ISO 15001:2010 麻醉和呼吸设备 与氧气的兼容性

标准编号：ISO 15001:2010

中文名称：麻醉和呼吸设备 与氧气的兼容性

英文名称：Anaesthetic and respiratory equipment — Compatibility with oxygen

发布日期：2010-06

标准范围

ISO 15001:2010规定了麻醉和呼吸应用材料、部件和设备的氧气兼容性要求，这些材料、部件或设备在正常条件下或在单一故障条件下，在大于50kPa的气体压力下可与氧气接触。此外，ISO 15001:2010给出了根据可用的氧气兼容性数据选择材料和组件的一般指南，以及进行风险分析的一般指南（包括处理燃烧和/或分解产物的毒性）。ISO 15001:2010规定的兼容性方面包括设计、制造、维护和处置阶段的清洁度、耐燃性以及燃烧和/或分解产物的毒性。ISO 15001:2010适用于ISO/TC 121范围内的麻醉和呼吸设备，例如医用气体管道系统、压力调节器、终端装置、医用供应装置、柔性连接件、流量计量装置、麻醉工作站和肺部呼吸机。

ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.Additionally, ISO 15001:2010 gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition.Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.

标准预览图