SSI FS 2000:2 Th Swish Rition Prottion Institut s Rgultions on X- ry Dignostis; issu on April 28, 2000. On th sis of 7 of th Rition Prottion Orinn (1988:293) n ftr onsulttion with th Ntionl Bor of Hlth n Wlfr, th Swish Rition Prottion Institut hs issu th following rgultions. 1 1 Ths rgultions r pplil to prtis with ionising rition with rspt to mil n ntl ignostis y mns of trnl rition sours lik -rys or riotiv sustns. Th rgultions r lso pplil to mil or ntl us of suh rition sours for plnning n guin, for rsrh n for lgl n insurn rlt mintions. For ntl prtis with pnormi -ry quipmnt n with -ry quipmnt with mimum tu voltg not ing 75 kilovolts (kv) intn for intr-orl img rptors, 7 is not pplil. 2 Trms n onpts us in th Swish Rition Prottion Institut s rgultions (SSI FS: 2000:1) on gnrl oligtions in mil n ntl prtis using ionising rition hv th sm mning in ths rgultions. 3 In ths rgultions th following onpts r us with th mnings spifi hr: ignosti rfrn os lvl stlish y th Swish Rition Prottion lvl: Institut for rtin typ of mintion whih, if, shll l to msur, ignosti stnr os: thnil msuring protool: spilis mintions in ntl riology: rition os for rtin typ of mintion, onfirm y th lin holr n trmin in th sm wy s pplil for th orrsponing ignosti rfrn lvl, protool tht is st up uring ptn tsts or othr mntory hks, ll prtis within ntl ignosti riology pt pnorm riogrphy of th st of tth, phlogrphy for ntl purpos n intr-orl -ry ignostis. 1 Cf. Counil Dirtiv 97/43/Eurtom of Jun 30, 1997 on hlth prottion of iniviuls ginst th ngrs of ionising rition in rltion to mil posur, n rpling Dirtiv 84/466/Eurtom, OJ L180, July 9, 1997, p.22 (CELEX 397L0043).
Comptn 4 Th riologil lrship for mil prtis with -rys shll hl y rgistr physiin with spilist omptn in on of th isiplins mil riology, nuroriology or pitri n olsn riology. Th riologil lrship for mil prtis with -rys tht r us for guin or os plnning for mil riothrpy my hl y rgistr physiin with spilist omptn in ithr riology or onology. Th riologil lrship for prtis onrning on nsitomtry or othr ignostis using trnl riotiv sours my, ltrntivly, hl y rgistr physiin with spilist omptn in fil tht is rlvnt for th prti. 5 Th riologil lrship for prtis with spilis mintions in ntl -ry ignostis shll hl y rgistr ntist with spilist omptn in ntl -ry ignostis. Th riologil lrship for prtis with ntl pnorm mintions shll hl y rgistr ntist with spil trining for pnorm mintions. Th riologil lrship for prtis with ntl -ry ignostis using quipmnt with mimum tu voltg not ing 75 kv n intn for us of intr-orl img rptors shll hl y rgistr ntist. 6 Th physiin who hols th riologil lrship for mil -ry ignostis shll hv prtiipt in spilist s omptn ours or n quivlnt ours omprising -ry thniqu n rition prottion, or shll hv quir th orrsponing knowlg y othr mns. 7 Th mil physiist n th prson who hols th riologil lrship shll togthr nsur tht th rition is us in n optimis wy tking into ount th mil ojtivs n th rition os to th ptint. Th mil physiist shll th lin-holr s prt on issus onrning rition physis n rition prottion. Th mil physiist shll o-orint th rition prottion tivitis y whih is mnt tht sh/h shll 1 hv lr insight into th riologil prtis of th lin holr, 2 prtiipt in th stlishmnt n onut of qulity ssurn progrmms for oth quipmnt n prours, 3. nsur tht nw mintion mthos r vlut from rition prottion point of viw, 4. hv ling position in ptint os msurmnts n lultions, 5. hv ling position in how mntory hks of quipmnt r prform, 6. prtiipt in invstigtions of unplnn vnts tht r of importn from rition prottion point of viw, 7. prtiipt in th purhsing pross of quipmnt for riologil prtis, 8. pln for n hk th physil rition prottion whn prmiss r nw or ruilt, 9. in onsulttion with th supriors of th prsonnl onrn n th prson holing th riologil lrship, prtiipt in th ution th prsonnl in mttrs of importn from rition prottion point of viw, 10. hv ling position in th sign of routins for iniviul os monitoring of th prsonnl.
8 All prsonnl in th prti shll hv qut ution n to prform th prti in soun wy from rition prottion point of viw. 2 Routins for suh ution shll oumnt in writing in th qulity mnul. Th oumnt shll show whih ution lmnts iffrnt tgoris of prsonnl hv to go through in orr to ntitl to prform rtin work. For prsonnl working routinly with -ry mintions of hilrn, with srning or with lrg os prours lik omput tomogrphy or intrvntionl riology, prtiulr high mns shll rquir for ution. Th prsonnl shll rtify y signtur tht sfty routins n othr ution lmnts hv n gon through. Qulity ssurn 3 9 Th lin-holr shll hv n stlish qulity ssurn progrmm whih ompriss hks of th quipmnt s wll s of th working mthos. All quipmnt shll provi with writtn mtho sriptions ovring th mintions tht r onut thr. Th sriptions shll ompris intr li posur tls n informtion out qut os rution mthos lik omprssion n us of vis for prottion of th gons or th thyroi. Whn pplil, th mtho sriptions shll ontnt ltrntiv prours or mthos for th mintion of prgnnt womn. 10 Fluorosopy tims for intrvntionl prours n for -ry quipmnt us outsi th -ry prtmnt shll ror in logook. 11 Th prson who hols th riologil lrship shll nsur tht womn in hil ring g r sk whthr thy r prgnnt or not for mintions whr th lowr omn is in th primry m r prform. If th womn is prgnnt, or if prgnny nnot lu, th justifition of th mintion n th urgny shll srutinis prtiulrly. Prgnnt womn shll min with suh quipmnt n mthos tht giv rition os to th fotus s low s rsonly hivl. Th sltion shll, howvr, m suh tht th nssry ignosti informtion is otin or othr mil purposs r hiv. Dignosti rfrn lvls 12 Th ignosti stnr os shll trmin for thos mintions for whih th Swish Rition Prottion Institut hs stlish ignosti rfrn lvls. If th ignosti stnr os is ing th ignosti rfrn lvl, th rson for tht shll invstigt n msurs shll tkn s to ru th os. Th rsults from th os msurmnts oring to th first prgrph shll oumnt n, on rqust, snt to th Swish Rition Prottion Institut. 2 Empl for th sign of th ontnt of th ution n trining is givn in th SSI rport 95-12 (1995). 3 Gnrl rgultions for qulity systms r provi in th Ntionl Bor of Hlth n Wlfr s rgultions n gnrl vi (SOSFS 1996:24) on qulity systms in th hlth n mil srvis.
Equipmnt 13 Fluorosopy without img intnsifir or quivlnt thniqu must not us. 14 Nw purhs -ry quipmnt for fluorosopy shll provi with utomti rightnss ontrol with t lst two os lvls. Nw purhs -ry quipmnt shll provi with mns showing th mount of rition tht th quipmnt is mitting uring th mintion, if th quipmnt is intn for omput tomogrphy, intrvntionl riology, ngiogrphy of th trunk, mintion of th igstiv orgns or is to us spilly for th mintion of hilrn. 15 Th quipmnt shll wll pt to th intn us. Equipmnt tht is intn to us minly for srning, mintion of hilrn n for high os prours suh s omput tomogrphy or intrvntionl riology shoul spilly sign for th rsptiv pplition. 16 Equipmnt for ignostis ontining riotiv sustns shll mrk with wrning symol for ionising rition 4 n with informtion out nuli n tivity. Chk of quipmnt 17 An ptn tst shll prform for th first linil us of th quipmnt. Th ptn tst shll t lst ompris ll prmtrs n funtions tht influn img qulity n rition os. 18 Bs lin vlus im to us for omprison for th hks oring to 19 shll stlish in onntion with th ptn tst of th quipmnt or whn th quipmnt ftr livry is rgr to hv n tst n is fr for linil us. Aftr quipmnt or its ssoris hv n sujt to hngs tht my influn th s lin vlus nw s lin vlus shll stlish. 19 Equipmnt n its ssoris shll hk from rition prottion point of viw to t lst th tnt n with th frquny tht is init in Ann 1. Th following is pplil: 1. Tl 1 for hk of mil n ntl -ry quipmnt pt quipmnt for ntl pnorm -ry mintions or quipmnt for ntl -ry ignostis with mimum tu voltg not ing 75 kv intn for intr-orl img rptors, 2. Tl 2 for hk of quipmnt for ntl pnorm -ry ignostis, 3. Tl 3 for hk of quipmnt for ntl -ry ignostis with mimum tu voltg not ing 75 kv intn for intr orl img rptors, n 4. Tl 4 for hk of quipmnt ontining riotiv sustns. In ition, hks shll prform of thos prts or funtions tht might influn y prform srvi msur, for th quipmnt or its ssoris r rought gin into linil us. 4 Th wrning symol for ionising rition is provi in Svnsk Stnr SIS 031210 Bilsymolr för märkning. Th symol is intil to th symol provi in Counil Dirtiv 92/58/EEC of 24 Jun 1992 on th minimum rquirmnts for th provision of sfty n/or hlth signs t work (OJ L 245, 26.8.29, p. 23, Cl 392L0058).
20 A thnil msuring protool shll rwn up n sign for h hk, n kpt for so long tim tht long trm trns of vitions n rvl. 21 Confirm fults shll ttn to. If fults, not implying n ut rition hzr, r not orrt immitly, n tion pln for rtifition shll rwn up inluing tim shul, in whih u ttntion is givn to th rl n potntil onsquns from rition prottion point of viw to whih th fult oul l to. Othr oligtions for th lin holr 22 Holrs of olltiv lins shll vry yr, uring th prio Otor- Novmr, provi th Swish Rition Prottion Institut with n upt list of quipmnt ovr y th lin. Th list shll ontin thos spifitions tht th Swish Rition Prottion Institut is stting. 23 If th lin ompriss mnufturing, th mnufturing is rstrit to th lin-holr s fil of rsponsiility. Mnufturing implis moifition, proution of omponnts tht l to improvmnts n putting togthr prts from iffrnt quipmnt. 24 Trnsfr or ls of quipmnt within th ountry my only on to thos who hv vli lin for possssion n us of suh quipmnt. Sttistil informtion 25 Th lin holr shll, on rqust, sumit to th Swish Rition Prottion Institut informtion onrning numr n typ of -ry mintions s wll s rition oss to ptints tht hv unrgon iffrnt typs of mintions. Eptions 26 If prtiulr grouns ist, th Swish Rition Prottion Institut my grnt ptions from ths rgultions. Ths rgultions ntr into for on July 1, 2000, whn th Swish Rition Prottion Institut s rgultions (SSI FS 1981:4) on hk of quipmnt for -ry ignosis shll s to pply. Howvr, th stion 12 shll not pply until th Swish Rition Prottion Institut hs issu rgultions on ignosti rfrn lvls in its o of sttuts. On hlf of th Bor of th Swish Rition Prottion Institut LARS-ERIK HOLM Wolfrm Litz
Ann 1 Tl 1 Chks with rspt to mil n ntl -ry quipmnt with th ption of ntl pnorm -ry quipmnt n ntl quipmnt with mimum tu voltg not ing 75 kv intn for intr-orl img rptors Frquny of hks nnu wkly ily l 1 X-ry systm f g Funtion of th posur swith n funtion of th rition initor n th fluorosopy timr Agrmnt twn init n rl tu voltg Rltionship twn os (mgy) n init tu loing (mas) Th pr-slt os of th utomti posur systm n its rprouiility Filtrtion of th rition m in front of th ptint Agrmnt in siz n position twn intn n rl rition fil Funtion of th omprssion vi 2 Img rptor systm f g Sptil rsolution Snsitivity Conformity of snsitivity of imging systms of th sm typ Homognity n sn of rtfts Mhnil funtion of th -ry sstts Cntring, funtion n onition of th ntisttr gri Contrst n rsolution of monitors 3 X-ry stns Mhnil stility of th stn Conition of rition shils inluing th fstning vis 4 Aitionl for CT-snnrs Ajustmnt of th rition fil to th slt sli thiknss, ttor prtur n init sli position Nois lvl s funtion of tu loing (mas) for som linil rlvnt sttings Agrmnt twn slt n rl movmnt of th ptint tl Wight CTDI-vlu 5) for ommonly us linil sttings. Homognity to ontinu 5) Dfinition of th wight CTDI-vlu is givn.g. in th Swish stnr SS-EN 60601-2-44.
Tl 1 (ontinution) Ann 1 5 Furthr hks Th ontnt n ssiility of th instrution for us Mrking n funtion of th ontrols Gon prottion vis - ssiility n funtion Prsonl n fi prottion vis - ssiility n funtion Film prossing - onstny 6 In ition for quipmnt for mmmogrphy Rfrn os with stnr phntom Low ontrst rsolution Film prossing - onstny Automti posur ontrol - Constny with rspt to tu loing n film nsity Tl 2 Dntl pnorm -ry quipmnt Frquny of hks nnul wkly ily 1X-ry systm Funtion of th posur ontrol Agrmnt twn rl n init tu voltg Filtrtion of th rition m in front of th ptint Agrmnt twn th rl n intn vlus of th position n th siz of th rition m. Th intnsity of th rition m s funtion of th position uring th tomogrphi movmnt. 2 Img rptor systm Gomtril rsolution Conformity of th snsitivity of imging systms of th sm typ Homognity n sn of rtfts Mhnil funtion of film sstts Monitors - ontrst n rsolution 3 X-ry stn Mhnil stility of th stn 4 Furthr hks Assiility of th instrution for us Mrking n funtion of th ontrols Film prossing - onstny
Ann 1 Tl 3 Dntl -ry quipmnt with mimum tu voltg not ing 75 kv intn for intr-orl img rptors Frquny of hks nnul wkly ily 1 X-ry systm Prsn of th filtr in th primry m Mrking n funtion of th ontrols Funtion of th posur inition Agrmnt of position n siz twn th rition fil n th prtur of th positioning vi 2 Furthr hks Rition prottion vis for ptints (suh s thyroi shils) prsn n onition Assiility of th instrutions for us Rviw of th film prossing prour Film prossing Tl 4 Equipmnt for ignosti with trnl rition sours onsisting of riotiv sustns Frquny of hks Funtioning of th shuttr Lkg hk of th rition sour Chk of th mrkings Dttor systm Annully n ftr hnging th rition sour