BS 6196-1989 Specification for sterile epidural catheters and introducer needles for single use《一次使用的无菌硬膜外导管及导引器针头规范》.pdf

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1、BRITISH STANDARD BS 6 196 : 1989I n c orpora t ingA mendmen t N o. 1S pec ificat ion forS t erile epidu r a lcat het ers a ndint rodu c er needles fors ingle us eUDC 61 6 072. 2 : 6 1 6 0 89.84 7 : 001.4: 006. 3/.8: 620.1Confirmed November 2011BS 6 196 : 1989T his B rit i s h S t a nda rd, h a v ing

2、b eenprepa red under thedirec t ionof theH e a l t h CareS t a nda rds P olic y C ommittee,w a s p u b lis hed under thea uthority of the B o a rdof BSIa ndc omes int oeffec t on3 1 J u l y 1989 BSI 11-1999F irst p u b lis hed F e b r u a r y 1982F irst rev i s ion J u l y 1989T hefollow ing BSI ref

3、erenc e s rela t e to the workon this sta nda rd:C ommitteereferen c e HCC/27D r a f t forc omment 8 7/553 15 DCISBN 0 580 1 7 148 5C ommittees res pons i b le for this B rit i s h S t a nda rdT heprepa r a t ionof this B rit i s h S t a nda rd wa s ent r ustedb y t heH e a l t h CareS t a nda rds P

4、 oli c y C ommittee( HCC / -) to T e c hni cal C ommitteeHCC/27, uponw hic h thefollow ingb odies w ererepres ent ed:A sso c i a t ionforM edical P h ysi c s T e c hnologyA sso c i a t ionofA n a e sthet i sts ofG rea t B rit a ina ndI rela ndA sso c i a t ionofC linical Pat hologistsB rit i s h D i

5、et e t i cAsso c i a t ion( PENG )B rit i s h H e a l t h-CareT r a dea ndI ndust r y C o u n c ilB rit i s h I n sti tuteof RadiologyB rit i s h Paedi a t ricAsso c i a t ionB rit i s h P l a sti c s F edera t ionB rit i s h R u bberMan u f acturer s A sso c i a t ionB rit i s h S u rgical T r a de

6、s A sso c i a t ion I n c orpora t edC ollegeofRadiogr a phersD epa r t ment ofH e a l t h a nd S o c i a l S e c u rityD i s pos ableH y podermicandA lliedE q u ipment Man u f acturers A sso c i a t ion( UK)I n t ens i v e CareS o c ietyMal a ysi a n R u bberP rodu c ers R e s e a r c h A sso c i a

7、 t ionM edical S t erileP rodu c ts A sso c i a t ionNat iona l A sso c i a t ionofT hea t reN u r s e sP h a rmace uti cal S o c iety ofG rea t B rit a inR o y a l C ollegeofRadiologistsR o y a l C ollegeofS u rgeons ofE ngla ndC oopt edmemb ersA mendments i ssued sinc epu b licat ionA md. N o. Dat

8、 eofissu e C omments6 458 N o v emb er1990I ndi cat edb y a sidelinein them a rginBS 6 196 : 1989 BSI 11-1999 iC ont entsPageC ommittees res pons i b le I n s idefront c o v erF ore w ordiiS e c t ion1.G enera l1 Scope 12 D efinit ions 13 F inis h14 F reedomfromb iologicalha z a rd 15 Pack a ging 16

9、 Marking 2S e c t ion 2. S t erileepidu r a l cat het ers a ndcat het er stylets7 Cat het er 38 Cat het er stylet3S e c t ion 3. S t erileepidu r a lin t rodu c erneedles a ndneedle stylets9 E pidu r a lin t rodu c erneedle 51 0 E pidu r a lin t rodu c erneedle stylet 5A ppendix AGu ida n c efordes

10、igna ndm a t eria l s7A ppendix BSy m b olfor single use 7A ppendix CMe t hodof te st fordet ermining thestrengt hof unionb e tweencat het era ndnon-det ach ableh u b 7A ppendix DMe t hods of t e st fordet ermining thes e c u rity of unionb e tweencat het era nddet ach ableh u bandb e tweencat het e

11、r sty let a ndb utt on 8A ppendi x EMe t hodof te st forc orros ionres i sta n c e8A ppendix FMe t hods of t e st fordet ermining thes e c u rity of unionb e tweenepidu r a lin t rodu c erneedlea ndh u bandb e tweenepid u r a lin t rodu c erneedle styleta nd b utt on 9A ppendix GMe t hodof te st for

12、d u llness ofpoint ofepidu r a lin t rod u c erneedle 9F igu re1E pidu r a l cat het er 4F igu re 2 E pid u r a lin t rod u c erneedlea nd stylet6F igu re 3 ISO sym b ol“ D ono t re-use”, registr a t ionn u m b erISO 7000/1 0 51 7P u b licat ions referred to I n s ideback c o v erBS 6 196 : 1989ii B

13、SI11-1999F orew ordT his first rev i s ionofBS 6 196 w a s prepa red under thedirec t ionof theH e a l t h CareS t a nda rds P oli c y C ommittee.BS 6 196 w a s first p u b lis hedin1982 a nd wa s prepa reda t t herequ e st of theD epa r t men t ofH e a l t h a ndS o c i a l S e c u rity.T hem a ind

14、ifferenc e s from the1982 edit ion, whic his now w i t hdra w n ,area s follo ws.a ) R equ irements forfreedomfromb iologicalha z a rda reint rodu c ed.b ) T heminimu mlengt hof theepidu r a l cat het eri s not s pec ified, so a s t o a llow s hor t ercat het ers for spec i a liz eda pplicat ions su

15、c h a s p a edia t ric us e.H o w e v er,i t i s stillre c ogni z ed th a t epidu r a l cat het ers fora d u l t use shou ldb e a t lea st 9 00 mminlengt h.c ) A ddi t ion a ldi sta n c ema rks on theepidu r a l cat het era reint rodu c eda t t hereq u e st ofc linic i a n s , whofind them usefu lin

16、fine a djust men t of thee xtent ofcat het erins ert ion. A sepa r a t e syst emofdista n c ema rkingis int rod u c edforcat het ers forp a edia t ric us e.d)A fix edlengt hfor theepidu r a lin t rodu c erneedlei s not spec ified, so a s topermi t ,at t herequ e st ofc linic i a n s ,ar a ngeoflengt

17、 h s (inm u l t iples of1 0 mm)forp a r t i c u l a r a pplicat ions suc h a s p a edia t ric useor useinob e s epa t ients.T hec ommi tteeres pon s i b lefor this sta nda rdh a s not fou ndi t pract i cable tos pec ify c rit eri a forrigidity orres i sta n c e tokinking,coilingorknotting, nor tos p

18、ec ify p a r t i c u l a rma t eri a l s w i t h thes e c h a r act eristi c s . H o w e v er, des igng u ida n c ei s giv eninA ppendix A .I t h a s not y e t b eenfou ndpossi b le to s pec ify a sa t i s f act ory met hodofmea suringr a dio-opaci ty. H o w e v er, thep ack a gingofepidu r a l cat

19、het ers t h a t a rem a deofm a t eria l whic his inherent l y r a dio-opa q u e , or to whic h a r a dio-opacify inga gent h a s b eena dmix ed, i s to b ema rked“RADIO - OPAQUE”.S ingle-useepidu r a leq u ipment s hou ldb ema n u f actureda nd st eriliz edinaccorda n c e wi t h therec ommenda t io

20、ns in the“ G u ide to G oodMan u f acturingP r act i c eforS t erile M edical D e v i c e s a ndS u rgical P rodu c ts” 1). A ttent ioni s a l s odra w n to theMan u f acturers R egi str a t ionSchemea dministeredb y theD epa r t ment ofH e a l t h a ndS o c i a l S e c u rity.S ingle-useepid u r a

