要求

BS EN ISO 80601-2-80. Medical electrical equipment - Part 2-80. Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

GSO ISO 80601-2-85:2023 医用电气设备 第2-85部分：脑组织血氧计设备基本安全和基本性能的特殊要求

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use. NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature. Not included within the scope of this document are: invasive tissue or vascular oximeters; oximeters that require a blood sample from the patient; equipment measuring dissolved oxygen; ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4]; ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601‑2‑61[3]; ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head. This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard. NOTE 2 See also 4.2 of the general standard. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury or disability. This document is not applicable to remote or slave (secondary) equipment that displays StO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.

Medical electrical equipment — Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

GSO ISO/TS 81060-5:2023 无创血压计 第5部分：自动无创血压计测试用 NIBP 模拟器的重复性和再现性要求

This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only. In addition, the pulse rate set on the NIBP simulator is tested. This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties). NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups. This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers. NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols. This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.

Non-invasive sphygmomanometers — Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers

GSO ISO 9360-2:2023 麻醉和呼吸设备 用于加湿人体呼吸气体的热湿交换器（HME） 第2部分：用于最小潮气量为250毫升的气管切开患者的HME

  Scope is not provided for this standard

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml

BS EN ISO 10651-4:2023 肺呼吸机 用户供电复苏器的特殊要求

1   Scope This document specifies requirements for user -powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User -powered resuscitators are designated according to ideal body mass range. Example user -powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user ’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user ’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories

Lung ventilators - Particular requirements for user-powered resuscitators

EN ISO 10651-4:2023 肺部呼吸器.第4部分:操作员控制的人工呼吸器的特殊要求

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)

YY 9706.279-2023 医用电气设备 第2-79部分：用于呼吸功能障碍的呼吸支持设备的基本安全和基本性能专用要求

本文件规定了与附件组合使用的用于呼吸功能障碍的呼吸支持设备的基本安全和基本性能。本文件适用于预期在家庭护理环境下由无经验的操作者操作，用于患有呼吸功能障碍的患者的呼吸支持设备。本文件也适用于制造商预期连接至呼吸功能障碍的呼吸支持设备的呼吸系统的附件，这些附件的特性可能影响呼吸功能障碍的呼吸支持设备的基本安全和基本性能。本文件不适用于实时依赖于人工通气进行生命支持的患者的设备、重症监护呼吸机及其附件、麻醉呼吸机及其附件、急救与转运呼吸机及其附件、依赖呼吸机患者使用的家用呼吸机、用于呼吸功能不全的呼吸支持设备、阻塞性睡眠呼吸暂停症治疗用医用电气设备、持续气道正压医用电气设备、高频喷射呼吸机、高频振荡呼吸机、恒流氧疗设备、铁甲与“铁肺”呼吸机。

Medical electrical equipment Part 2-79: Specific requirements for basic safety and essential performance of respiratory support equipment for respiratory dysfunction

YY 0499-2023 麻醉和呼吸设备 气管插管用喉镜

本文件规定了具有非软性窥视片的喉镜的要求以及带有可互换钩紧连接件的手柄和喉镜窥视片的关键尺寸。本文件适用于具有内部电池供电的电源、用于在插管过程中照亮喉部的喉镜。本文件不适用于以下产品：软性喉镜，为手术设计的喉镜，由网电源供电的喉镜，通过光缆连接到外部光源的喉镜，设计用于外部、一体化或附加视频系统连接工作的视频喉镜。

Anesthesia and respiratory equipment Laryngoscope for tracheal intubation

YY 9706.280-2023 医用电气设备 第2-80部分：用于呼吸功能不全的呼吸支持设备的基本安全和基本性能专用要求

本文件规定了与附件组合使用的用于呼吸功能不全的呼吸支持设备的基本安全和基本性能。本文件适用于预期在家庭护理环境下由无经验的操作者操作，用于患有呼吸功能不全或衰竭的患者预期转移时可运行的呼吸支持设备。本文件也适用于制造商预期连接至呼吸功能不全的呼吸支持设备的呼吸系统的附件，这些附件的特性可能影响呼吸功能不全的呼吸支持设备的基本安全和基本性能。本文件不适用于预期用于实时依赖于人工通气进行生命支持的患者的设备。本文件不适用于重症监护呼吸机及其附件、麻醉呼吸机及其附件、急救与转运呼吸机及其附件、依赖呼吸机患者使用的家用呼吸机、呼吸功能障碍的呼吸支持设备、阻塞性睡眠呼吸暂停症治疗用医用电气设备、持续气道正压医用电气设备、高频喷射呼吸机、高频振荡呼吸机、恒流氧疗设备、铁甲与“铁肺”呼吸机。

Medical electrical equipment Part 2-80: Specific requirements for basic safety and essential performance of respiratory support equipment for respiratory insufficiency

YY/T 0893-2023 医用气体混合器 独立气体混合器

本文件规定了预期用于将氧气与另一种医用气体混合的独立气体混合器的性能和安全要求。本文件不适用于每种气体流量独立控制的流量计组，混合氧气和周围空气的独立气体混合器，具有两个以上不同气体进气口的独立气体混合器，与氧气浓缩器相连的独立气体混合器。

Medical gas mixer stand-alone gas mixer

ISO 10651-4:2023 医用肺通气机.第4部分:操作员控制的呼吸器的特殊要求

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

Lung ventilators — Part 4: Particular requirements for user-powered resuscitators

23/30466300 DC BS ISO 17256 麻醉和呼吸设备 呼吸治疗管和连接器

BS ISO 17256. Anaesthetic and respiratory equipment. Respiratory therapy tubing and connectors