TCVN TIEU CHUAN QUOC GIA TCVN 10070:2013 EN 14372:2004 Xudt ban fan 4 BO DUNG TRE EM - THiA, DIA VA DUNG CU AN - YEU CAU AN TOAN VA PHUONG PHAP THU’ Child use and care articles —Cutlery and feeding utensils — Safety requirements and tests HA NOI -2013TCVN 10070:2013 Loi noi dau TCVN 10070:2013 hoan toan tong dong voi EN 14372:2004 TCVN 10070:2013 do Tiéu Ban ky thuat tiéu chudn quéc gia TCVN/TC 181/SC 1 86 ding tré em bién soan, Téng cyc Tiéu chudn Bo luong Chat lugng dé nghi, Bé Khoa hoc va Céng nghé céng bé.TCVN 10070:2013 Lai gidi thigu Tiéu chuan nay thiét lp cdc yéu cu an toan tdi thiéu va qui inh phuong phap thr phi: hop cho thia, dia va dung cy An danh cho tré. Thia, dia va dung cu an cila tr duoc sir dung boi ngudi cham séc cho tré dn hode é tré ty’ sir dyng, tir dé tudi trung binh tle 6 thang dén 3 tudi. Tré trén 3 tudi thudng sir dung thém cathia, dia va dung cu &n cla ngudi lon. Do dé, tiéu chudn nay qui dinh cac nguy co tiém 4n phat sinh tir viéc si dung thia, dia va dung cy dn duge thiét ké cho tré tty 3 tudi tré xudng str dung ki 06 hoc khng c6 sy giém sat cla cha me Tuy nhién, tiéu chudn nay khéng loai triy dug tat ca cc nguy co tiém An cho trétir 3 tudi tro’ xuéng siv dyng cac san phdm nhu vay va do dé, viéc kiém soat cia cha me hodc ngudi giam hé la hét strc quan trong. Bigu co ban ld nha san xudt phai dua ra céc canh béo va huéng dn 5 rang duge qui dinh trong tiéu chun nay, cho phép khdch hang bao dam vic sir dyng sn phdm dung cach va an toan. Nguy co’ dang ké do ngat cé thé phat sinh néu chi tiét thia, dia va dung cy an bi tach rdi khi str dung. Nguy co nay dug néu trong tiéu chudn nay & phan cac phép thy an toan. Tiéu chuan nay cing dua ra cdc nguy co tiém dn phat sinh tl viéc gidi phéng mét hay nhidu chat, voi lung chat 6 thé gay nguy hiém cho svc khée ti vat ligu duge sir dung dé lam thia, dia va dung cy an, Khuyén nghi nha san xudt va nha cung cdp thy hién TCVN ISO 9001 d6i voi hé théng quan ly chat lugng.TIEU CHUAN QUOC GIA TCVN 10070:2013 Dé dung tré em - Thia, dia va dung cy an — Yéu cau an toan va phuong phap thir Child use and care articles — Cutlery and feeding utensils — Safety requirements and tests 41 Pham vi 4p dyng Tiéu chudn nay qui dinh cdc yéu cau an toan lién quan dén vat ligu, két cdu, dac tinh, bao géi va ghi nhanthia, dia va dung cy an. Tt cd cac sadn phdm su dyng 8 &n danh cho tré tir 36 thang tro xuéng 6 thé ty an hodc cé tro qui dinh cho cac sain phdm c6 chire nang co’ ban khac, nhung é chire nang phy cho phép tré sir dung san pham dé ty an hod 6 tre gidp ctia ngudi khac. ip cla nguoi khéc thudc pham vi cia tiéu chudn nay. Tiéu chudn nay ofing Tiéu chuan khéng 4p dung cho hép dyng thirc &n 4& so’ ché, hod thia, dia va dung cy an duge thiét ké cho cc ng dyng y hoc dac biét hoac duge sir dung dudi sy giém sat y khoa. Tigu chudn bao gém cac phuong phédp thir déi vi cdc yéu cau co hoc va héa hoc duge qui dinh va cdc yéu cau lién quan dén huéng dan stv dung. Mét sé san phdm dugc thiét ké nh d8 choi hoc cé cdc dac trung giéng dd choi, thi cc san pham nay phai dap ting thém véi cdc yéu cau lién quan cilia TCVN 6238 (EN 71). Tiéu chuan nay khéng 4p dung cho dung cu udng (binh 4n, num ty, voi rét va tach chén) 42 dugc qui dinh boi EN 14350-1 va EN 14350-2. 2 Tailigu vign dan Cac tai liu vién dan sau rat can thiét cho viéc 4p dung tiéu chudn nay. B4i voi cdc tai ligu vin dan ghi nam céng bé thi 4p dung phién ban duge néu. 86i voi cdc tai ligu vién dln khong ghi nam céng bé thi Ap dung phién ban m6i nhat bao gdm ca céc sira ddi, bd sung (néu C6). TCVN 6238-1:2001 (EN 71-1:1988)', An toan dé choi tr em — Phan 1: Yéu cau co'ly, * Tigu chudn nay hién 48 bj hiy va thay thé bang tiéu chudn TCVN 6238-1:2011 (ISO 8124-1:2009).TCVN 10070:2013 TCVN 6238-3:1997 (EN 71-3:1994)7, An toan dé choi tré em - Phan 3: Yéu cdu mie gidi han xém nhép cila cdc d6c t6; EN 1811, Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin(Phuong phap thir d6i ching déi véi sy gidi phéng niken tir tat od cdc khéi xuyén qua co thé va cae chi tiét tiép xtc tryc tiép va lau dai vei da). EN 1SO 2409, Paints and varnishes - Cross-cut test (Son va véc ni - thir nghigm oat ngang); EN ISO 4614, Plastics - Melamine-formaldehyde mouldings - Determination of extractable formaldehyde (Khuén ép chat déo - melamin - formaldehyt - Xac dinh formaldehyt chiét dugc). 