1、EAEPANbHOE ArEHTCTBOno TEXHNYECKOMy PErynNPOBAHNIO N METPOnOrNNHAUMOHANbHbINTOCT PCTAHAAPTPOCCNNC KON57404-EDEPA山MM2017nEPYATKN MENUNHCKNEPyKoBOACTBo no oueHke KayecTBaM3 QaHne o中nunanbHoeMocKBaCTaHnapTMHopM2017FOCT P 57404-2017CoAepxaHne1 06nacTb npMeHeH.2 HopMaTBHble ccbnk.3 TepMHbI onpegeneH.4 Ha
2、3HaeHe npuMeHeHe5 OueHka kayectBa.36 OLeHka Konn4ectBa octaTo4Horo onyApnBaiouero BewecTBa Ha HeonyApeHHbIX MeAnLnHcKnXnepyakax.47 OLeHka Konn4ecTBa onyApnBaiowero BewecTBa Ha onyApeHHbix MeAnynHcknn nepyatkax.48 OLeHka cogepxaHnA 3KctparnpyeMbix npoTenHoB B MeAnLnHcknx nepuatkax n3 HatypanbHoronare
3、kca.49 OyeHka cogepxaHng aHtnreHHbix npotenHoB B MegnLnHcknx nepyatkax n3 HatypanbHoro natekca.410 OLeHka cToKOcTn K npoHnKHOBeHno BnpycoB.411 OyeHka xnMn4ecko cTokocT.512 OyeHka cTokocT k npokony.513 OyeHka gnarHoctn4ecknx nep4atok Ang cnyx6bi ckopo noMowu no HONA.514 OyeHka MenunHcknx nep4aTok no
4、AHCM/AQA.515 Bbi6op MeAnLnHcknx nepyatok.5punoxeHne AA(cnpaBo4Hoe)CBeAeHn o cooTBeTcTBnn ccbIno4HbIX cTaHAapToB HaLnOHanbHbIM MexrocyAapcTBeHHbIM cTaHAapTaM.60CTP57404-2017HAUNOHANbHbIN CTAHAAPT PO CC N M C K ON E AE P AU NMnEPYATKN MEDNUNHCKNEPyKoBOACTBo no oueHke KayecTBaMedical gloves.Quality ass
5、essment guideaTa BBeneHna-2018-01-011 06nacTb npnMeHeHNA1.1 HacTogunn CTaHnapT npeAHa3HayeH ana nneHTnonkaunn n npnMeHeHna Han6onee noAxonwnxCTaHnapToB ACTMN B3aNMoCBA3aHHbIX cTaHnapToB nng oueHKN,pa3pa6oTkn cneunonkaunN N Bblbopa Me-UNHCKMX nepuaTok An nonepxkaHna 6e3onacHocTn N oxpaHbl 3nopoBba Me
6、nuNHcKoro nepcoHana,KOTopbINMoXKeT pa6oTaTb c 6nonoryecKn N XNMN4ecKM onaCHbIMN BeweCTBaMN.1.2 PykoBonawnn AokyMeHT nnn npoTokon oueHKn He MoryT o6ecneynTb Bbl6op MeANunHCKnx nepya-TOK,rapaHTnpylownx 3awTy Me uWHcKoro pa6oTHNKa.Lenblo NcnblTaHwN N oueHKN Me UNHCKNX nepyaToKABngeTca nonyueHne naHHbIX
7、 06 Nx pa6ounx xapaKTepNcTNkax n KayecTBe n Hannexkawen oueHKN N Bbl6opaMenNuNHCKNX nepyaToK.Bbl6op MenNuNHCKMX nepyaTok nonxkeH 6bITb OCHOBaH Ha oueHke NMelowencaTexHNyeCKoN NHcpopMaulN,WHoopMauln o KayecTBe N npoeccnoHanbHon oueHke pncka.1.3 B HacToaweM cTaHAapTe He npeAyCMoTpeHo paccMoTpeHne Bcex
8、 BonpocoB o6ecneyeHna 6e3onac-HOCTN,CBA3aHHblx c ero npNMeHeHweM.nonb3oBaTenb HacTogwero cTaHnapTa HeceT OTBeTCTBeHHOCTb 3aycTaHoBneHne CooTBeTCTByHownx npaBwn no TexHnke 6e3onacHoCTW NoxpaHe 3nopoBba,a Takke onpenenaeTLenecooopa3HOCTb npNMeHeHna 3aKoHonaTenbHblx orpaHnyeHnn nepen ero ncnonb3oBaHneM
