ࡱ> "&%$##` b bjbj .R,,,8-2-=502.2.:l.l.l.l... .4444444$m6h8p4.l.l...4l.l.4000.l.l.40.4000l.&. Z,0/00 50=50E9/pE90E90X..0.....44"0^...=5....$  Form 3.0Evaluation Criteria The mandatory criteria for all medical devices when considering a clinical evaluation is: TGA registration as applicable for the device Compliant with all relevant Australian standards and therapeutic goods orders prior to commencing a proposed evaluation and trial. Standard Criteria PPPresentation Clear & legible labelling; instructions are in English and easily understood54321PPPackaging performance Is packaging robust to adequately protect product; packaging is removed easily to appropriately expose product54321CPPerformance How does the product function during clinical application54321CCompatibility Does the product fit with other products being used54321DDisposal How easy was the product to dispose of safely & appropriately54321 Key Criteria 54321543215432154321 Evaluation CriteriaWeightingPPPhysical performanceCPClinical PerformanceCCompatibilityDDisposalTotal 100 Percent Acceptable Not acceptable office use only     Clinical Products Evaluation Committee  EMBED PBrush  Clinical Products Evaluation Committee Page  PAGE 1 of  NUMPAGES 1    z- ? B O > J 2 @ n y vi[ihh5CJ ^JaJ hhCJ ^JaJ hhCJOJQJaJhph5OJQJh:_Nh5OJQJ\hOJQJhQ<hOJQJhuhCJOJQJaJh+h5:^JaJ h56CJOJQJ^JaJ&h+h56CJOJQJ^JaJhCJOJQJaJ"  0kd$$Ifl0 D%] O  t&&0&644 l` &ap&&yt2i$$Ifa$gd2il $Ifgd2ilgd a  z+ - ? B O $Ifgd2igd  $Ifgd2ikd$$IfTl4֞b!#%<JKKKK t0d&44 layt2iT 0 2 4 6 8 : $Ifgd2i: ; >  $Ifgd2ikd$$IfTl&֞b!#%<JKKKK t0d&44 layt2iT> J $Ifgd2i  $Ifgd2ikd$$IfTl&֞b!#%<JKKKK t0d&44 layt2iT $Ifgd2i  $Ifgd2ikd}$$IfTl&֞b!#%<JKKKK t0d&44 layt2iT ' ) + - / 1 $Ifgd2i1 2 3 gdkdj$$IfTl&֞b!#%<JKKKK t0d&44 layt2iT3 @ I R T V X Z \ $Ifgd2igd\ ] f " $Ifgd2ikdW$$Ifl֞"> *"$ t0f&644 layt2if o q s u w y $Ifgd2iy z " $Ifgd2ikd`$$Ifl֞"> *"$ t0f&644 layt2i $Ifgd2i " $Ifgd2ikdi$$Ifl֞"> *"$ t0f&644 layt2i $Ifgd2i "gdkdr$$Ifl֞"> *"$ t0f&644 layt2i ekdu $$IflF$o t06&6    44 layt2i $Ifgd2i  neee $Ifgd2ikd( $$IflF$o t06&6    44 layt2i   neee $Ifgd2ikd $$IflF$o t06&6    44 layt2i   ' ( neee $Ifgd2ikd $$IflF$o t06&6    44 layt2i( ) * 3 4 neee $Ifgd2ikdA $$IflF$o t06&6    44 layt2i4 5 6 ? @ neee $Ifgd2ikd $$IflF$o t06&6    44 layt2i@ A B K L neee $Ifgd2ikd $$IflF$o t06&6    44 layt2iL M _ n\$&`#$/Ifgd2ikdZ$$IflF$o t06&6    44 layt2i_ ` f g m n $Ifgd2igdMkd $$Ifl  t 6`644 layt2i xssnlllllllgd>gd}kdo$$Ifl0T  t0644 layt2i $Ifgd2i       : ; A B H Ŷn]nHn)jhQ2h6oCJOJQJU^JaJ hQ2hCJOJQJ^JaJ hQ2h6oCJOJQJ^JaJhCJaJh2ihj)h4^U%j)J h4^OJQJUVnH tH jh4^Uh4^hg@h4^CJOJQJaJhQ6jhQ6Uh>OJQJ hQ<hhhCJOJQJaJ hhCJ OJQJ^JaJ       ^ _ ` a b gd>gd  r D%gd4^ H I J K O P Z [ \ ] ^ _ ` a b ꢙh>OJQJhQ6hhh{;aJ hQ2hCJOJQJ^JaJ%h4^CJOJQJ^JaJmHnHu hQ2h6oCJOJQJ^JaJ%h {CJOJQJ^JaJmHnHu)jhQ2h6oCJOJQJU^JaJ,1h. A!"