3. Thuat ngi va dinh nghia Trong tiéu chudn nay sir dung céc thuat ngd va dinh nghfa sau 34 Thia, dia(cutlery) Dung cy duge sir dyng 48 an nhu dao, dia, thia va dyng cy day thire an. 32 Dung cy n (feeding utensils) Dyng cy hoc vat chira duge str dung cho tré an nhu dia va bat. 33 ‘Dé hiit(suction pad) Chi tiét ca dung cy an ding 48 dan hoac gitr chat dung cy vao bé mat. 4 Viduvé thia, dia va dung cy an Vi dy v8 thia, dia va dyng cy an duge minh hga trong Hinh 1, 2 va 3. ? Tiéu chudn nay hign da bi hiy va thay thé bang tigu chudn TCVN 6238-3:2011 (ISO 8124-3:2010). 6TCVN 10070:2013 CHU DAN A Thia B Dia © Dao D1 Dung cy day thire an - hinh chiéu bang D2 Dyng cy day thie an - chiéu dong DS Dyng oy day thie n - hinh chigu canh Hinh 1 - Vi du vé thia, diaTCVN 10070:2013 (O B2 —T Al BI C2 GB 02 I _F a CHU DAN At Bat-hinh chiéu canh A2 Bat hinh chiéu bing B1 Bia hinh chiéu canh B2 Bia hinh chiéu bing C1 Ba gid nhigt - hinh chiéu canh C2 Ba gitr nhigt- hin chiéu bang C3 Nat thao ri trén dra gic niet D1 Bat 66 voi - hinh chiéu canh D2 Bat c6 véi- hinh chiéu bang Hinh 2 - Vi dy vé dung cy anTCVN 10070:2013 tt) B3 A2 B2 ed At BI CHU DAN Al Dung cy an o6 dem hat A2 Dung cy én - hinh chiéu bing B1 Dem hit - hinh chiéu canh 82 Em hit—hinh chiéu bing B3 Demhit co tal Hinh 3 - Vi du vé dung cu an c6 dém hut tach rei 5 Yéu cau 5.1 Qui dinh chung Cac vat ligu cdu thanh phai phir hop véi cdc yéu cau cilia tiéu chudn nay. $.2 Yéu cau chung 5.2.1. Kiém tra bang mat thuéng va tiép xuc Tat ca cc chi tiét cuia thia, dia va dung cu an khi duigc lp rap dé sir dung phai khéng cé dau nhon va mép c6 thé gay tén thuong. Cac chi tiét nay phai khong bi swt mé, cd ge sac va bavia. 5.2.2. Daunhon Céc dau tiép xtc duge phai khéng Ia dau nhon nh duge xac dinh trong 6.2.1TCVN 10070:2013 5.2.3 Mép sic Cac mép tiép xtic duc phai khong la mép séc nhu duge xae dinh trong 6.2.2. §.2.4 Cac chi tiét nho Khi dua vao éng try thi cdc chi tiétnhd (xem Hinh 4), phai khong cé chi tiét nao lot hoan toan vao éng try thir theo bat ky huéng nao khi khong duge ép. Kich thu6e tinh bang milimet Vdd Hinh 4 - Ong tru thi céc chi tiét nho 5.2.5 6 (kep ngén tay) 4 tranh kep ngén tay, phai khéng cé I6 tiép xtic duoc ma 06 thé cho que 6 duéng kinh 5,5 mm lot qua, trip khi 16 tiép xc dugc cling cho que cé duéng kinh 12 mm I9t quahoac c6 46 séunhé hon 10 mm. Yéu cau nay chi ap dung cho cac chi tiét duge lam tir cae vat ligu 66 d6 cing Shore A lan hon 60 IRHDs. CHUTHICH LB hinn tren khéng dap tng Guge céc yeu clu nay €6 thélam han ché sy Iuu théag mau. Cung nhu vay. nn trénh 8c 18 khong pha a hinh ton c6 g6e se hinh cho V nhgn hode gBe nhon chya dure lam tr tt 5.2.6 Hinh trang tri dwgc in Khi duge thir theo EN ISO 2409, phai khéng ¢6 hinh trang tri dugcin bi ri ra khdi san phdm. 10TCVN 10070:2013 Nhan dan khéng duge sir dung. 53 Yéu clu cohge 5.3.1 D6 bén kéo Tat cA cdc san phdm cé nhiéu hon mét chi tiét va dug tré cAm phai dug thir theo 6.2.3. Khéng duge C6 chi tiét nao bj vo, rch hoac tach réitrong qua trinh thir. 5.3.2 Thiv xoan Néu chi tiét c6 thé duge kep gitta ngén cai va ngén trd, thi phai thir xodn theo TCVN 6239-1 (EN 71-1). Khdng duge cé chi tiét nado bi v6, rach, hod bi tach réi trong qua trinh tha. 5.3.3 96 bén xé Cac chi tiét dugc lam tir vat igu 6 d6 clmg Shore A nhé hon 60 IRHDs, trix dém hut phai due thir theo 6.2.4. Cac chi tiét nay phai khong bi vo, rch hodc tach réi trong qua trinh thir kéo tiép theo. 5.3.4 86 bén/d6 cing Khi duge thir theo 6.2.5, phai khdng chi tiét nao cia thia, dia bj vé, rach hode tach roi. 5.3.5 Thi roi Tat ca céc san phdm phai dug thir roi theo TCVN 6238-1 (EN 71-1). Néu san phdm bi v6, phai dua ra anh bao theo 7.4. 5.4 Yéu cau héa hgc 5.4.1 Qui dinh chung Vat ligu duc sir dung d8 sén xudt thia, dia va dung cy &n phai dug thts theo ligt ké trong Bang 1 va phai phi hyp voi 5.4.2. 5.4.2. Tinh chat hoa hoc 5.4.2.1 Yéu cau cho vat ligu ‘Vat ligu duge st’ dung trong sdn xudt cdc chi tiét cla thia, dia va dung cy an phai due thir voi ca phép thir duge danh dau x trong Bang 1. "TCVN 10070:2013 Bang 1 - Cac phép thirduge tin hanh trén vat ligu Vat ligu Phép thir Théi nhiém | Ham lugng | Ham lwgng | Formaldehyt Niken Bisphenol A cilamétsé | phtalat | chat bay | gidi phéng phéng | gidi phéng | nguyén t6 hoi | | (em 6.3.1)_| (xem 6.3.2) | (xem 6.3.3) | (xem 6.3.4) | (xem6.3.5) | (xem 6.3.6) Cao su silicon x x [Vat liga dan hor niet x | déo Thay tinh, gém, thay x | tinh-gém, men thy tinh | va men khac | | Vat iu niet do x x x [Chat déo xir iy nbiet | x x [Kim Toaithop kim x x | | oe 7% x ("Chi vat ligu nhiét déo 06 chiva polycacbonat hoac polysulfon phai dugc thi gidi phang Bisphenol A. 5.4.2.2 Thdi nhiém cia mét sé nguyén td Khi duge thir theo 6.3.1, sy théi nhiém cua tat cd cde nguyén té tir cdc vat ligu duc sir dung dé san xuat thia, dia va dung cy &n khong duge vet qua giéi han duge néu trong Bang 2. Khi cc chi tiét ca thia, dia va dung cy anduge san xudt tt cac vat ligu khac nhau, hodc mau séc khdc nhau, thi tizng chi tiét nay phai urge thir riéng ré. Phan trang tri phai duc xem la mét phan olla vat ligu néu dugc in vao hiém cua cc nguyén té Gidi han ] Antimon, Sb_ 15 Arsen, As 10 Bari, Ba 100 Cadmi, Cd 20 Chi, Po 25 | ‘Crom, Cr 10, Thy ngan, Ho 10 Selen, Se 100 CHU THICH Phuong php phan tich dugc qui dinh trong TCVN 6238-3 (EN 71-3) dugc dp dung trong iu chun nay co thi, ca vd dung cy Bn. Giothan ee da tn gti hen phlRin cba tm nauyen 6 bg st dung KF thud phn ich tong turn. 12TCVN 10070:2013 5.4.2.3 Ham lvgng phtalat Khi cac chi tiét nhiét déo cua thia, dia va dung cy an dug thi? theo 6.3.2, tng ham Iugng phtalat qui inh khéng dugc vugt qua 0,1 % (mim). 5.4.2.4 Ham lwong chat bay hoi Khi cdc chi tiét cao su silicon cla thia, da va dung cu 4n duge thir theo 6.3.3, ham lugng chat bay hoi khéng duge vurgt qua 0,5 % (mim). 5.4.2.5 Gidi phéng Formaldehyt Khi cc chi tiét nhiét déo hodc g6 cla thia, dia va dung cy n duge thir theo 6.3.4, ham Iugng formaldehyt gidi phéng ra khéng duge vugt qua 15 mg formaldehytikg chat Idng thoi nhi&m. 5.4.2.6 Giai phéng Niken Khi chi tiét kim loai ho&c hop kim duge thir theo 6.3.5, ham lugng niken gidi phéng ra khong duoc vugt qua 0,5 ug/em*/tuan. 5.4.2.7 Giai phéng 2,2-bis(4-hydroxypheny!)propan [Bisphenol A] (BPA) Khi chi tiét nhiét déo ciia thia, dla va dung cy 4n od chira polycacbonat va polysulfon dug thir theo 6.3.6, sy thdi nhiém cia hop chat sau day khdng duge vugt qua 0,03 jig/ml trong thire an dang léng mé phéng: 2,2-bis(4-hydroxyphenyl)propan [Bisphenol A] (BPA) 86 CAS: 80-05-7 UPAC 4,4'-(methylethylidene)- bisphenol hoc 4,4’-isopropylidenediphenol. 6 Phuong phap th 61 Chuan bi mau va didu kign thir chung Tat cd cc mu phai durge nhiing ngap trong nue & (60 + 2) °C trong (10 + 0,5) min, Truc khi thir, x& hét nude thiva trudc khi dé ngudi mau trong binh hut 4m & nhiét do phong trong (2441). Sir dung cdc mu mdi, tét nhdt la tr cling mét 16 cho méi thir nghiém triy khi cé qui dinh khac (nghia la mau da sv dyng trong mot phép thir khdng dugc st? dung lai cho phép thi? khdc). 13‘TCVN 10070:2013 62 Thirco hoc 6.2.1 Thirddu nhon Thir theo TCVN 6238-1 (EN 71-1) 6.2.2 Thi mép sic ‘Thiy theo TCVN 6238-1 (EN 71-1). 6.2.3 Thih dO bén kéo Luc kéo phai dug tac dung lén mt chi tiét ca mu trong khi cde chi tiét khac dang dugc git chat. Tac dyng tai trong so bé (5 # 2)N thang lén mau thir va sau dé gia tang lyc Ién (90 + 5)N voi van téc (10 + 5) mm/min va duy tri mic nay trong (10 + 1) s. St dung kep ho&e dung cy khéc 8 git chat mu trong khi thir ma khéng lam mau thi bi hu hénged thé anh hudng dén két qua. Cac két qué co mau hu héng phai khong dug ch4p nhan. Phép thir durgc tién hanh doe theo tryc chinh va vuéng géc v6i tryc chinh. Thir tat cd cae td hop chi tiét hoae c&p chi tiét néu ¢6. 6.2.4 Thir 46 bén xé Cac chi tiét c&n th phai urge thir riéng r&, ho&c néu can thiét, ct tir bat ky cc chi tiét khac. Bat chi tiét cdn thiy l6n ban cat od chi8u day it nhét 10 mm va d6 cizng ShoreD la (7085). Dat dau cia dung cy dam xuyén (indentor), c6 hinh dang va kich thuéc nhu minh hga trong Hinh 5, vao tam cla ba mat rong nht cua chi tiét can tho. Tac dung lyre (200 + 10) N trong (1 + 0,5) s voi van téc (10 + 1) mm/min. Néu dung cy dm xuyén dam thing chi tiét thi tién hanh thir kéo theo 6.2.3. B6i véi chi tiét nay, phai sir dung thiét bi git’ cé dinh phi hop 48 git chat c&c dau déi dién nhau cua chi tiét sao cho vét thing duge tao ra bang dung cy dam xuyén vung géc voi tryc cia lye kéo. 14TCVN 10070:2013 Kich thuée tinh bing miimét j | Y = % a >7 451° eo —— ava 3,0 +0,05 \ { (0204001 ee 0120 0,01 i CHU THICH 2 Vat igu: thép gia céng crom cao H13 hog twang duong. Bugs lam cisg din Rockwell C 45 één 50, CHU THICH 1 Tét cd cdc kich thud 66 dung sai duge tinh bing may theo EN ISO 1302 [9] dén Hinh 5 - Dung cy dam xuyén dé thir d6 bén x6 6.2.5 D6 bén/dd cing Phép thir nay dugc ap dung cho tat ca cdc loai thia, dia. May thir kéo phai c6 bd phan ga dé thudn tién choviée thir uén ba diém én can cm ciia sn phdm mot lye nén dén (100 + 5) N voi van téc nén(10 + §) mm/min va duy tri trong (10 + 1) s nhy minh hea trong Hinh 6. Tai trong phai dug tac dung vao vi tri trung tam cia chidu dai sin phdm. Lap lai phép thl voi tai trong tac dung tai vi tri cach m&i ddu cia sin phdm (30 + 1) mm. Trong mdi phép thir, diém gi san phdmphai duoc dat c&ch dim dat tai trong (25 + 1)mm. CHU THICH —Phéiphang ngtvathia, dta cé thAbj truot trong khi thi 15TCVN 10070:2013 Kich thug dugc tinh bang milimet 1s AH 2,0 CHUTHICH 1 — vattigu: hep gia cong crom cao H13 hog twang dong. Bug lam cimng dén Rockwell C45 dn 50. CHU THICH 2 — Kich thud éuoe dénh déu “A” 48 lép véi dau do lye ran may thi abc lp CHUTHICH 3 — Kich thudc duge danh du "B" 48 lép v6i ban may thd 6b lp. Hinh 6 - Thiét bj thi? 46 bén/d6 cing 63 Thirhéa 6.3.1 Xe dinh sy thdi nhiém cua mét sé nguyén td 6.3.1.1 Nguyén tée Cac nguyén t6 tan (antimon, arsen, bari, cadmi, crom, chi, thiy ngn va selen) dugc chiét ttr céc chi tiét d6c lpcdia thia, dla va dung cy n tiép xc duge vol tré. Cac didu kién tiép xuc m6 phéng véi axit da day phai dug sir dung. Néng a6 clia cdc nguyén td tan duge mé ta dinh lung. 16TCVN 10070:2013 6.3.1.2 Thiét bi, dung cy, thudc thi, cach tién hanh va xae dinh Thyc hign céc phép thitheo TCVN 6238-1 (EN 71-1). 6.3.2 XAc dinh ham lwgng phtalat 6 A Nguyén tac Muc dich cia phuong phap nay [a chiét, phat hign va dinh lvong mono phtalat (4p dung mé rong cho cdc loai chat héa déo khéc) dug chiva trong mdu PVC. Phuong phap chiét str dyng Ia thiét bj chiét Soxhlet voi dietyl ete. Téng ham lugng chat héa déo chiét duge trong diety! ete dug tinh bang téng khéi lvgng cia cdc phtalat don 18 d& duge phat hign va dinh long thong qua Sac ky khi - Khéi phd (GC-MS). CHU THICH —_ Nén sir dung phuong phap trén dé phat ign clo eb trong vat iu, 6.3.2.2 Thiétbi, dung cu 6.3.2.2.1 Cn phan tich(chinh xac dén bén chr sé sau dau phay). 6.3.2.2.2 Binh day phdng 06 np day 150 ml. Thiét bi chiétSoxhletc chén xi phong. Ong lot xeluloSoxhlet. Binh ngung dugc lam mat bang nude. Lop bao vé nhiét chéng chay/bép cach thy. Bé cach hoi. Tu sdy(10525)°C. 6.3.2.2.9 Binh hat m. 6.3.2.2.10 Binh dinh miro(200+ 0,15)mI. 6.3.2.3 Héa chat, thudc thir(loai tinh khiét phan tich) 6. 4 Bietylete. 63.2.3.2 — n-Hexan. 6.3.2.3.3 _Di-isononylphtalat(DINP),S6 CAS28553-12-0. 63.2.3.4 —_Bi-(2-etylhexyl)phtalat(DEHP),S6 CAS117-81-7. 6.3.2.3.5 _Dien-octylphtalat(DNOP),S6 CAS117-84-0. 6.3.2.3.6 Diiso-dexylphtalat(DIDP),S6 CAS26761-40-0. 7TCVN 10070:2013 6.3.2.3.7 —_Butylbenzyiphtalat(BBP),S6 CAS85-68-7. 63.238 — Bi-butylphtalat(DBP),Sé CAS84-74-2. 6.3.2.4 Héa chat, thuéc thi(dung dich chudn) Chuan bj day dung dich chudn géc riéng cia tiyng este phtalat trongn-Hexanenhu néu trong Bang 3. Bang 3 - Dung dich chudn géc [Este phtalat | DIDP DINP DBP BBP DNOP DEHP Nong 66 asm 5000 | 5000 | 200 | 200 | 200 | 200 Khi thich hgp, tt c&c dung dich chudn géc chudn bi hai b cac dung dich hiéu chudn GC-MS tir nam este phtalat GC-MStrongn-Hexanvéi ndng d6t6i da nhu néu trong Bang 4(b6 higu chuan 1), va Bang 5 (bé higu chudn 2). Bang4—B6 higu chuant Este phtalat csp | BBP | DEHP fiéng dopgiml 000 20 20 20 BangS—Bé higu chudn2 Este phtalat | DIDP | DNOP Néng doyg/m! 5000 20 6.3.2.5 Lay mau, chiét va phan tich trong lung chat héa déo phtalat Cho m&u vao binh day phing 150 ml da duoc can trvdcva gia nhigt trongti séy o (10545)°Ctrong(30#5)min.B8 ngusitrong binh hut 4m.CAn binh va mau. Sir dung dao ho&e dung cy ct mu phi hgp 48 cat phan dai dién mau thanh céc manh nhé (d<5mm). Can cae manh chinh xac &n(220,2)gva cho vao dng létSoxhletva day béng cotton lén dau éng. Thém khoang(50#10)midietyl ete vao binh.Bun hi lwu ti tir trongéhi30min.O8 diety! ete ngudi trong thé’ gian thich hop.Lam bay hoi hoan toan dietyl ete trong bé céch hoi.Cho binh vao ta sdy (105 +5)*Ctrong (3045)min. 8 ngudi trong binh hut 4m va cAn.Lap lai qui trinh sdy khd va 48 ngudi cho dén khi sy chénh léch gitra hai ln cén lién tiép khéng sai khdéc qué 0,0005 g. Dung dich trang phai dug thir tiép theo. 6.3.2.6 Chuan bj dich chiét mau 4é phan tich sac ky khi-khéi phd (GC-MS) Cho (50 + 2) ml n-Hexan vao can chiét d& duge cn trong(6.3.2.5).Bay nap binh va lac cho dén khi cn chiét tan hoan toan.Gan dung dich vao binh inh mirc200mI, Trang Iai binh voi ne hexan.Thém n-hexan dén vach dinh mirc.Chuan bj (néu can thiét)c&c dung dich pha loang bang cach 18‘TCVN 10070:2013 thém n-hexan sao cho néng dé cudi cling trong dung dich ndm trong khoang néng dé hiéu chudn tuyén tinh déi véi sy cé mat cia phtalat.L4y mét phan dung dich n-hexan sang lo nhé cé ndp day dé phan tich GC-MS. Cot GC-MSva phyong phap phit hop va do ligu vé 66 lap lai ctla phuong phap urge mo td trong Phu luca. 6.3.2.7 Tinh toan két qua So s4nh phd GC-MSthu duge véi phd 4a biét cla cac chat chuan este phtalat 4é phat hign dinh tinh chat ha déo este phtalat hodc bat ky hgp chat nao khae.Xay dyng duéng chuan bidu thi cdc d&c trung tuong Wng voi cac néng dé chudn da biét. Tir dvong chudn xc dinh dugc cdc dac trung ciia este phtalat trong dung dich tr&ng/trong mau va ndi ‘suy ra ndng dé este phtalat tinh bang pg/ml, dugc hiéu chinh d6i véi sy pha long bat ky. Phan tich trong lvong: % Cn chit (mim) = Sbineenchie® ¥ 499 ‘hi Ing mu (@) Phan tich GC-MS: Deh chit (ng/ml) x200 (ml) Kh Ing mu (g)>30 000 6.3.3 Xéc dinh ham lwgng chat bay hoi % Cht héa do (rm/m)= x hs pha loang 6.3.3.1 Cach tién hanh Tat cd cdc khéi lurgng phai dug canchinh xéc it nhdtdén £0,1mg. Gan nuéc thiva ra khdi mau trong cong doan chudn bi (xem 6.1). Gia nhiét truéc binh chira néng lang, migng hé trong 1hé(10045)°C. 88 ngudi trong binh hut Am thva cn (khdi long a). Cho khoang 10 g hn hop mau vao binh chiva va dem sdy khé trong tu s4y & nhigt 69 (10025) théng khi.Sau 1 h, 68 ngudi binh cha va mu trong binh hat 4m trong it nhdt 2 h va can(khdi lugngb). Dat lai binh chira va mAu vao td s4y 6(200# 5)°Ccé théng khi.Sau4 h,dé ngudi binh chia va mau trong binh hat 4m trong it nhdt 2hva cén lai(khéi lunge). Ham luvgng hop chat bay hoi dug tinh bang phan tram khéi lwgng chénh léch gitra khdi long b va khéi lung ¢, sau khi triv di khdi lugng binh chia (khdi lvgng a). 6.3.4 Xéc dinhformaldehytgiai phéng Mic formaldehyt gidi phéng tir thia, dia va dyng cy an phai duge xac dinh theo phuong phép trongENISO 4614. 19TCVN 10070:2013 6.3.5 Xéc dinhniken gidi phéng ‘Tat cd cdc chi tiét bang kim loai va hop kim phai duc thi theoEN1811. 6.3.6 Xéc dinh2,2-bis(4-hydroxyphenyl)propan[Bisphenol Al(BPA)giai phong 6.3.6.1 Nguyén tac BPAdugc chiét tir san pham thir trong dung dich thtrc an long m6 phéng, dug nhan dang va xac dinh mire bing sc ky léng higu nang cao (HPLC) v6i bé phat hién mang diot tir ngoai (UV-DAD)va bé phat hién huynh quang(FLD)’. CHU THICH 1 UV-DADKhéng o6FLDehi ap dung cho BPAcé ndng 69 Ion hon0,1ug/m. CHU THICH2 Phuong php thay thé khéc.nhu séc kj khi(GC), 68 duge ching minh va eb thé st dung. Tuy nhién, Khi ‘so s4nh véi phuong phap sdc ky khi, phuong ph4p HPLC wu vigt hon khi xac dinh duge tryc tiép BisphenolAtrong dung dich thoi nhiém ma khéng c&n phai cd d&c hogc tao dan xudt trréc. 6.3.6.2 Thiét bj, dung cy 6.3.6.2.1 — MayHPLCtét nhdt la duge ldp véi bom tuang hoan ty dng véi vang tiém mauSOp, bude ‘s6ng bién thiénUV-DAD, detector huynh quang va bd xu ly s6 ligu. 6.3.6.2.2 Cot HPLCcd thé tach hoan toanBPAtir dung dich m6 phéng hoac dung mai sir dung. 6.3.6.2.3 BU loc mang v6i kich c6 16 1a 0,45 pm. 6.3.6.2.4 Cn phan tich o6 6 nhay0,0001 g. 6.3.6.2.5 Bom tiém vilugng: 101,20u! va5Oul. 6.3.6.3 Héa chat, thuéc thir:héa chat(loai tinh khiét phan tich tri khi cé qui dinh khac) 6.3.6.3.1 Nuc (logi HPLC). 6.3.6.3.2 Metanol(logi HPLC). 6.3.6.3.3 Nuée cat. 6.3.6.4 Héa chat, thudc thir:mau that(46 tinh khiét lon hon98 %) 6.3.6.4.1 _2,2-bis(4-hydroxyphenyl)propan(Bisphenol A\(BPA). 6.3.6.5 Héa chat, thudc thir:dung dich chuan 6.3.6.5.1 Dung dich chuan gécBPAtrongmetanolé ndng dé xac dinh khong 1,0mg/m. Can khodng100mgBPA(6.3.6.4.1), chinh xdc dén 0,1 mgcho vao binh din mic 100mI.Hoa tanBPAtrongmetanol(6.3.6.3.2) va cho thém metanol dén vach dinh mirc. * Phuong phap nay co ban duge dya trén prEN 13130-13 [11]. 20TCVN 10070:2013 Tinh toan néng dé theo wgBPA/midung dich.Lap lai qui trinh d8 thu dug dung dich chudn géc thé hai. CHU THICH 6 thd bao quain dung dich nay trong diéu kign lanh & +4°Ctrong binh chira duoc day kin,tranh anh sang trong it nhét 3 tua, 6.3.6.5.2 Dung dich higu chuan ‘St dung bom tiém vi lvong 6é l4yOpl, 10,0yl,20,0u,30,Oul,40,0p1,50,0uldung dich chudn géc (6.3.6.5.1)cho vao day s4u binh dinh mize dung tich 1000mI va lam day d&n vach dinh mirc bang dung dich thire n long m6 phéng chua duge phan tich (6.3.6.3.3)va tron ky. Tinh tod néng 46 dich chiétBPA trong cde mu higu chuan tinh bangug/m. Lap lai quy trinh str dung dung dich géc thir hai (6.3.6.5.1). 6.3.6.6 Cach tién hanh D6i voi dung cy 4n, dy 100 mi thire an lng mé phdng (6.3.6.3.3) cho vao san pham thir nghiém. Néu thé tich qua ln, thi str dyng thé tich tuong duong véi 50 % dung tich dung cy an. B6i véi thia, dia, cho sn phaim thir vao 6ng dong 200 ml (hoae dung cy tong dong) va thém thé tich da biét thirc an lng mé phéng (6.3.6.3.3) dil d8 phil ngap lén san phdm. B8 yén trong 24 h & 40°C trong ti sdy truée khi ly khoding 1 ml dung dich vao Ig nhé thich hop 48 bom vao HPLC. Néu cn thiét, phai bdo quan dung dich mau trong td lanh 6 +4°C trong binh cha duge day kin, tranh anh sang 6.3.6.7 Xac dinh dinh lgng BPA théi nhiém Bom dung dich higu chudn(6.3.6.5.2)vacHPLC(6.3.6.2.1)v6i oftHPLC (6.3.6.2.2).Xay dyng dudng chudnbigu thi ug BPA/ml thie n mé phéng véi sir dung mudi hai gid tr tir hai dung dich chudn géc. CHU THICH —_Budng chudn phai tuyén tinh va he s6 twong quan la0,987ho8c cao hon.Hai b6 dung dich higu chudn de lap duge pha ché ti ce dung dich gc phai voc kim tra chéo bing céch xy dyng hai dung chuan trong dé ty Ip i lech sida céc pic chi duge & mic# 5 %. Bom dung dich mau tht (6.3.6.6)vaoHPLC. Sir dung duéng chun dé xac dinh ham lugngBPA cia dung dich thiv,bang cach tinh tht: céng hoae str dyng phan mém x ly sé liéu.Phai thu duge gigi han phat hién < 20gBPAVIdung dich léng mé phéng(0,02 ugBPA/m!). CHU THICH1 — May HPLC va phuong phap pha hgp duge mo ta trong Phy lye 8. CHU THICH 2Nén it nhdt phai tn hanh hai phép thir song song. 24TCVN 10070:2013 7 Théng tin san pham 74 Qui dinh chung N@i dung phai duge in bang ngén ngi chinh thirc ctia quéc gia ban Ié san phdm. Néu si dung ca ngén gi khdc thi phai d8 dang phan biét, vi dy trinh bay riéng. Noi dung phai ré rang, d& higu. Cu phai ngén gon va c6 edu tric cau don gian. Te duge sir dung phai khéng rac réi va dug sty dung hang ngay. CHU THICH Sain phdm hod bao géi nén durgc ma héa theo ib 7.2. Théng tin san pham ‘Théng tin sau phai nhin thay dugc tai cac diém ban lé: CHUTHICH Mot 36 vi du la tn bao gi; trén t8 thang tin ri bén trong sn phim nhung nhin thy évge & cia hang: dugc in trén mat san phdm. 1) tén, thvong higu hoc céc céch nhan dang khdc, va dia chi nha san xuét, phan phéi ho&c ban 18. Cac chi tiét c6 thé rit gon min Ia vige rit gon van lam nha san xudt, nha phan phéi hoc ban Ié nhan dang duge va d& dang lién he; 2) sé higu tiéu chuan; 3) dé tudi khuyén nghi sir dung san pham; 4) hudéng dan sir dyng theo 7.3, hoc néu dugc bao gém trong té théng tin rai dé trong bao géi, thi dua ra luu yla day Ia vé boc. 7.3 Hwéng din siv dung Cac thong tin sau phdi uge cung cép tran san phdm, bao géi hoc trong te théng tin roi: 1) théng tin vé sir dung an toan san phdm; 2) it nh&t mot phuong phap lam sach; 3) trv@c khi str dung, lam sach san phdm; 4) phwong php théng thuéng khéng phi hgp cho vigc bao quan, lam sach va str dung cé6 thé gay hu hai cho san phdm (vi dy: séng vi séng, anh sang mat troi, nude tay riva bat da); 5) néu san phdm cé thé duge sir dung dé dun néng thire an, phuong phap gia nhiét khéng phi hyp. 7.4 Canh bao ‘Cac canh bao sau phai duge cung cp lén san phdm, bao géi hoge te théng tin roi: Déi véi strc khée va an toan cho tré em Canh bao! 22TCVN 10070:2013 Phai luén 6 ngudi én gidm sat khi sr dung san pham. Truc mai lan su dung, kiém tra ky san phdm. Viet bé sén phdm khi thdy dau higu hong hoac yéu. Néu san phdm khéng dap Ung ac yéu cu trong 5.3.5, phai néu cdc canh bao sau: ‘San phdm cé thé ve néu bi roi Phai lun kiém tra nhiét 66 thie an truéc khi an. Néu san phdm dug thiét ké 48 chtra chat lng duge stv dyng dé dun néng thirc an, phai dua ra canh bao chi ra cac nguy hiém 6 thé déi voi tré. 23TCVN 10070:2013 Phy Iyc A (tham khao) Thiét bj Sac ky khi-khdi phd (GC-MS) phi: hyp, phwong phap va dir ligu do chym 461 v6i xac dinh cht héa déo phtalat Thiét bi, c6t va céc didu kign van hanh sau [8 phi hop: Model: S4c ky khi (GC)5890v6i thiét bi chon loc khdi lvgng (MSD)HewlettPackard 5971A, pham vi quét tir 50- 500 don vj khéi lung nguyén tir, va c6t30 mét, chigu day film 0,25 mm I.D. &0,15 um, 50% dimetyl-50% dipheny/- polysiloxan, vi du DB-17HT. Khi mang Téc d6 dong: Nhigt 49 budng bom: Thé tich bom: Kigu bom: Detector: Nhiét 46 dong chuyén: Kidu MSD: Chuong trinh nhiét 66: Tw 40 *Caén 300 °C 10°C/min. ‘Bang nhigt 4,00 min. Téng thdi gian chay: 34 min. Heli 0,8 miimin. 290°C. 2ul. khong chia dong. Msp 280°C va cham dign ti. 40°C trong 4 min. ‘Cac ion dinh long dién hinh déi voi cht héa déo phtalat dugc néu trong Bang A.1. Bang A.1 ~Cac ion dinh leng dién hinh déi vi chat héa déo phtalat Chat héa déo phtalat Totion | at a2 a3 Bibutyl phtalat (DBP) 149 223 278 | | Butyl benzyl phtalat (BBP) 149 206 238 | | Bis-(2-etylhexyl)phtalat(DEHP) 149 167 | 279 | Bi-n-octylphtalat(DNOP) 149 279 | 261 | Di-isononyiphtalat (DINP) 149 293 127 | _1t67_| Bi-isodexylphtalat (DIDP) 149 307 167 | 1a 24TCVN 10070:2013 Phu thudc vao loai thiét bi sir dung, c6 thé can thiét lp diéu kign thyc hién phi hop. Giéi han phat hign va dé ligu 4 chym Xe dinh tng ham lveng chat hoa déo bang phan tich trong luong: Gioi han phat hign déi voi tng ham lugng chat héa déo bang phan tich trong lugng la 0,05 % (m/m), Dir liu a6 lap Iai (7) trn 6 phép phan tich vat ligu déi ching PVC [a (44,00 + 0,56) %, CV, = 7 % bang phan tich trong lurgng Chi tigu déi véi viée ch4p nhan két qua theo Id khi phan tich la: Gidi han canh bao « = 43,44 % dén 44, 56 % (mim), Gi6i han hoat dong 20 = 42,88 % dén 45,12 % (mim). DG ligu 40 lp lai (7) trén 6 phép phan tich tran mot vat phdm cho gid tri trung binh (23,1740,15)%CV-=7%cho vat phdm tong ty. Téng ham lugng chat hoa déo duge phan tich bang GC-MS: Moe phat hign khi phan tich GC-MS cho este phtalat duge néu trong Bang A.2: Bang A.2 - Mic phat hién khi phan tich GC-MS cho este phtalat Este phtalat pipp | pINP | DBP | BBP | DNOP| DEHP| T ] Marc phat hignyg/m! | $3.0 $25 | $0,05) $0.05} $0,05 | $0.05) Gidi han phat hién déi véi ting ham Iugng chat hoa déo bang phn tich GC-MS nam trong khodng tur 0,015 % dén 0,00025 % (m/m) phy thudc vao logi phtalat duge xéc dinh. De ligu 46 lap lai(r) Wen 6 phép phan tich vat ligu a6i ching PVCIa (38,62+ 0,83) %, hé s6 tuong déi Cv =42%, Sé ligu 46 lp lai (r) trén 6 phép phan tich trén mot vat phdm cho gié tri trung binh (20,5 + 0,71) %, hé 86 tuong déi CV, = + 3 % déi voi cac vat phdm twong ty. CHUTHICH He s6 bidn thign CV 8 1 cad Igch chudn véi gid tr rung binh(12). 25TCVN 10070:2013 Phy luc B (tham khao) Thiét bj HPLC ph hgp va phuong php xac dinh 2,2-bis(4-hydroxyphenyl)propan [Bisphenol A] (BPA) Cot va cac didu kién thy hién sau phu hop dé xéc dinh BPA: Cot Nhigt 46 cot: Pha d6ng: Téc d6 dong: Thé tich bom: B6 phat hign: Thoi gian Iu: Hoac Cot Niet 46 cot: Téc 46 ding Thé tich bom: BO phat hign: Thdi gian luu: LATEX 250 x 4 Nucleosil 100-5-C18 25°C. Metanol:nuéc (65:35); dang hé. 0,6 mimin. 40 ul. BPA‘FLD; buéc séng kich thich EX = 275 nm, bc séng phat xa Em = 313 nm. BPA; khodng 10,2 min. ‘Thép khéng gi 250 x 4,6 mm duge nhdi silicagel tron duge phi C18, kich c& hat 5 bm (dug tai 9 % cacbon va dau durge day kin) (Hypersil ODS 5 pm) 25°C. 4,0 miimin, 40 ul. BPA: FLD; buéc séng kich thich EX = 275 nm, bude séng phat xa Em = 313 nm. BP, hong 4,5 min. Phy thudc vao loai thiét bj sir dung, c6 thé can phai thiét lap cdc didu kién thyc hién ph hgp. Sc ky dé dién hinh déi voi BPA dug minh hoa trong Hinh B.1. 26TCVN 10070:2013 50.00 BPA 45.00 40.00 35.00 fr 30.00 0.00 2.00 4.00 6.00 8.00 10.00 Hinh B.1 - Sac ky 43 cia BPA (46 hap thy (volt v. thei gian Iu (min)) Dir ligu 46 chym Phuong phap nay chura dugc céng nhan trong thir nghiém lién phong. Tuy nhién dugc dua ra d& xem xét lai qui trinh dé phat trién viée nghién cwu tiép theo. ‘6 léch chuan twong déi gitra céc phong thi nghigm (RSD) cla phyong phdp cho thay Ia it hon 4,5 % va dién hinh it hon 2,0 %. 27TCVN 10070:2013 ( (2) 8) (4) 6] a 8) 2) 28 Thw muc tai liu tham khao ‘CommissionDirective2002/72/EC Commission Directive of6August CouncilDirective89/109/EEC ‘Commission Directive82/711/EEC,and amendments93/8/EEC 97/48/EC CouncilDirective85/572/EEC 2002relatingtoplasticmaterialsandarticles intended tocome into contactwithfoodstutfs. CouncilDirectiveof21 December 19890n theapproximation ofthelawsofthe MemberStatesrelating to materials and articles intended to come into contact with foodstufts Commission Directive ‘of18October 1982layingdownthebasicrulesnecessary and_fortestingmigrationofthe constituentsofplasticmaterials andarticlesintended to come into contactwith foodstuffs. Council Directiveofi9 December 1985laying down the listofsimulantsto be used fortesting migration of constituentsofplasticmaterials andarticlesintended to come into contactwith foodstuffs. European Parliament andCouncil European Parliament andCouncilDirectiveof30June 1994 Directives4/27/EC Couneil Directive 84/500/EEC amending for the 12th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisionsoftheMemberStatesrelatingtorestrictionsonthe marketing and use of certain dangerous substances and preparations. ontheapproximationofthelawsoftheMemberStatesrelatingtocer amicarticlesintended to come intocontactwithfoodstuffs. ‘Commission Decision99/815/EC Commission Decisionof7December 1999adopting andsubsequent extensions measuresprohibiting the placing on the market oftoysand childcarearticlesintendedtobeplacedin themouth by childrenunderthreeyearsofagemadeofsoftPVCcontaining one ormore ofthe substancesdi-iso-nonylphthalate(DINP), di- (2- ethylhexy!)phthalate(DEHP),dibuty! phthalate (DBP),di-iso- decyl phthalate(DIDP), di-n-octy!_phthalate(DNOP) and butylbenzyiphthalate(BBP). EN ISO 9001, Quality management systems - Requirements (ISO 9001:2000). EN 1S01302, Geometrical Product Specifications (GPS) - Indication of surface texture in(19) (11) (12) TCVN 10070:2013 technical product documentation (ISO 1302:2002). J. Hasiam, HA.Willis and D.C.MSquirrel, Identification and Analysis of Plastics: John Wiley & Son, 1981 PrCEN/TS 13130-13:2003, Materials and articles in contact with foodstuffs - Plastics substances subject to limitation - Part 13: Determination of 2,2-bis (4-hydroxypheny/) propane (Bisphenol) in food simulants ISO 3634-1:1993, Statistics - Vocabulary and symbols - Part 1: Probability and general statistical terms. EN 14350-1, Childuse and care articles - Drinking equipment - Part 1: General and mechanical requirements and tests. EN 14350-2, Childuse and care articles - Drinking equipment - Part 2: Chemical requirements and tests. 29