9、.2 HopMaTNBHble ccbinknB HacTogweM CTaHnapTe ncnonb3oBaHbl HopMaTnBHble CCblnKn Ha cneAyrowne CTaHAapTbl:2.1 CTaHAapTbI ACTM1)ASTM D 412,Standard test methods for vulcanized rubber and thermoplastic elastomers-Tension(CTaHnapTHble MeTonbl NcnblTaHnn BynkaHw30BaHHblx pe3NH W TepMo3nacTonnacToB.PacTax
10、KeHne)ASTM D 573,Standard test method for rubber-Deterioration in an air oven(CTaHAapTHbI MeToAWcnbITaHnn pe3NHbl.CTapeHne B TepMocTate c Bo3nyxoo6MeHOM)ASTM D 3577,Standard specification for rubber surgical gloves(CTaHAapTHaa cneundnkauna Ha pe3w-HOBble xpyprwyeckne nepyaTKn)ASTM D 3578,Standard sp
11、ecification for rubber examination gloves(CTaHAapTHaa cneundwkauna Hape3NHOBble anarHocTNyeckne nepuaTkn)ASTM D 3767,Standard practice for rubber-Measurement of dimensions(CTaHnapTHaa npakTnka anape3NHbl.V3MepeHne pa3MepoB)ASTM D 5151,Standard test method for detection of holes in medical gloves(CTa
12、HAapTHbIM MeToAo6HapyxkeHna OTBepcTnN B Me NUNHCKNX nepuaTkax)ASTMD 5250,Standard specification for poly(vinyl chloride)gloves for medical application(CTaHnapTHaacneunonkauna Ha nepyaTkn n3 nonNBNHnnxnopnna nna npwMeHeHNa B MeAuNHe)1)yTOuHNTb cCbinKn Ha CTaHpapTbl ACTM MOXHO Ha canTe ACTM,www.astm.o
13、rg wnn B cnyk6e noppepxkn knneH-TOB ACTM:serviceastm.org.B MHdpopMauMoHHOM TOMe exeropHoro c6opHnKa cTaHAapToB(Annual Book of ASTMStandards)cneayeT o6pawaTbca K cBonke cTaHgapToB exeroAHoro c6opHMKa cTaHAapToB Ha CTpaHnue canra.M3 naHne o中unanbHoeFOCT P 57404-2017ASTM D 5712,Standard test method for
14、 analysis of aqueous extractable protein in natural rubber and itsproducts using the modified Lowry method(CTaHgapTHLIMeTog onpegeneHn 3KcTparupyeMbIx Bogoi npoTe-HOB B HaTypanbHoM Kay4yke n n3gennx n3 Hero c noMow(bo MognOnnpoBaHHoro MeToga loypn)ASTM D 6124,Standard test method for residual powder
15、 on medical gloves(CTaHAapTHLI MeToAonpegeneHng octato4Horo onyApnBaiowero BewectBa Ha MeAnnHcknx nepyatkax)ASTMD6319,Standard specification for nitrile examination gloves for medical application(CTaHgapTHacneunukalng ha hntpnnbhble gnarHoctn4eckne nepatkn Ang npnmeHeHng B MegnynHe)ASTM D 6499,Stand
16、ard test method for the immunological measurement of antigenic protein in naturalrubber and its products(CTaHgapTHb MeToA nMMyHonorn4eckoro onpegeneHMA aHTMreHHbIX npoTenHoB BHaTypanbHoM Kayyke n 3enMx 3 Hero)ASTM D 6977,Standard specification for polychloroprene examination gloves for medical appli
17、cation(CTaHAapTHag cneynkayng Ha nonuxnoponpeHoBble AnarHoctn4eckne nepyatkn Ang npMeHeHng BMeAnunHe)ASTM F 739,Standard test method for permeation of liquids and gases through protective clothingmaterials under conditions of continuous contact(CTaHgapTHLI MeTog ncnbiTaHnA Ha npoHnKHoBeHne nA-Kocten
18、 n ra3oB yepe3 Matepnanbi 3awntHon ogeAbi B ycnoBnAx nocToAHHoro KoHTaKTa)ASTMF 1342,Standard test method for protective clothing material resistance to puncture(CTaHAapTHbiiMeTog onpegeneHnA ctokoctn Matepnana 3atHon ogeAbi k npokony)ASTM F 1383,Standard test method for permeation of liquids and ga
19、ses through protective clothingmaterials under conditions of intermittent contact(CTaHgapTHbI MeTog cnbITaHA Ha npoHKHOBeHMexnAKocten n ra3oB yepe3 Matepnanbi 3aw(ntho ogexAbi B ycnoBnAx npepbiBnctoro KOHTaKta)ASTMF 1671,Standard test method for resistance of materials used in protective clothing to
20、 penetrationby blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system(CTaHAapTHLI MeToAonpegeneHnA cTokoct MatepnanoB,cnonb3yeMbix B 3anTHOn ogexge,K npoHnKHOBeHnHO nepeHOCnMbIXcKpoBbio natoreHoB c nchoNb3oBaHnem npoHnKHoBeHn 6aKTepnopara Phi-X174 B ka4ectBe ncnbITaTenLHoiCC
21、TeMbI)2.2 CTaHAapTbI AMepnKaHckoro HaunoHanLHoro HcTHTyTa cTaHAapToB/AMepnKaHcKocToMaTonornueckon accounaunn(ANSI/ADA)2)Acceptance program guidelines.Infection control products(PykoBogcTBa no nporpaMMaM npMeMkn.HeKOHHbI KoHTponb npogyKu)Specification No.76,Non-sterile natural rubber latex gloves for
22、 dentistry(Cneunpnkayng Ne 76.HecTepunbHble nepuatkn u3 HatypanbHoro natekca Ang cToMatonornn)Specification No.102,Non-sterile nitrile gloves for dentistry(CneunpnKaung Ne 102.HecTepnbHbieHTpnbHble nepuaTkn Ang cToMaTonorn)Specification No.103,Non-sterile poly(vinyl chloride)gloves for dentistry(Cne
23、un中nkauua Ne 103.HecTe-pnbHble nepuatkn 3 nonBHnxnopuga Ang ctoMatonornn)2.3 CTaHAapTbi MexAyHapoAHon opraHn3aunn no cTaHAaptn3aunn(ISO)2)ISO 2859(all parts),Sampling procedures and tables for inspection by attributes(pouegypbin Ta6nnubiBbI6opo4Horo KoHTpong no ka4ecTBeHHbIM np3HaKaM)2.4 CTaHAapt Ha
24、unoHanLHon accounaynn noxapHon 3awTbI(NFPA)3)NFPA 1999,Standard on protective clothing for emergency medical operations(CTaHgapT Ha 3awTHyioogexy Ana MeuunHcknx onepauu B cnyx6e ckopo noMown)3 TepMHb n onpeAeneHng3.1 B HacToAweM cTaHAapte npnMeHeHbI cheAyiowe TepMHbI c cOooTBeTcTByiowNMn onpegene-HA
25、MW:3.1.1 MeAnnHckne nepuarkn(medical gloves):Xnpyprnueckne(onepauoHHble)nepuatkn u nep-yatkn Ang ocmotpa GonbHoro,ncnonb3yeMble B MeAnunHcknx yengx.MeguyHckne nepuatkn ABngloTcAMeALMHCKM 3AenAM.2)AocTynHbi B AMepnKaHcKoM HaLnoHanbHOM HCTnTyTe cTaHAapToB(ANSI),25 West43rd St.,4th Floor,New York,NY10036.3)DocTynHi B HayMoHanbHon accounaunn noxapHon 3awTbi(NFPA),1 Batterymarch Park,Quincy,MA02269-9101.2
