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 oxy generator)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 oxy generator 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 oxy generator 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.
关键词
家用制氧机/GB/9706.1-2020系列标准/医用分子筛制氧机/设计变更
Key words
household oxy generator/GB 9706.1-2020 and its series of standards/molecular sieve oxygen generator/design change
万方数据