#$% $$If!vh5] 5O#v] #vO:Vl  t&&&6,5] 5O` &ap&&yt2i$$If!vh5<55J5K5K5K5K#v<#v#vJ#vK:Vl4 t0d&,,5<55J5Kyt2iT$$If!vh5<55J5K5K5K5K#v<#v#vJ#vK:Vl& t0d&,,5<55J5Kyt2iT$$If!vh5<55J5K5K5K5K#v<#v#vJ#vK:Vl& t0d&,,5<55J5Kyt2iT$$If!vh5<55J5K5K5K5K#v<#v#vJ#vK:Vl& t0d&,,5<55J5Kyt2iT$$If!vh5<55J5K5K5K5K#v<#v#vJ#vK:Vl& t0d&,,5<55J5Kyt2iT$$If!vh5555555#v#v#v#v#v#v:Vl t0f&6,,555555ayt2i$$If!vh5555555#v#v#v#v#v#v:Vl t0f&6,,555555ayt2i$$If!vh5555555#v#v#v#v#v#v:Vl t0f&6,,555555ayt2i$$If!vh5555555#v#v#v#v#v#v:Vl t0f&6,555555ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i$$If!vh5o55 #vo#v#v :Vl t06&65o55 ayt2i`$$If!vh5 #v :Vl t 6`65 yt2i$$If!vh55#v#v:Vl t06,55/ / yt2iDd r030  # AbF\T=&io"mn\T=&ioPNG  IHDRnJ}sRGB pHYs.>IDATx^ێ6 D3~aKdUeLR, W+>… <߿MU~yZS(y(Bޞ)#;6`n=Y-YDHeʑ[.׀"X!4"YzaHPFVL!1WYZzi<[EPXEqSrJqq  !"#$%&'()+,-./0125:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root Entry  F0Z7Data *WordDocument .RObjectPool Z0Z_1251715369 FZZOle PRINT9CompObjM  FPBrushPBrushPBrush9qOh+'0  < H T`hpxEVALUATION CRITERIARCH^  Wa=a  =aA n(n8ObjInfo Ole10Native1TableE9SummaryInformation( BMn6(n8      !ia;{7fC;A:={3 +|jOzl"[\t6=jBvr|!jRKCۃ"Q̷LMx% N6k HV("0\xڼRAj,SŞ)DhdfAԨNqutyʹ٢B fƺߎP;\\5~fb٧0Iی>׳P;A.:ҳ󁟵R>`ٺ^߂(F۴ܤº55峧?u䙣<&E{2<+!{|<f/Gh DF(]VjwRʹUQKB RgPՄNW' ?I_++JB_0!ڤ""ֹOooETGZ0e+!\-K"w)ЎgQ8?ޭ[]!~]Gr)*G̬9[Q .*a/@ZaSd! AOJ" ~8FUDn/Ai{ flL;Xnb/ l#d1_*Br LE=XQ>Š(e7G^3f\P]ۙ[XRCU>Ӗ̈́vK6&I$>/N,lUFƟwQқ- g["6+pJϔ)Aߵܝs} l.rxƠDq$v7>AY#DzgacOʬVlg d(b:+E,O^F>\Ep#+,tLҋRjPKpB,ä V);B8L@ a.ä V);B8L@ a.ä V);B8L@ a.ä V);yiFʡIENDB` Normal.dotVanessa Cilia2Microsoft Office Word@@0Z@0Z՜.+,0 hp   Women's and Children's Health EVALUATION CRITERIA TitleDocumentSummaryInformation8 HCompObjq  FMicrosoft Office Word Document MSWordDocWord.Document.89qJ@J {;Normal$a$KHOJQJ_HmH sH tH R@R {; Heading 1$@&a$5:@CJOJQJDAD Default Paragraph FontRi@R  Table Normal4 l4a (k(No List^^ {;Heading 1 Char*5:@CJKHOJQJ_HmH sH tH 6@6 {; Table Grid:V4@4 {;Header  9r 4 @"4 {;Footer  9r ~@3 > Table Grid 1z:V0jj $a$6]6].)A. 6o Page NumberbR  z+-?BO02468:;>J')+-/123@IRTVXZ\]foqsuwyz   '()*3456?@ABKLM_`fgmn^_`c00 0 0 0000000 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 00 0 0 0 0 0 0 000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000000000 0 0 000@000@000@000@000@0@0@0 \z@0@0@0@0@0b1\M00  z+-?BO02468:;>J')+-/123@IRTVXZ\]foqsuwyz   '()*3456?@ABKLM_`fgmn^c0210A0h 0B0e @0@0@ 0@ 0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0@0 @0 @0@0 @0 @0 @0 @0 @0 @0 @0 @0@0 @0 @0 @0 @0 @0 @0 @0 @0@0 @0 @0 @0 @0 @0 @0@0@0@0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0@0@0@0@0@0@0 @0 @0 @0@0@0 @0@0@0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0 @0@0@0 @0 @0@0@0 @0 @0 @0 @0 @0 @0 @0@0@0@0@0@001V010100 00 00 @0 @0 00]00O?000000 00 II H b &(  : > 1 3 \ f y  ( 4 @ L _ b   !"#$%'a 3CEx:!Evaluation_criteriaccAKO]^`cAKO]^`cAKO]^c`cQ6Q2>q?2G8L[4^2i6oy {P{;q  ?B02468:;>')+-/12@IRTVXZ\]foqsuwyz   '()*3456?@ABKLM_`;c@3bP@UnknownGz Times New Roman5Symbol3& z Arial?& Arial Black9Garamond"1hD⹦D⹦!42QHX ?{;2EVALUATION CRITERIARCH Vanessa CiliaRoot Entry  Fl7Data *WordDocument .RObjectPool Z0Z      !5)'  !"#$%&'()+,-./012(:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~ DocumentSummaryInformation8 CompObjq Normal.dotVanessa Cilia2Microsoft Office Word@@0Z@0Z՜.+,D՜.+,\ hp   Women's and Children's Health EVALUATION CRITERIA Title4 $,  FMicrosoft Office Word Document MSWordDocWord.Document.89q