【英文标准名称】:StandardSpecificationforIdentificationandConfigurationofPrefilledSyringesandDeliverySystemsforDrugs(ExcludingPharmacyBulkPackages)
【原文标准名称】:药物(不包括大批量的药方用药)用填装注射器和交货系统的识别和外形
【标准号】:ASTMD4775/D4775M-2009
【标准状态】:现行
【国别】:
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:D10.32
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:deliverysystems;labelrequirements;legibility;prefilledsyringes;Drugapplications;Drugcontainers/labels;Identification--drugs;Intravenousinjection;Labels/labeling--specifications;Legibility;Medicalmaterials/applications--specifications;
【摘要】:1.1Thisspecificationcoverstheidentificationof:1.1.1Thedrugcontainedintheprefilledsyringeordeliverysystem.1.1.2Theconcentration,volume,andtotalamountofthedrug,andwhetheritistobedilutedpriortoadministration.1.2ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.Note18212;ThevaluesinSIunitsaretherecommendedvalues.
【中国标准分类号】:
【国际标准分类号】:55_180_40
【页数】:2P.;A4
【正文语种】: