11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

T/GDMDMA 0006-2022 可移动式智能高压供氧系统

规格要求、工作条件、外观与结构、输出流量偏差、制氧机所产生气体的理化指标、气密性、出气口压力范围、最大氧产量及氧浓度、噪声、计时器、制氧机监控灯、断电报警、定时功能、连续工作时间、电气安全要求。

Mobile intelligent high pressure oxygen supply system

YY/T 1838-2022 一次性使用末梢采血器

Disposable peripheral blood collection device

ISO 23371:2022 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 cuffpressure indicators used to indicate the intracuffpressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomytubes. This document is also applicable to devices that combine intracuffpressure indication with a method of cuffinflation (such as asyringe or pump) . The device can also provide a method of automatically maintaining cuffinflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuffpressure 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 80601-2-84:2022 医用电气设备 第2-84部分：紧急医疗服务环境用呼吸机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 an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; intended to be operated by a healthcare professional operator; intended for use in the EMS environment; and intended for invasive or non-invasive ventilation. NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility. * An EMS ventilator is not considered to utilize a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator. NOTE 2 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 IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This document does not specify the requirements for the following: ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[3]. ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‐2‐13[4]. ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79[5] and ISO 80601-2-80[6] [1]. obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70[7]. operator-powered resuscitators, which are given in ISO 10651‐4[8]. gas-powered emergency resuscitators, which are given in ISO 10651‐5[9]. continuous positive airway pressure (CPAP) ME equipment . high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87[11]. high‐frequency oscillatory ventilators (HFOVs)[10], which are given in ISO 80601-2-87[11]. NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. cuirass or "iron‐lung" ventilators. [1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

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

ISO 23372:2022 麻醉和呼吸设备.空气夹带装置

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 ASTM F1949:2022 EMS 地面车辆医用氧气输送系统标准规范

This specification covers minimum requirements for primary medical oxygen delivery systems for EMS ground vehicles used in the following applications: (1) the transportation of the sick and injured to or from an appropriate medical facility while basic, advanced, or specialized life support services are being provided, (2) the delivery of interhospital critical transport care, (3) the delivery of nonemergency, medically required, transport services, and (4) the transportation and delivery of personnel and supplies essential for proper care of an emergent patient. This standard establishes criteria to be considered in the performance, specification, purchase, and acceptance testing of EMS ground vehicles. The oxygen delivery system may be either a gaseous oxygen (GOX) system, or a liquid oxygen (LOX) system. Design and installation of the oxygen delivery system shall meet the requirements specified for: (1) capacity, (2) components such as oxygen piping system, flow control device, oxygen outlet, shutoff device, and secondary oxygen outlet, and (3) oxygen compartment. The oxygen system shall conform to the specified performance requirements including: (1) delivery flowrate, (2) delivery pressure, (3) delivery temperature, (4) temperature conditions such as storage temperature, cold soak, and heat soak, (5) electromagnetic interference, and (6) structural integrity against vibration, acceleration load, and shock load (basic design and crash worthiness). Installation requirements for oxygen piping routing and mounting, as well as flaring and bending, are specified. Design, installation, and pressure test requirements for GOX and LOX systems are detailed.

Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles

GSO ISO 81060-2:2022 无创血压计 第2部分：间歇式自动测量型临床研究

This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

GSO ISO 80601-2-12:2022 医用电气设备 第2-12部分：重症监护呼吸机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 a ventilator in combination with its accessories, hereafter referred to as ME equipment: intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. intended to be operated by a healthcare professional operator; and intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 4 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 IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2]; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4]; ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5]; ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1]; obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9]; continuous positive airway pressure (CPAP) ME equipment; high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[63]; NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. oxygen therapy constant flow ME equipment; and cuirass or "iron-lung" ventilation equipment. [1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

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

BS EN ISO 10079-1:2022 医疗吸引设备 电动抽吸设备

What is ISO 10079-1 - Medical suction equipment - Electrically powered suction equipment about? ISO 10079-1 is an international standard that specifies safety and performance requirements for medical suction equipment that are common to all parts of the ISO 10079 series. ISO 10079-1 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. ISO 10079-1 applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients, and for field use and transport use. Who is ISO 10079-1 - Medical suction equipment - Electrically powered suction equipment for? ISO 10079-1 on <standard title> is useful for: Medical and surgical suction equipment manufacturers and suppliers Health care centres and hospitals Domiciliary care of patients Quality control personnel Safety regulatory bodies Why should you use ISO 10079-1 - Medical suction equipment - Electrically powered suction equipment ?

Medical suction equipment. Electrically powered suction equipment

ISO 80601-2-13:2022 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

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

EN ISO 10079-1:2022 医用抽吸设备.第1部分:电动抽吸设备

This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)

DB32/T 4227-2022 高流量呼吸湿化治疗仪临床使用安全管理与质量控制规范

本文件适用于各级各类医疗机构临床使用高流量呼吸湿化治疗仪的安全管理与质量控制。

Safety management and quality control specifications for clinical use of high-flow respiratory humidification therapy equipment

ISO 10079-3:2022 医用吸引设备第3部分:真空或正压气源驱动的吸引设备

This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.

Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source

ISO 10079-2:2022 医用吸引设备第2部分:手动吸引设备

This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.

Medical suction equipment — Part 2: Manually powered suction equipment

ISO 10079-1:2022 医用吸引设备第1部分:电动吸引设备

This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.

Medical suction equipment — Part 1: Electrically powered suction equipment

SN/T 5473.1-2022 出口医疗器械检验技术要求 第1部分：呼吸机

Technical Requirements for Inspection of Export Medical Devices Part 1: Ventilators

EN ISO 26825:2022 麻醉和呼吸设备.麻醉过程中使用含有麻醉药耳咽管的用户应用标签.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 (ISO 26825:2020)

ISO 4135:2022 麻醉学词汇

This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems. NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre- coordinated domain-specific term names. NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and French), this document gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.

Anaesthesiology — Vocabulary

YY 9706.274-2022 医用电气设备 第2-74部分：呼吸湿化设备的基本安全和基本性能专用要求

Medical electrical equipment Part 2-74: Specific requirements for basic safety and essential performance of respiratory humidification equipment

KS P ISO 80601-2-84:2021 医用电气设备第2-84部分:紧急医疗服务环境用呼吸机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