commiss direct ec march implement direct ec european parliament council technic requir blood blood compon text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon amend direct ec point paragraph articl thereof direct ec lai standard qualiti safeti collect test human blood blood compon intend purpos process storag distribut intend transfus ensur high level human health protect order prevent transmiss diseas blood blood compon ensur equival level qualiti safeti direct ec call establish specif technic requir direct lai technic requir account council recommend ec june suitabl blood plasma donor screen donat blood european commun recommend council europ opinion scientif committe medicin product medic devic monograph european pharmacopoeia respect blood blood compon start materi manufactur proprietari medicin product recommend world health organis intern experi field blood blood compon import countri includ start materi raw materi manufactur medicin product deriv human blood human plasma meet qualiti safeti requir set direct regard blood blood compon collect sole purpos exclus autolog transfus autolog donat specif technic requir laid requir articl direct ec donat identifi separ donat ensur transfus patient determin common definit technic terminolog order ensur consist implement direct ec measur provid direct accord opinion committe set direct ec adopt direct articl definit purpos direct definit set annex appli articl provis inform prospect donor member state ensur blood establish provid prospect donor blood blood compon inform set part annex ii articl inform requir donor member state ensur agreement willing commenc donat blood blood compon donor provid inform set part annex ii blood establish articl elig donor blood establish ensur donor blood blood compon compli elig criteria set annex iii articl storag transport distribut condit blood blood compon blood establish ensur storag transport distribut condit blood blood compon compli requir set annex iv articl qualiti safeti requir blood blood compon blood establish ensur qualiti safeti requir blood blood compon compli requir set annex articl autolog donat blood establish ensur autolog donat compli requir set direct ec specif requir set direct autolog donat identifi separ allogen donat articl valid member state ensur test process refer annex ii valid articl transposit prejudic articl direct ec member state bring forc law regul administr provis compli direct februari latest forthwith commun commiss text provis correl tabl provis direct member state adopt provis refer direct accompani refer occas offici public member state determin refer made member state commun commiss text main provis nation law adopt field cover direct articl entri forc direct enter forc dai public offici journal european union articl addresse direct address member state brussel march commiss david byrn member commiss oj oj annex definit refer articl quot autolog donat quot mean blood blood compon collect individu intend sole subsequ autolog transfus human applic individu quot allogen donat quot mean blood blood compon collect individu intend transfus individu medic devic start materi raw materi manufactur medicin product quot valid quot mean establish document object evid requir specif intend consist fulfil quot blood quot mean singl blood donat quot cryopreserv quot mean prolong storag life blood compon freez quot plasma quot mean liquid portion blood cell suspend plasma separ cellular portion blood collect therapeut fresh frozen plasma process cryoprecipit cryoprecipit deplet plasma transfus manufactur medicin product deriv human blood human plasma prepar pool platelet pool leucocyt deplet platelet suspens red cell prepar exchang transfus perinat transfus quot cryoprecipit quot mean plasma compon prepar plasma fresh frozen freez thaw precipit protein subsequ concentr suspens precipit protein small volum plasma quot wash quot mean process remov plasma storag medium cellular product centrifug decant supernat liquid cell addit isoton suspens fluid turn gener remov replac centrifug suspens centrifug decant replac process repeat time quot red cell quot mean red cell singl blood donat larg proport plasma donat remov quot red cell buffi coat remov quot mean red cell singl blood donat larg proport plasma donat remov buffi coat larg proport platelet leucocyt donat unit remov quot red cell leucocyt deplet quot mean red cell singl blood donat larg proport plasma donat remov leucocyt remov quot red cell addit solut quot mean red cell singl blood donat larg proport plasma donat remov nutrient preserv solut ad quot addit solut quot mean solut specif formul maintain benefici properti cellular compon storag quot red cell buffi coat remov addit solut quot mean red cell singl blood donat larg proport plasma donat remov buffi coat larg proport platelet leucocyt donat unit remov nutrient preserv solut ad quot buffi coat quot mean blood compon prepar centrifug unit blood consider proport leucocyt platelet quot red cell leucocyt deplet addit solut quot mean red cell singl blood donat larg proport plasma donat remov leucocyt remov nutrient preserv solut ad quot red cell apheresi quot mean red cell apheresi red cell donat quot apheresi quot mean method obtain blood compon machin process blood residu compon blood return