21、leq u ipmen t s hou ldnev erb ere used, nor su b jec t ed to a n y f u r t her st eriliz a t ionproc e ss b efore us e.WARNINGNOTE. A ttent ioni s p a r t i c u l a rly dra w n to thed a ngerofp u llingback thecat het er throu ght heepid u r a lin t rodu c erneedle( s eec l a use 6 ) b e causeonocca

22、s ions a piec eof thecat het erh a s b eens e v ered a ndleft in theepidu r a l sp ace.D u e c ogniz a n c e shou ldb e ta kenof this possi b ility whena sse ssingc omp a t i b ili ty ofm a t eria l s ofc onstr u c t ion wi t hhu m a n ti ssue.P rodu c t c ert ificat ion. U s ers of this B rit i s h

23、 S t a nda rda rea d v i s ed to c ons ider thedes irability of thirdp a r ty c ert ificat ionofprodu c t c onformity wi t h this B rit i s hS t a nda rdbas edon t e stinga ndc ont inu ing sur v eill a n c e , w hic hma y b e c o u pledw i t h a sse ssment ofa suppliers q u a lity systems a g a inst

24、 thea ppropria t e Par t ofBS5 7 5 0 .E nqu iries a s to t hea v a ilability of thirdp a r ty c ert ificat ion sc hemes w illb eforw a rdedb y BSI to theA sso c i a t ionof C ert ifi cat ionB odies . I f a thirdp a r tyc ert ificat ion sc hemedoes not a lrea d y e x i st, us ers s hou ldc ons idera

25、pproachinga na ppropria t e b ody from thelist ofA sso c i a t ionmemb ers .1)P u b lis hedb y t heD epa r t ment ofH e a l t h a ndS o c i a l S e c u rity a nda v a ilablefromHMSO,49H ighH olb orn ,London ,WC 1.( ISBN 0 11 320770 0 ).BS 6 196 : 1989 BSI11-1999 iiiABrit i s h S t a nda rddoes not p

26、 u rport toin c l u dea ll thenec e ssa r y prov i s ions ofac ont r act . U s ers ofB rit i s h S t a nda rds a reres pons i b lefor theirc orrec t a pplicat ion.C omplia n c e w i t h aBrit i s h S t a nda rd does not of i tself c onfer immu nity from lega lob liga t ions .S u mma r y of p a gesT

27、his doc u ment c ompris e s a front c o v er,anin s idefront c o v er, p a ges i toiv ,p a ges 1 t o10 ,anin s ideback c o v era ndaback c o v er.T his sta nda rdh a s b een upda t ed( s eec opy right d a t e)a ndm a y h a v eha da mendments inc orpora t ed.T his w illb eindicat edin thea mendment t

28、 ableon theins idefront c o v er.i v b l a nkBS 6 196 : 1989 BSI 11-1999 1S e c t ion 1. G enera l1 ScopeT his B rit i s h S t a nda rd spec ifies bas i c requ irements,inc l u dingrequ irements forpack a ging, forepidu r a lcat het ers a ndepidu r a lin t rodu c erneedles w hic h a resupplied st er

29、ilefor single us e.NOTE1 E q u ipment m a y b e supplied sepa r a t ely or t oget herina nepidu r a l se t .NOTE 2 T he ti t les of thep u b licat ions referred toin this sta nda rda regiv enon theins ide back c o v er.NOTE 3 A ppendix A giv e s g u ida n c eonde s igna ndm a t eria l s ,a ndA ppend

30、ix G su ggests a met hodof te st for thed u llness of theepidu r a lin t rod u c erneedlepoint .2 D efinit ionsF or thep u rpos eof this B rit i s h S t a nda rd, thefollow ingdefinit ion s a pply .2 .1epidu r a l cat het erfle x i b le tu b ede s igned toin t rod u c eliqu ids int o theepidu r a l

