【团体标准】 琼脂糖层析介质通用技术要求

本标准给出了琼脂糖层析介质的产品分类，规定了其基本要求、材料要求、外观要求、性能要求、安全要求、环保要求，以及标志、标签、包装、运输和贮存等内容，适用于以琼脂糖为主要基质的层析介质设计与生产。其中，产品按耐压特性分为交联琼脂糖层析介质和高刚性琼脂糖层析介质；材料方面对乙醇含量、琼脂糖纯度等有明确要求；外观要求介质呈饱满球形、表面光滑等；性能要求涵盖物理性能（如平均粒径、最高流速等）、化学性能（如5-羟甲基糠醛脱落量等）、生物性能（如菌落总数、内毒素含量等）；安全要求包括无已知人类病原体、急性经口毒性及重金属限量等；环保要求涉及废弃物处置和污染物排放需符合相关标准；同时还对标志标签、包装运输和贮存条件作出了规定。Thisstandardgivestheproductclassificationofagarosechromatographymedia,andstipulatesitsbasicrequirements,materialrequirements,appearancerequirements,performancerequirements,safetyrequirements,environmentalprotectionrequirements,aswellassigns,labels,packaging,transportationandstorage,etc.,whichissuitableforthedesignandproductionofchromatographymediawithagaroseasthemainmatrix.Amongthem,theproductsaredividedintocross-linkedagarosechromatographymediumandhigh-rigidityagarosechromatographymediumaccordingtothepressureresistancecharacteristics;Intermsofmaterials,thereareclearrequirementsforethanolcontentandagarosepurity;Theappearancerequiresthatthemediumisfullandspherical,andthesurfaceissmooth;Theperformancerequirementsincludephysicalproperties(suchasaverageparticlesize,maximumflowrate,etc.),chemicalproperties(suchastheamountof5-hydroxymethylfurfuralshed,etc.),biologicalproperties(suchastotalnumberofcolonies,endotoxincontent,etc.);Safetyrequirementsincludenoknownhumanpathogens,acuteoraltoxicityandheavymetallimits;Environmentalprotectionrequirementsrelatedtowastedisposalandpollutantdischargemustmeetrelevantstandards;Atthesametime,thereareprovisionsformarking,labeling,packaging,transportandstorageconditions.