donor end process quot platelet apheresi quot mean concentr suspens blood platelet obtain apheresi quot platelet apheresi leucocyt deplet quot mean concentr suspens blood platelet obtain apheresi leucocyt remov quot platelet recov pool quot mean concentr suspens blood platelet obtain process blood unit pool platelet unit separ quot platelet recov pool leucocyt deplet quot mean concentr suspens blood platelet obtain process blood unit pool platelet unit separ leucocyt remov quot platelet recov singl unit quot mean concentr suspens blood platelet obtain process singl unit blood quot platelet recov singl unit leucocyt deplet quot mean concentr suspens blood platelet obtain process singl blood unit leucocyt remov quot plasma fresh frozen quot mean supernat plasma separ blood donat plasma collect apheresi frozen store quot plasma cryoprecipit deplet transfus quot mean plasma compon prepar unit plasma fresh frozen compris residu portion cryoprecipit remov quot granulocyt apheresi quot mean concentr suspens granulocyt obtain apheresi quot statist process control quot mean method qualiti control product process reli system analysi adequ sampl size measur product process annex ii inform requir refer articl part inform provid prospect donor blood blood compon accur educ materi understand member gener public essenti natur blood blood donat procedur compon deriv blood apheresi donat import benefit patient allogen autolog donat reason requir examin health medic histori test donat signific quot inform consent quot allogen donat deferr temporari perman deferr reason individu donat blood blood compon risk recipi autolog donat possibl deferr reason donat procedur place presenc health risk individu donor recipi autolog blood blood compon inform protect person data unauthoris disclosur ident donor inform donor health result test perform reason individu make donat detriment health specif inform natur procedur involv allogen autolog donat process respect risk autolog donat possibl autolog blood blood compon suffic intend transfus requir inform option donor chang mind donat prior proceed possibl withdraw defer time donat process undu embarrass discomfort reason import donor inform blood establish subsequ event render prior donat unsuit transfus inform respons blood establish inform donor mechan test result show abnorm signific donor health inform unus autolog blood blood compon discard transfus patient inform test result detect marker virus hiv hbv hcv relev blood transmiss microbiolog agent result donor deferr destruct collect unit inform opportun donor question time part inform obtain donor blood establish donat identif donor person data uniqu risk mistaken ident distinguish donor contact detail health medic histori donor health medic histori provid questionnair person interview perform qualifi healthcar profession includ relev factor assist identifi screen person donat present health risk possibl transmit diseas health risk signatur donor signatur donor donor questionnair countersign health care staff member respons obtain health histori confirm donor read understood educ materi provid opportun question provid satisfactori respons question ask inform consent proce donat process inform case autolog donat donat blood blood compon suffici intend transfus requir acknowledg inform provid donor true knowledg annex iii elig criteria donor blood blood compon refer articl accept criteria donor blood blood compon except circumst individu donat donor compli criteria authoris qualifi healthcar profession blood establish case document subject qualiti manag provis articl direct ec criteria appli autolog donat ag bodi weight donor gt tabl gt haemoglobin level donor blood gt tabl gt protein level donor blood gt tabl gt platelet level donor blood gt tabl gt deferr criteria donor blood blood compon test deferr period asterisk requir donat exclus plasma fraction perman deferr criteria donor allogen donat gt tabl gt temporari deferr criteria donor allogen donat infect durat deferr period infecti ill prospect donor defer week date full clinic recoveri deferr period appli infect list tabl gt tabl gt exposur risk acquir transfus transmiss infect gt tabl gt vaccin gt tabl gt temporari deferr gt tabl gt deferr epidemiolog situat gt tabl gt deferr criteria donor autolog donat gt tabl gt annex iv storag transport distribut condit blood blood compon refer articl storag liquid storag gt tabl gt cryopreserv gt tabl gt transport distribut transport distribut blood blood compon stage transfus chain condit maintain integr product addit requir autolog donat autolog blood blood compon identifi store transport distribut separ allogen blood blood compon autolog blood blood compon label requir direct ec addit label includ identif donor warn quot autolog transfus quot annex qualiti safeti requir blood blood compon refer articl blood compon gt tabl gt qualiti control requir blood blood compon blood blood compon compli technic qualiti measur meet accept result bacteriolog control collect manufactur process perform member state measur ensur import blood blood compon countri includ start materi raw materi manufactur medicin product deriv human blood human plasma meet equival standard qualiti safeti laid direct autolog donat measur mark asterisk recommend gt tabl gt