protocol european agreement exchang therapeut substanc human origin part gener provis label label print english french base model found annex protocol affix contain give set pack dispatch human blood dispatch contain temperatur maintain period transport condit requir deriv mention protocol product apparatu product apparatu refer part ii protocol steril pyrogen toxic recommend give set solvent requir dri product consign freedom toxic plastic blood transfus equip equip compli provis set annex protocol part ii specif provis human blood human blood blood mix suitabl anticoagul collect human subject normal health blood obtain human subject suffer suffer syphili blood test neg result evid syphilit infect ascertain medic examin studi anteced free diseas transmiss blood transfus blood withdrawn asept close system steril tube steril contain anticoagul solut contain steril equip pyrogen free withdraw complet contain immedi seal cool open immedi blood blood collect citrat solut acid reaction dextros antisept bacteriostat substanc ad volum anticoagul solut exce ml litr human blood haemoglobin concentr gram litr blood group blood group ab system determin examin corpuscl serum rh system examin corpuscl separ sampl donor blood nation standard nation recommend techniqu blood group techniqu term rh neg specif test shown absenc antigen du blood label rh posit blood exchang agreement recipi ab group storag human blood steril contain seal exclud micro organ store temperatur requir period examin transport higher temperatur period exce minut blood immedi cool label label contain give inform shown model label annex rhesu group written quot posit quot quot neg quot abbrevi form quot po quot quot neg quot human red cell concentr human red cell concentr unit human blood plasma remov red cell unit prepar cell compon present partial remov liquid content concentr consist residu plasma isoton artifici aqueou solut ad plasma remov volum red cell constitut total volum product greater red cell concentr appli approxim percentag erythrocyt volum haematocrit label oper requir prepar carri asept condit decant carri steril close system compress antisept bacteriostat agent ad blood group storag human blood label label contain give inform shown model label annex rhesu group written quot posit quot quot neg quot abbrevi form quot po quot quot neg quot artifici aqueou solut ad label volum composit dri human plasma dri human plasma prepar dry supernat fluid separ centrifug sediment quantiti human blood prepar antisept bacteriostat substanc ad dri human plasma obtain freez dry method avoid denatur protein dri product readili solubl quantiti water equal volum liquid substanc prepar protein concentr solut obtain gram litr show visibl evid product haemolysi haemaglutinin titr greater dri human plasma prepar donat blood donat shown danger level isohaemolysin determin sampl fresh serum immun haemaglutinin exclud plasma pool frozen hour collect blood steril unit test cultur ml dri human plasma prepar pool donat pool shown danger level immun haemaglutinin isohaemolysin exclud avoid untoward effect due product bacteri growth plasma individu donat evid bacteri contamin steril pool test cultur ml minim risk transmit serum hepat plasma prepar pool donat method shown diminish risk compar manner solubl water add quantiti water equal volum liquid sampl prepar substanc dissolv complet minut identif dissolv quantiti product volum water equal volum liquid prepar solut pass test precipit test specif antisera shown human plasma protein ii ml add suitabl amount thrombin calcium chlorid coagul occur acceler incub loss mass dry dri phosphoru pentoxid pressur exceed mm mercuri hour dri human plasma lose weight steril final product reconstitut steril examin suitabl bacteriolog method storag dri human plasma atmospher nitrogen vacuum steril contain seal exclud micro organ moistur protect light store temperatur label label contain give inform shown model label annex human albumin human plasma protein fraction human albumin human plasma protein fraction prepar protein compon form total protein mass plasma human blood method prepar produc materi meet requir final product liquid dri prepar addit suitabl stabil agent agent heat liquid state final contain hour order inactiv agent caus serum hepat prepar antisept bacteriostat substanc ad prepar human albumin mass protein present albumin prepar human plasma protein fraction protein mass albumin prepar milligram immunoglobulin gram product present final product freez dri milligram protein gram product human plasma protein fraction prepar solut total protein concentr gram litr human albumin prepar solut total protein concentr gram litr solubl dri product add water recommend volum dri prepar complet solubl stabil comparison solut heat treatment evid signific denatur protein solut detect estim viscos turbid measur ultracentrifug electrophoresi solut substanti free visibl particl heat agit mechan shaker hour temperatur identif precipit test specif antisera prepar shown human plasma protein ii electrophoresi move boundari techniqu accept condit shown protein fraction mobil albumin compon normal human plasma protein mass prepar human albumin protein mass prepar human plasma protein fraction sodium content sodium concentr sodium content salt poor human albumin exce millimol gram albumin prepar human albumin human plasma protein fraction sodium concentr exce mole litr solut reconstitut dri product potassium concentr potassium concentr human plasma protein fraction exce millimol litr solut reconstitut dri product acid ph prepar measur temperatur solut dilut protein concentr gram litr mean solut mole sodium chlorid litr loss mass dry dri prepar dri phosphoru pentoxid pressur exceed mm mercuri hour lose weight steril final product steril examin suitabl bacteriolog method storag dri human albumin atmospher nitrogen vacuum steril contain seal exclud micro organ moistur protect light store temperatur solut human albumin human plasma protein fraction steril contain seal exclud micro organ protect light store temperatur label label contain give inform shown model label annex solut date prepar date heat treatment final contain human normal immunoglobulin human normal immunoglobulin prepar plasma protein prepar human blood antibodi normal adult obtain pool liquid human plasma donor method prepar produc materi meet requir prescrib prevent transmiss serum hepat final product addit method prepar antibodi contain start materi concentr adequ amount final product procedur shown final prepar satisfactori respect titrat start materi final product antibodi viru bacteri toxin antibodi chosen recogn method titrat prepar antisept bacteriostat substanc ad suitabl preserv stabil agent ad final prepar maintain bacteri steril stabil final product final product issu solut immunoglobulin concentr gram litr identif precipit test specif antisera shown human plasma protein ii electrophoresi move boundari techniqu accept condit mass protein mobil gamma compon globulin normal human plasma stabil heat final solut dai visibl evid precipit turbid advis carri test ultracentrifug method determin extent degrad product smaller molecular weight compon method approv nation control author acid ph final solut measur temperatur solut dilut protein concentr gram litr mean solut mole sodium chlorid litr stabil final product steril examin suitabl bacteriolog method storag human immunoglobulin solut steril contain seal exclud microorgan protect light store temperatur label label contain give inform shown model label annex date prepar date fill final contain human specif immunoglobulin human specif immunoglobulin antibodi design viral bacteri agent prepar pool limit number donat human specif immunoglobulin includ requir human immunoglobulin anti tetanu human immunoglobulin anti vaccinia specif immunoglobulin develop intern standard exist assai relat standard potenc express intern unit human immunoglobulin anti vaccinia iu ml vaccinia antibodi determin neutral test chorio allanto membran tissu cultur human immunoglobulin anti tetanu iu ml tetanu antitoxin determin neutral test anim human specif immunoglobulin meet requir section human normal immunoglobulin depend antibodi content immunoglobulin concentr final solut vari gram litr label label contain give inform shown model label annex addit label state potenc intern unit term intern standard intern refer prepar dri human fibrinogen dri human fibrinogen dri prepar solubl constitut liquid human plasma addit thrombin transform fibrin method prepar produc materi meet requir prescrib minim risk transmit serum hepat plasma pool prepar fibrinogen donat prepar antisept bacteriostat substanc ad final product freez dri solubl add water recommend volum dri prepar complet solubl precipit occur minut reconstitut identif precipit test specif antisera shown human plasma protein ii freshli reconstitut product properti clot addit thrombin thrombin ad solut human fibrinogen concentr fresh normal plasma clot occur time clot occur fresh normal plasma addit thrombin iii clottabl protein total protein clottabl thrombin loss mass dry prepar dri phosphoru pentoxid pressur exceed mm mercuri hour lose weight steril final product reconstitut steril examin suitabl bacteriolog method storag human fibrinogen atmospher nitrogen vacuum steril contain seal exclud micro organ moistur protect light store temperatur recommend label label contain give inform shown model label annex date prepar date place final solut freez dry dri frozen human coagul factor viii requir appli donor donor good health free communic diseas accord criteria adopt dri human plasma ii requir appli prepar steril atox final product steril pyrogenfre cryoprecipit perform plastic bag product organ solvent foreign substanc present freez mixtur passag product wall plastic bag prevent place bag imperm bag period immers risk plastic bag tear storag frozen state reduc keep bag protect box erythrocyt leukocyt platelet centrifug elimin form element blood complet collect solubl addit quantiti solvent result complet solut dry product minut small easili separ aggreg fibrinogen persist stabil prepar conserv show sign precipit hour dissolv potenc reconstitut prepar minimum quantiti factor viii unit potenc ml averag normal fresh plasma potenc determin method approv compet nation author abens irregular antibodi prepar intend patient ab group titr anti anti antibodi exceed identif precipit test specif antisera show product human plasma protein loss mass dry freez dri prepar dri phosphoru pentoxid pressur exceed mm mercuri hour lose weight storag human factor viii store deepfrozen state temperatur freez dri state protect light dri prepar atmospher nitrogen vacuo steril vial stopper exclud micro organ humid storag frozen state exce month dri state year prepar retest minimum requir potenc iii label label prepar give inform shown model label annex dri human coagul factor ix requir appli donor donor good health free communic diseas accord criteria adopt dri human plasma ii requir appli concentr steril atox final product test method steril pyrogen free free undesir vaso depressor respiratori effect test absenc vaso depressor effect perform dog cat solubl addit quantiti solvent result complet solut minut thromboplastin activ absenc free thrombin recalcif time normal plasma measur presenc equal volum dilut reconstitut product second reconstitut product equal volum fibrinogen ad coagul hour potenc reconstitut prepar minimum quantiti factor ix unit potenc ml averag normal fresh plasma potenc determin method approv compet nation author yield stabil vivo method prepar inject dose unit kg bodi weight rapidli administ intraven batch materi patient minut absenc specif inhibitor basal condit averag rise unit litr plasma persist hour averag rise unit litr plasma identif precipit test specif antisera show product sole human plasma protein loss mass dry dri phosphoru pentoxid pressur exceed mm mercuri hour product lose weight storag prepar store dry temperatur period storag exce year potenc prepar retest iii label label prepar give inform shown model label annex annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex bi au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex suit annex continu conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex suit annex continu conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex au protocol annex protocol conseil de europ council europ accord européen relatif échang de substanc thérapeutiqu origin humain european agreement exchang therapeut substanc human origin annex ii protocol council europ european agreement exchang therapeut substanc human origin freedom toxic plastic blood transfus equip chemic test test intend appli plastic blood transfus equip equip consist main categori plastic contain collect separ storag blood blood product plastic set take give blood test carri materi steril method final steril equip materi includ plastic make contain tube contain blood take give set test contain carri contain fill anticoagul solut test carri contain fill anticoagul solut limit test section iii anticoagul solut account evalu result test contain manufactur transfus equip requir disclos health author detail formul plastic materi materi materi manufactur equip sourc compon materi materi method manufactur altern compound refer number detail manufactur equip natur process addit adhes method steril chang permit forego prior submiss approv health author batch raw materi manufactur equip identifi batch numer record manufactur equip identif number batch transfus equip made result test relev batch practic precaut reduc risk adventiti contamin stage manufactur process prepar extract blank total test decrib requir cm plastic total surfac area side plastic sampl sheet form surfac area cm sampl print label cut piec cm tube length cm calcul diamet cm outer diamet cm tube cut lengthwis section measur approxim cm extract ml water cm surfac area piec plastic film tube contain borosil glass ml pyrogen free distil water obtain effici glass condens surfac collect tube open contain cover invert beaker contain heat satur steam minut autoclav quickli cool room temperatur volum adjust ml pyrogen free distil water signific plastic specimen tend stick slightli plastic contact anticoagul solut piec similar contain cold distil water ml shaken time repeat heat sensit plastic materi heat autoclav heat hour blank prepar made manner omit plastic test extract oxidiz matter ml extract erlenmey flask borosil glass add ml millimol potassium permangan solut litr ml mole sulphur acid litr boil mixtur minut cool solut rapidli add potassium iodid drop starch solut titrat solut millimol sodium thiosulph litr time carri blank titrat differ volum thiosulph titrat exce ml solut millimol sodium thiosulph litr chlorid extract compli suitabl limit test chlorid equival mole chlorid litr ammonia extract compli suitabl limit test ammonia equival mole nh litr phosphor acid phosphat extract compli limit test phosphat limit test phosphat evapor ml extract dryness kjeldahl flask cool residu add drop sulphur acid ml nitric acid heat mixtur white fume cool add drop perchlor acid heat gentli half hour cool residu add water ml transfer ml solut ml titrat flask add ml ammonium molybd sulphur acid solut ml freshli prepar solut ascorb acid concentr heat water bath minut cool dilut mixtur ml green blue colour solut intens obtain treat ml blank solut manner acid alkalin ml extract colour red addit drop phenolphthalein solut requir ml solut millimol sodium hydroxid litr produc red colour remov colour addit ml solut millimol hydrochlor acid litr addit drop methyl red solut produc red orang red colour residu evapor evapor ml extract dryness water bath dry constant weight residu weigh mg clariti colour extract view thick cm clear colourless compar blank tast smell extract compar blank odourless tasteless special element extract compli suitabl limit test element arsen chromium copper lead silicon silver tin equival ii cadmium equival residu ignit plastic materi ignit constant weight leav mg residu heavi metal dissolv residu ignit minimum quantiti solut mole hydrochlor acid litr heat carri suitabl limit test heavi metal plastic materi compli limit exceed microgram gram calcul pb ii biolog test test undu toxic carri initi evalu plastic formul intend fabric contain take give set extract batch materi approv formul extract procedur nation pharmacopoeia method approv nation control author extract defin note test freedom pyrogen carri initi evalu plastic formul intend fabric contain take give set extract batch materi approv formul extract routin control contain take give set extract procedur nation pharmacopoeia method approv nation control author incid pyrogen test extract decid nation control author extract defin note test haemolyt effect buffer system perform initi evalu plastic formul intend fabric contain take give set batch materi approv formul extract paragraph method accept limit appendix present annex test vivo surviv red cell carri initi evalu plastic formul intend fabric contain blood chang made agre formul test repeat suggest method accept limit appendix present annex note extract prepar ad extract pyrogen free sodium chlorid final concentr gram litr extract transfus set fill transfus set complet steril pyrogen free solut gram sodium chlorid litr clamp end secur immers fill set complet hour water maintain plastic contain contain fill anti coagul solut empti rins ml portion steril pyrogen free distil water temperatur fill contain ml steril pyrogen free solut gram sodium chlorid litr close secur immers hour horizont posit water maintain collect content contain extract transfus set pass ml portion steril pyrogen free sodium chlorid solut concentr gram litr room temperatur transfus set flow rate approxim ml minut pool effluent test solut obtain plastic contain empti pass ml portion steril pyrogen free solut gram sodium chlorid litr room temperatur collect tube plastic contain remain contain minut pool effluent discharg transfer tube test solut obtain plastic contain anticoagul paragraph iii iii requir anticoagul solut plastic contain contain quantiti formul anticoagul solut label volum blood collect anticoagul solut ingredi prepar satisfi requir nation pharmacopoeia countri concern anticoagul solut satisfi requir nation pharmacopoeia countri concern regard limit heavi metal absenc particul matter freedom toxic pyrogen appendix biolog test limit method test undu toxic item ii annex limit nation pharmacopoeia test freedom pyrogen item ii annex limit nation pharmacopoeia test haemolyt effect buffer system item ii annex limit salt solut equival solut gram nacl litr electrolyt osmot action concern produc haemolysi higher salt solut gram litr differ haemolysi caus control solut method test vivo surviv red cell item ii annex limit erythrocyt human blood acd anticoagul store dai post transfus surviv time hour determin method propos suggest method method iso tc wgd app ashbi techniqu ashbi determin length life transfus blood corpuscul man exp med young platzer rafferti differenti agglutin human erythrocyt lab clin med gibson scheitlin method gibson scheitlin method emploi radio activ chromium assai viabil human erythrocyt return circul refriger storag lab clin med strumia method strumia taylor sampl colwel dugan limit surviv studi erythrocyt tag cr blood cr techniqu button gibson walter simultan determin volum red cell plasma surviv studi store blood transfus recommend method radioisotop red cell surviv studi brit haemat strasbourg dai april franz arasek secretari gener certifi true copi sole origin document english french deposit archiv council europ erik harremo director legal affair council europ