标准摘要
[中文适用范围]: 本国际标准化组织标准规定了用于评估自主呼吸人类肺功能的高峰呼气流量计(pefm)的要求。本标准涵盖所有测量自主呼吸人类高峰呼气流量率的医疗设备,无论是作为集成肺功能医疗设备的一部分,还是作为独立医疗设备。应用本国际标准化组织的标准的产品规划和设计应考虑产品在其生命周期中的环境影响。附录E中讨论了环境因素。 [外文原描述]: ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device. Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E. NOTE Additional aspects of environmental impact are addressed in ISO 14971.
英文名称Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans