11.040.10 麻醉、呼吸和复苏设备 标准查询与下载

YY 9706.272-2021 医用电气设备 第2-72部分：依赖呼吸机患者使用的家用呼吸机的基本安全和基本性能专用要求

Medical electrical equipment Part 2-72: Specific requirements for basic safety and essential performance of household ventilators for use by ventilator-dependent patients

YY 0671-2021 医疗器械 睡眠呼吸暂停治疗 面罩和应用附件

Medical device sleep apnea treatment masks and application accessories

YY/T 1804-2021 麻醉和呼吸设备 用于测量人体时间用力呼气量的肺量计

Anesthesia and Respiratory Equipment Spirometer for measuring human time forced expiratory volume

OENORM EN ISO 80601-2-12:2021 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（ISO/DIS 80601-2-12:2021）

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/DIS 80601-2-12:2021)

OVE EN IEC 60601-2-20:2021 医用电气设备 第2-20部分：婴儿转运保育箱基本安全和基本性能的特殊要求（德文版）

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (german version)

DIN EN 60601-2-4:2021 医用电气设备 第 2-4 部分：心脏除颤器基本安全和基本性能的特殊要求（IEC 60601-2-4:2010 + A1:2018）；德文版 EN 60601-2-4:2011 + A1:2019

This International Standard applies to the basic safety and essential performance of cardiac defibrillators, hereafter referred to as me equipment. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and conten

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010 + A1:2018); German version EN 60601-2-4:2011 + A1:2019

DIN EN ISO 407:2021 小型医用气瓶 Pin-index 轭式阀门连接（ISO 407:2021）；德文版 EN ISO 407:2021

This International Standard concerns pin-index yoke-type valve connections for small medical gas cylinders.

Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021); German version EN ISO 407:2021

BS EN ISO 10651-5:2021 医用肺呼吸机 基本安全和基本性能的特殊要求 燃气动力紧急复苏器

1   * Scope This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders . This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use . This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22). This part of ISO 10651 is not applicable to electrically-powered resuscitators . NOTE ISO 10651‑3 covers emergency and transport ventilators.

Lung ventilators for medical use. Particular requirements for basic safety and essential performance - Gas-powered emergency resuscitators

LST EN ISO 407:2021 小型医用气瓶 Pin-index 轭式阀门连接（ISO 407:2021）

Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021)

BS ISO 21917:2021 麻醉和呼吸设备 语音假体

Anaesthetic and respiratory equipment. Voice prostheses

DS/ISO 21917:2021 麻醉和呼吸设备 发声假肢

Anaesthetic and respiratory equipment – Voice prostheses

BS EN IEC 60601-2-21:2021 医疗电气设备 婴儿辐射取暖器基本安全和基本性能的特殊要求

Medical electrical equipment. Particular requirements for the basic safety and essential performance of infant radiant warmers

DS/EN ISO 10651-5:2021 医用肺呼吸机《基本安全和基本性能的特殊要求》第5部分：气动急救器（ISO 10651-5:2006）

Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)

UNI EN ISO 80601-2-70:2021 医用电气设备 第 2-70 部分：睡眠呼吸暂停治疗设备基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

UNI EN ISO 80601-2-67:2021 医用电气设备 第 2-67 部分：氧气保存设备基本安全和基本性能的特殊要求

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

EN ISO 10651-5:2021 医用肺通气机.基本安全和性能的特殊要求.第5部分:气体驱动急救人工呼吸器

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)

ISO 80601-2-90:2021 医用电气设备.第2-90部分：呼吸高流量治疗设备的基本安全和基本性能的特殊要求

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

ISO 21917:2021 麻醉和呼吸设备.语音假体

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 10079-4:2021 医疗抽引设备. 第3部分: 一般要求

This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) dental suction equipment; e) laboratory suction; b) syringes; d) anaesthetic gas scavenging systems; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) j) ventouse (obstetric) equipment; suction equipment marked for endoscopic use only; and k) plume evacuation systems.

Medical suction equipment - Part 4: General requirements

prEN ISO 80601-2-12:2021 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（ISO/DIS 80601-2-12:2021）

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO/DIS 80601-2-12:2021)