麻醉和呼吸设备.与氧气的兼容性

[中文适用范围]： 本国际标准规定了麻醉和呼吸应用材料、部件和装置的氧气相容性要求，这些材料、部件和装置在正常条件下或在气压大于 50 kPa 的单一故障条件下可以与氧气接触。 此外，本国际标准还提供了根据其氧相容性的现有数据选择材料和组件以及进行风险分析（包括解决燃烧和/或分解产物的毒性）的一般指南。 本国际标准涉及的兼容性方面包括清洁度、耐燃性以及设计、制造、维护和处置阶段燃烧和/或分解产物的毒性。 本国际标准不适用于生物相容性。 本国际标准适用于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、医疗供应装置、柔性连接、流量计量装置、麻醉工作站和肺呼吸机 [外文原描述]： 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.