11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

ISO 80601-2-84:2023 医用电气设备第2-84部分:紧急医疗服务环境用呼吸机的基本安全和基本性能的特殊要求

Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

ISO 11712:2023 麻醉和呼吸设备 喉上气道和连接器

Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors

ISO 10524-1:2018/Amd 1:2023 医用气体用压力调节器 第 1 部分：压力调节器和带有流量计量装置的压力调节器 修正案 1

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices — Amendment 1

YY/T 0977-2023 麻醉和呼吸设备 口咽通气道

本文件规定了塑料和/或橡胶材料制成的口咽通气道（包括带有塑料和/或金属材料制成的加强插入物的口咽通气道）的要求。本文件未规定口咽通气道的易燃性要求。本文件不适用于金属口咽通气道以及无内部的、完整密封装置的上喉部通气道。

Anesthesia and Respiratory Equipment Oropharyngeal Airways

ISO/DIS 7396-3:2023 医用气体管道系统 第 3 部分：用于生产合成医用空气的配比装置

Medical gas pipeline systems — Part 3: Proportioning units for the production of synthetic medical air

ISO 15002:2023 用于连接到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

IEC 60601-2-21/AMD1:2023 PRV

23/30464123 DC BS ISO 18190 麻醉和呼吸设备 气道装置及相关设备的一般要求

BS ISO 18190 Anaesthetic and respiratory equipment. General requirements for airway devices and related equipment

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