家庭环境下使用的医疗设备检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY 0784-2010医用电气设备医用脉搏血氧仪设备基本安全和主要性能专用要求

引用GB 9706.1-2007的第1章,不包括以下内容。修改(增加在1.1末尾处) 本标准详细描述了适用于人体使用的脉搏血氧仪设备的基本安全和主要性能的专用要求,该设备包括在正常使用中的任何必要的部件,如脉搏血氧监护仪、脉搏血氧探头、探头电缆延长线等。这些要求也适用于经再加工的脉搏血氧仪设备,包括脉搏血氧监护仪,血氧探头和探头电缆延长线等。脉搏血氧仪设备的应用范围包括,而不仅限于,在医疗保健机构和家庭中估计患者的动脉血氧饱和度和脉率。本标准不适用于实验室研究使用的脉搏血氧仪设备,也不适用于需采集患者血液样本的血氧仪。本标准不适用于胎儿专用脉搏血氧仪设备。本标准不适用于放置于患者环境之外显示SpO<下标 2>数值的遥测或主(从)设备。本标准的要求替代或修改了GB 9706.1-2007,并预期优先于相应的通用要求。

DIN CEN ISO/TR 12296-2013人类工效学. 医疗保健行业人员的人工操作 (ISO/TR 12296-2012); 德文版本CEN ISO/TR 12296-2013

The technical report DIN CEN ISO/TR 12296 provides guidance for assessing the problems and risks associated with manual patient handling in the healthcare sector, and for identifying and applying ergonomic strategies and solutions to those problems and risks. Its main goals are - to improve caregivers' working conditions by decreasing biomechanical overload risk, thus limiting work-related illness and injury, as well as the consequent costs and absenteeism, and - to account for patients' care quality, safety, dignity and privacy as regards their needs, including specific personal care and hygiene. It is intended for all users (or caregivers and workers) involved in healthcare manual handling and, in particular, healthcare managers and workers, occupational safety and health caregivers, producers of assistive devices and equipment, education and training supervisors, and designers of healthcare facilities. Its recommendations are primarily applicable to the movement of people (adults and children) in the provision of healthcare services in purposely built or adapted buildings and environments. Some recommendations can also be applied to wider areas (e. g. home care, emergency care, voluntary caregivers, cadaver handling). The recommendations for patient handling take into consideration work organization, type and number of patients to be handled, aids, spaces where patients are handled, as well as caregivers' education and awkward postures, but do not apply to object (movement, transfer, pushing and pulling) or animal handling. Task joint analysis in a daily shift involving patient handling, pulling and pushing or object handling and transport is not considered.

DIN EN ISO 11073-00103-2017健康信息学. 个人保健装置通信. 第00103部分: 综述(ISO/IEEE 11073-00103-2015); 英文版本EN ISO 11073-00103-2017

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e. g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

BS EN ISO 18778-2009呼吸设备.婴儿监视器.详细要求(ISO 18778-2005)

IEC 60601-1:1988, Clause 1, applies except as follows:Amendments (add at end of 1.1):1.1This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.This International Standard does not apply to monitors intended for use in health care facilities/institutions.The requirements of this International Standard, which replace or modify the requirements ofIEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over thecorresponding general requirements.1.4Addition:NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.