一、YY1468-2016《用(yong)于醫用(yong)氣體管道系統的(de)氧氣濃縮器供氣系統》

由(you)于(yu)分(fen)子(zi)篩(shai)制(zhi)氧(yang)(yang)(yang)(yang)運用(yong)(yong)(yong)(yong)(yong)越來越廣(guang)泛，國家法規(gui)監(jian)管(guan)也越發(fa)(fa)規(gui)范化，經多(duo)輪研(yan)討后送審，正式(shi)發(fa)(fa)布(bu)《用(yong)(yong)(yong)(yong)(yong)于(yu)醫用(yong)(yong)(yong)(yong)(yong)氣(qi)(qi)(qi)體(ti)(ti)管(guan)道(dao)系(xi)統的(de)(de)氧(yang)(yang)(yang)(yang)氣(qi)(qi)(qi)濃縮器供(gong)氣(qi)(qi)(qi)系(xi)統》。規(gui)范中(zhong)指出分(fen)子(zi)篩(shai)制(zhi)氧(yang)(yang)(yang)(yang)系(xi)統制(zhi)取的(de)(de)氧(yang)(yang)(yang)(yang)氣(qi)(qi)(qi)[富氧(yang)(yang)(yang)(yang)空氣(qi)(qi)(qi)，93%氧(yang)(yang)(yang)(yang)]可以用(yong)(yong)(yong)(yong)(yong)于(yu)醫用(yong)(yong)(yong)(yong)(yong)氣(qi)(qi)(qi)體(ti)(ti)管(guan)道(dao)系(xi)統，作為中(zhong)國藥(yao)典中(zhong)的(de)(de)“氧(yang)(yang)(yang)(yang)"的(de)(de)替代(dai)品，并可與含(han)有100%醫用(yong)(yong)(yong)(yong)(yong)氧(yang)(yang)(yang)(yang)氣(qi)(qi)(qi)的(de)(de)供(gong)氣(qi)(qi)(qi)源(yuan)（即(ji)氧(yang)(yang)(yang)(yang)氣(qi)(qi)(qi)瓶或低溫容器）組(zu)合使用(yong)(yong)(yong)(yong)(yong)。

技(ji)術要(yao)求：氧(yang)氣濃(nong)度90%-96%，水分含(han)量不大于0.0067%，一(yi)氧(yang)化(hua)碳濃(nong)度不大于0.0005%，二氧(yang)化(hua)碳濃(nong)度不大于0.03%，氮氧(yang)化(hua)物不大于0.0002%，其他氣態氧(yang)化(hua)物質溶(rong)液(ye)應無(wu)色。

2021年(nian)2月6日，國家(jia)藥典(dian)委員會修(xiu)改公布了(le)“關于氧(yang)國家(jia)藥品標準草(cao)案"其中對(dui)醫用氧(yang)的純度及(ji)氧(yang)中痕量(liang)一(yi)氧(yang)化(hua)碳(tan)、二氧(yang)化(hua)碳(tan)、水分(fen)的含量(liang)及(ji)其檢測方法都做(zuo)了(le)具體(ti)規定。