31、sp ace2 . 2 epidu r a l cat het er styletdev i c e to a ssi st theins ert ionof thecat het er2 . 3 p a t ien t endt h a t endof thecat het er whic his int rodu c edint o theepidu r a l sp ace2 .4free endt h a t endof thecat het er whic hrema ins e xterna l tot hep a t ient2 .5e y eopeningb e tween t

32、heins idea nd theo utsideof thecat het er2 . 6 h u bc omponent a t t hefreeendof thecat het erorepidu r a lint rodu c erneedleinc orpora t ing aconi calfema let a per2 . 7 epidu r a lin t rod u c er needlerigidme t a l tub eof su i t ablelengt h toen able theint rod u c t ionof a nepidu r a l cat he

33、t erint o theepidu r a l s p ace.I t inc l u des a h u banda formedendw hic hma y ,by n a tureofi ts c onfigu r a t ion,assi st t hedeflec t ionof thecat het er. A nepid u r a lin t rod u c erneedle stylet i s a l w a ys prov ided2 .8epidu r a lin t rodu c er needle styletdev i c e tooccl u de theep

34、idu r a lin t rodu c erneedled u ringins ert ion2 .9epidu r a l se ta nepidu r a l cat het era ndoneormorea n c illa r y dev i c e s p ack a gedin the s a me unit c ont a inerNOTE C omponents ofa ty picalepidu r a l se t for single us e a reillustr a t edinF igu re1 a ndF igu re 2, whic hin c l u de

35、 terms used todes c rib e c omponent p a r ts.3 F inis hW hene x a minedb y norma lor c orrec t ed vi s ionw i t houtm a gnifi cat ion ,allc omponents sh a lla ppe a rs moo t h a ndfreefromfla s h , surfaceirregu l a rit ies ,mou ldinga nde xtr usiondefec ts.W hene x a mined under 2.5m a gnificat io

36、n thec omponents s h a lla ppea rfreefrome xtr a neous m a tter.4 F reedom from b iologicalha z a rdW hen te stedin theirfina lform,af t er st eriliz a t ion,inaccorda n c e wi t h t heprinc iples a ndmet hods rec ommendedin BS5 736 , epidu r a l cat het ers a ndepidu r a lin t rodu c erneedles sh a

37、 llb e a sse sseda s b eingfreefromb iologicalha z a rd.5 Pack a ging5.1 G enera lEachepidu r a l cat het er, epidu r a lin t rodu c erneedle,orepidu r a l se t s h a llb e se a ledina unit c ont a iner.O neormore unit c ont a iners s h a llb epackedint o a no uterc ont a iner.5.2 U nit c ont a iner

38、sT he unit c ont a iner sh a llpermit steriliz a t ionof thec ont ents in si tu. I t sh a llensurem a int ena n c eofsterility a ndprov ideprot e c t ionof thec ont ents d u ringh a ndling, tr a n s i t a nd st ora ge.T he unit c ont a iner sh a llb e sode s igneda s t opermit t heprodu c t t o b ep

39、res ent edfor us ein a n a s ept i cm a nner.NOTE O n c e the unit c ont a inerh a s b eenopenedi t s hou ldnot b epossi b le tore s e a lit e a s ily a ndi t s hou ldc lea rly rev e a l th a t i t h a s b eenopened. U nit c ont a iners s hou ldb e st oredin theiro uterc ont a iners inc ool, dry , d

40、 a rk, rea s onabl y d ust-freec ondit ions a ndnot e x pos ed toioniz ingr a dia t ion.BS 6 196 : 19892 BSI11-19996 Marking6 .1 U nit c ont a inersU nit c ont a iners forepidu r a l cat het ers , epidu r a lint rodu c erneedles orepidu r a l se ts s h a llb ema rkedw i t h , or sh a lldis pla y ona

41、 nin s ert , thefollow inginforma t ion.a ) D e s c ript ionofc ont ents inc l u ding:1) thedes igna t ed si z ein accorda n c e wi t h 7 .1or 9.1,as a ppropria t e ;2 ) whet herforp a edia t ric us e ;3 ) thedista n c eindicat orm a rking system;4)for a nepid u r a lin t rod u c erneedlep ackeds ep

42、a r a t ely , the si z eof thecat het erfor whic hit i s int ended.b ) T he word“ STERILE”.c ) T he words “ FOR SINGLE USE”oreq u i v a lent .NOTE T he sym b oldes c rib edinA ppendix B m a y a l s o b es how n.d)A wa rninga g a inst useof thedev i c eif thep ack a gei s openord a m a ged.e)A promin

43、ent w a rningno t i c ein thel abellingonp ack s ofepidu r a l cat het ers a ndonepidu r a l se ts,rea dinga s follo ws:“ CAUTION: N e v erp u llback thecat het ert hro u gh theepidu r a lin t rodu c erneedle.”f)T he word“RADIO- OPAQUE ” , ifa ppropria t e.NOTE T he word“ RADIO- OPAQUE”only implies

44、t hea ddi t ionof a r a dio-opacify ingmedi u m to theepidu r a l cat het erm a t eria lor the useof a ninherent l y r a dio-opa q u ema t eria l ,b o t h wi t h theint ent ionofrendering theepidu r a l cat het eropa q u e to X -ra ys.g)T hebat c hnu m b era ndd a t eofma n u f acture, oraba t c hnu

45、 m b erfrom whic h thed a t eofm a n u f acture(mont h a nd ye a r)m a y b edet ermined.h)T hen a mea nd/ orregistered tr a dem a rkof them a n u f actureror su pplier.i)T hen u m b erof this B rit i s h S t a nda rd,i.e.BS 6 196 2 ).6 . 2 O uter c ont a iner or c ont a inersT heo uterc ont a ineror

46、c ont a iners s h a llb ema rkedw i t h thefollow inginforma t ion.a ) D e s c rip t ionofc ont ents s ee 6 .1 a ) .b ) T he word“ STERILE”.c ) T he word s “ FORSINGLEUSE”oreq u i v a len t .NOTE T he sy m b oldes c rib edin A ppendix B m a y a l s o b es how n.d)T he word“ RADIO- OPAQUE” , ifa ppro

47、pria t e s eeN o t e to 6 .1 f) .e)T hen a mea nda ddress of them a n u f acturera nd/ or su pplier.f)T hed a t eof steriliz a t ion(mont h a nd ye a r).g)T he bat c hnu m b era ndd a t eofma n u f acture s ee 6 .1 g) .h)T hen u m b erof this B rit i s h S t a nda rd,i.e.BS 6 196 2 ).2 ) MarkingBS 6

48、 196 onorinrela t ion to a produ c t repres ents a m a n u f acturers dec l a r a t ionofc onformity, i.e.acl a imb y oronb eha lfof them a n u f acturer th a t t heprodu c t meets t herequ irements of the st a nda rd.T heaccu r acy of thec l a imi s t herefore solely t heres pons i b ility of t hep

49、ers onm a king thec l a im.S u c h a dec l a r a t ioni s not t o b e c onfused wi t h t hirdp a r ty c ert ificat ionofc onformity, whic hma y a l s o b ede s irable.BS 6 196 : 1989 BSI 11-1999 3S e c t ion 2. S t erile epidu r a l cat het ers a nd cat het erstylets7 Cat het er7 .1 S i z ede s igna t ionT he si z eofepidu r a l cat het ers s h a llb ede s igna t edb y t hefollo w ing.a ) O utsidedia met erof thecat het ere x pressedinmillimet res to thenea rest 0 .1mm.b ) E ffec t i v elengt hof thecat het er, e x c l u dingh u ba ssemb l y , e x pressedin