11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

GB 9706.255-2022 医用电气设备 第2-55部分：呼吸气体监护仪的基本安全和基本性能专用要求

在实验室研究应用中使用的RGM通常是实验性或主要预期用于非医疗用途。将本文件的要求强加于用于研究的RGM可能会过度限制有益的新技术或RGM设计的发展。防止全身麻醉状态下的非预期的清醒一直是一个棘手问题。通常情况下,当重新安置患者时将麻醉剂输送设备空载运行或有意关闭,并且无意中没有调回去,这时就会发生这些事件。RGM的数据和报警状态对于发现这些事件是有用的辅助方式。遗憾的是,这些信息通常不能通过电子接口获得。但是,智能分布式报警系统的发展可建立警告操作者这些情况的能力。RGM的数据对于创建一个完整且精准的电子医疗记录也是必要的。因此,鼓励RGM制造商为第三方通过开放的、基于标准的电子数据接口建立这样的数据访问。201.

Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

GB 9706.290-2022 医用电气设备 第2-90部分：高流量呼吸治疗设备的基本安全和基本性能专用要求

高流量呼吸治疗设备与专供依赖呼吸机患者使用的呼吸机之间存在关键的场景差异。其中一个不同之处在于患者是否具有保持肺部适当自主通气的能力,另一个不同之处在于机械通气与其他重要生社活方式功能(例如,饮食、言语、心理社会方面和一般身体活动)之间的平衡。在选择和配置模式、回路和版报警状态时,监管临床医生和患者需根据患者的临床需求、自主性和生活方式等因素,平衡机械通气的出认知和确定性。准对传统氧气疗法的替代疗法(即加热加湿高流量氧气疗法)的兴趣呈不断增加趋势。这种形式的呼标吸支持可通过各种气道器械来提供。这种支持通常会以高于传统氧气疗法中的输送流量,向患者提供国空气和氧气混合物,并且旨在尽可能降低室内空气的夹带量。临床医生通常将这种方法称为“高流量鼻中氧管疗法”“经鼻高流量疗法”“高流量氧气疗法”或“湿化高流量疗法”。在先前已对使用高流量呼吸治疗设备的几种生理效应进行过描述: ———咽喉死腔冲洗; ———鼻咽阻力降低; ———呼气正压效应; ———肺泡复张; ———提高湿度、舒适度和患者耐受性; ———更好地控制肺部氧浓度;和 ———黏膜纤毛清除。[]其他信息见ISO/TR2195417 。符合本文件的高流量呼吸治疗设备预期能为广泛范围的患者提供充分气体交换。其中可包括肺血管功能障碍患者,例如具有氧气依赖表现型的新冠病毒患者。据观察,通过鼻氧管提供高流量可产生咽部正压,呼气期间10 L/mi n流量通常可产生高达约1hPa 的正压。产生的压力不仅取决于流量,还取决于尖头与鼻孔的横截面积之比,以及嘴部是否闭合。高流量呼吸治疗设备通常由5 部分组成:1)气源连接: ———空气;和 ———氧气;注1:气源包括医用气体管道系统、气瓶、制氧机和环境空气。41 GB9706.290—2022

Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment

GB 9706.204-2022 医用电气设备 第2-4部分：心脏除颤器的基本安全和基本性能专用要求

本文件所规定的要求,是针对具备或不具备集成监视器的通常使用的除颤器,这就是,一个ME设备包含作为能量储存装置的电容。该电容被充电至高电压并且直接或者通过串联电感或电阻连接到输出电极。 本文件的第一版,对除颤器和除颤器-监护仪做了区分。这是由于同时并行拟定后者和除颤器规范草案,两者的规范在后期草案中合并。在本版本中,这样的区分不再必要并予以取消。 本文件没有提出对可植入除颤器的要求,因考虑到有太多差异所以区别对待。 本文件第一版发布后,自动体外除颤器(AEDs)已经广泛应用。为标准化这些设备,本文件中修改或提出了若干新的要求。各种治疗波形应用于去除心脏纤维性颤动,它包括正弦衰减波、双向波和指数截尾波。除颤器设计者、责任方和评估者宜当深入考虑。临床研究已证明,纤维性颤动去除功效随波形形状而变化较大,其他参数也类似,包括:电压幅度、释放能量、倾斜度和总持续时间。波形技术发展迅速。这些不包括在本文件特定安全性要求中。然而,由于功效对这些参数变化的敏感性,适当的临床确认宜考虑为必需的。特别宜注意给出对电流不足或持续时间延长的波形功效的确认,以及给出过大峰值电流波形的安全性确认。条款201.4.2.1.5 并列标准1.3 专用标准2 术语和定义201.

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

GB 9706.213-2021 医用电气设备 第2-13部分：麻醉工作站的基本安全和基本性能专用要求

本文件适用于需要专业操作者持续参与的.用于管理吸入麻醉的麻醉工作站的基本安全和基本性能。

Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation

GB 9706.212-2020 医用电气设备 第2-12部分：重症护理呼吸机的基本安全和基本性能专用要求

GB9706.1—2020 中1.1 由以下内容替换: ———本部分适用于与其附件组合使用的呼吸机的基本安全和基本性能,以下也称为ME设备:预期用于依赖机械通气的患者、且由专业操作者照管的;并且注1:这类呼吸机被认为是生命支持的ME设备或ME系统。 ———预期用于专业医疗场所的急救护理环境中,或预期用于专业医疗场所内的转运。 注2:在专业医疗场所内用于转运的重症护理呼吸机不认为是一种急救和转运用呼吸机。 本部分的各项规定亦适用于制造商预期用于连接至VBS或连接至呼吸机的附件,且该类附件的特性可能影响呼吸机的基本安全和基本性能。本部分不适用于不依赖机械通气的患者所使用的通气模式下运行的ME设备和ME系统。 注3:在上述模式下运行的重症不认为是生命支持ME设备或ME系统。 如果某章或某条明确指出仅适用于ME设备,或仅适用于ME系统,标题和章或条的正文会说明。如果未明确指出,则与此相关的章或条同时适用于ME设备和ME系统。除GB9706.1—2020 中7.2.

Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

GB 9706.8-2009 医用电气设备　第2-4部分:心脏除颤器安全专用要求

本专用标准规定了在2.1.101中定义的心脏除颤器的安全要求，本文此后称心脏除颤器为设备。 本专用标准不适用于植入式除颤器、遥控除颤器、体外经皮起搏器、分开单立的心脏监护仪(符合GB 9706.25)。使用分开的心电监护电极的心脏监护仪不在本标准适用范围内，除非其被作为自动体外除颤器(AED)心律识别检测或同步心电复律的心搏检测的唯一基准使用。

Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators

GB 9706.28-2006 医用电气设备 第2部分; 呼吸机安全专用要求 治疗呼吸机

增加： 本专用标准适用于治疗呼吸机（见2.1.125的定义）的安全 本专用标准不适用于： 持续气道正压(CPAP)设备、睡眠呼吸暂停治疗设备、加强呼吸机、麻醉呼吸机、急救呼吸机、高频喷射呼吸机和高频振荡呼吸机，也不包括医院中使用的仅用作增加患者通气量的设备。

Medical electrical equipment.Part 2:Particular requirements for the safety of lung ventilators.Critical care ventilators

GB 9706.29-2006 医用电气设备.第2部分;麻醉系统的安全和基本性能专用要求

增加： 本专用标准规定了麻醉系统（见2.101.7的定义）和设计用于麻醉系统的单个装置的安全和基本性能的要求。 本专用标准不适用于： ——使用易燃麻醉剂的麻醉系统，如附录DD确定的； ——在偏远地区、露天区域用于急救手术的或在灾区使用的便携式麻醉系统； ——牙科止痛设备。

Medical electrical equipment.Part 2:Particular requirements for the safety and essential performance of anaesthetic systems

GB/T 4999-2003 麻醉呼吸设备 术语

本标准规定了麻醉呼吸设备以及供气、相关仪表和供应系统的名词术语。

Anaesthetic and respiratory equipment vocabulary

GB 11246-1989 人用持续气流吸入式麻醉机技术要求

本标准规定了人用持续气流吸入式麻醉机（以下简称为麻醉机）的技术要求。 本标准适用于人用持续气流吸入式麻醉机。 本标准不适用于按需流或间歇流麻醉机。

Specifications for continuous flow inhalational anaesthetic machines for use with humans

BS EN ISO 16571:2024 用于排出医疗设备产生的羽流的系统

Systems for evacuation of plume generated by medical devices

GSO ISO 80601-2-90:2024 医用电气设备 第2-90部分：呼吸高流量治疗设备基本安全和基本性能的特殊要求

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: —   intended for use with patients who can breathe spontaneously; and —   intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1        In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: —   fully integrated ME equipment; or —   a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2  This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4         Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. 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 the general standard, 7.2.13 and 8.4.1. NOTE 3        Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: —    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12[14]; —    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[15]; —    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[20]; —    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[17]; —    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[18]; —    ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[19]; —    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16]; —    continuous positive airway pressure (CPAP) ME equipment; —    high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601‑2‑87[21]; —    gas mixers for medical use, which are given in ISO 11195[9]; —    flowmeters, which are given in ISO 15002[11]; —    high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[21]; and —    cuirass or “iron-lung” ventilation equipment. This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.

Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

GSO ISO 23371:2024 麻醉和呼吸设备 袖带压力指示、控制和调节装置

This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.

Anaesthetic and respiratory equipment — Cuff pressure indication, control and regulation devices

GSO ISO 26825:2024 麻醉和呼吸设备 麻醉期间所用药物注射器的用户应用标签 颜色、设计和性能

This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name. NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.

Anaesthetic and respiratory equipment — User-applied labels for syringes containing drugs used during anaesthesia — Colours, design and performance

GSO ISO 23368:2024 麻醉和呼吸设备 用于氧气治疗的低流量鼻插管

This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.

Anaesthetic and respiratory equipment — Low-flow nasal cannulae for oxygen therapy

GSO ISO 80601-2-13:2024 医用电气设备 第2-13部分：麻醉工作站基本安全和基本性能的特殊要求

This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system (AGSS); anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. NOTE 1        Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1. An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard. NOTE 2        The applicability of this document is indicated in Table AA.2. This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 3        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

GSO ISO 23372:2024 麻醉和呼吸设备 空气引流装置

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).

Anaesthetic and respiratory equipment — Air entrainment devices

GSO ISO 80601-2-69:2024 医用电气设备 第2-69部分：氧气浓缩器设备基本安全和基本性能的特殊要求

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. 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 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.

Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

BS EN ISO 15002:2024 用于连接医用气体供应系统的流量控制装置

Flow control devices for connection to a medical gas supply system

24/30490695 DC BS EN IEC 60601-2-4:2011/A2 修改件2 医疗电气设备 第2-4部分：心脏除颤器基本安全和基本性能的特殊要求

BS EN IEC 60601-2-4:2011/A2 Amendment 2 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators