家用制氧机适用GB 9706.1—2020及其系列标准的设计变更探讨

Design Changes for Household Oxygenerator Applicable to GB 9706.1—2020 and Its Series of Standards

目的为家庭护理环境中使用的医用分子筛制氧机(以下简称家用制氧机)产品适用GB 9706.1—2020及其系列标准的设计变更和质量控制提供参考。方法依据GB 9706.1—2020及其相关强制性系列标准的试验要求和符合性判定原则,结合家用制氧机的使用环境,从通用安全要求和专用安全要求角度探讨产品的设计变更要点,总结关键设计变更要点。结果与结论家用制氧机适用的GB 9706.1—2020及其系列标准已于2023年5月1日起强制实施,产品设计变更要点主要有风险管理过程及基本性能识别、外部标记、机械结构设计要求、内部结构设计调整、外壳设计调整、报警要求、可用性设计要求、可编程医用电气系统要求等。家用制氧机生产企业应根据这些标准要求对产品实施有效的设计变更,提升其可用性和标准的合规性,以助力产品快速进入市场。

Objective To provide a reference for the design changes and quality control of the medical molecular sieve oxygenerator used in home care environments(hereinafter referred to as household oxygenerator)applicable to GB 9706.1—2020 and its series of standards.Methods Based on the test requirements and compliance judgment principles of GB 9706.1—2020 and its related mandatory standards,combined with the usage environment of household oxygenerator,the key points of product design changes were investigated from the perspectives of general safety requirements and special safety requirements,and the key design change points were summarized.Results and Conclusion The GB 9706.1—2020 and its series of standards applicable to household oxygenerator have been mandatorily implemented on May 1,2023.The main points of product design changes include risk management process and basic performance identification,external labeling,mechanical structure design,internal structure design adjustment,shell design adjustment,requirements for alarm,requirements for usability design,requirements for programmable medical electrical system,etc.Household oxygenerator manufacturers should carry out effective design changes for the products in accordance with these the standard requirements,improve their usability and compliance standards,and thus facilitate the product's rapid and compliant entry into the market.