睡眠呼吸窒息治疗设备检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY 0600.1-2007医用呼吸机基本安全和主要性能专用要求第1部分：家用呼吸支持设备

除下述部分外，GB 9706.1-2007第1章适用修改：YY 0600的本部分规定了家用呼吸支持设备的基本安全和主要性能的要求，该设备适用于不必使用符合YY 0600.2家用呼吸机的患者，主要用在家庭护理也可用在其他地方（如医疗保健部门）若YY 0600的本部分的要求取代或修改了通用标准要求的部分，则该要求优先于相应的通用要求。

YY 0671.2-2011睡眠呼吸暂停治疗.第2部分：面罩和应用附件

YY 0671的本部分适用于面罩及其固定和用来连接睡眠呼吸暂停治疗设备到患者的附件。它详细地规定了对于面罩和附件的要求，涵盖了用于任何必要连接的部件，这些部件既包括睡眠呼吸暂停治疗设备的患者接口和患者连接时需要的部分，也包括睡眠呼吸暂停治疗过程中使用的部分，诸如鼻罩、排气口和头带。对睡眠呼吸暂停治疗设备的要求见YY 0671的第1部分。对YY 0671标准的两部分涉及的典型部件参见图A.1。本部分不包括对口腔矫治器的要求。

EN ISO 17510-1-2009睡眠窒息呼吸治疗.第1部分:睡眠窒息呼吸治疗设备

Amendment (add at the end of the Subclause 1.1):This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy fordomiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.This part of ISO 17510 applies to equipment intended for use with adults and children, and excludesequipment intended for use with neonates.Jet and very high frequency ventilation and oscillation are not considered in This part of ISO 17510.This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:? ISO 10651-2:2004;? ISO 10651-3:1997;? ISO 10651-4:2002;? ISO 10651-5:2006;? ISO 10651-6:2004.This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masksand accessories used to connect sleep apnoea breathing therapy equipment to the patient. See alsoFigure AA.1.

NF S95-186-2-70-2020医疗电气设备. 第2-70部分: 睡眠窒息呼吸治疗设备基本安全和基本性能的特殊要求

Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements de thérapie respiratoire pour l'année du sommeil, désignés ci-après sous le terme d'appareils EM, destinés à soulager les symptômes des patients souffrant d'apnée obstructive du sommeil en délivrant une pression respiratoire à visée thérapeutique dans les voies respiratoires du patient. L'équipement de thérapie respiratoire pour l'apnée du sommeil est destiné à être utilisé dans un environnement de soins à domicile par des opérateurs non spécialistes ainsi que dans des établissements de soins de santé professionnels.

DIN EN ISO 11073-10424-2016健康信息学. 个人保健装置通信. 第10424部分: 装置化. 睡眠窒息呼吸治疗设备(SABTE) (ISO/IEEE 11073-10424-2016); 英文版本EN ISO 11073-10424-2016

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e. g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This standard defines a common core of communication functionality for sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.

UNI EN ISO 11073-10424-2017健康信息学.个人健康设备通信.第10424部分：设备化.睡眠窒息呼吸治疗设备（SABTE）

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.

UNI EN ISO 17510-1-2009睡眠窒息呼吸治疗.第1部分:睡眠窒息呼吸治疗设备

La presente norma è la versione ufficiale in lingua inglese della norma europea EN ISO 17510-1 (edizione marzo 2009). La norma specifica i requisiti dei dispositivi di terapia respiratoria dell'apnea nel sonno per uso domiciliare e ospedaliero.