標(biāo)準(zhǔn)號(hào)：CGA M-9-2008
中文標(biāo)準(zhǔn)名稱：對(duì)壓縮醫(yī)用氣體填充設(shè)施的大量氣體供應(yīng)商指紋分析進(jìn)行維護(hù)
英文標(biāo)準(zhǔn)名稱：Maintaining bulk gas supplier fingerprint analysis at compressed medical gas filling facilities
標(biāo)準(zhǔn)類型：G00
發(fā)布日期：2008/1/1 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國(guó)標(biāo)準(zhǔn)分類號(hào)：G00
引用標(biāo)準(zhǔn)：CGA M-7;United States Pharmacopeia and National Formulary, United States Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852. www.usp.org
適用范圍：This publication provides criteria that medical gas transfill companies can use to satisfy FDA's fingerprinting concerns. It applies to the procurement of bulk medical gas by transfill companies and the requirement that bulk carbon dioxide suppliers provide appropriate certification regarding their product's compliance to current good manufacturing practices (CGMP) and USP specifications.