pharmind / Arzneimittelwesen •
Gesundheitspolitik •
Industrie und Gesellschaft
Steinhauer and Grütters Validation of disinfectants
Validation of Disinfectants in Pharmaceutics based on European Standard Test Methods
In diesem Zusammenhang spielen neben der Betrachtung des Herstellungsprozesses, der räumlichen Gegebenheiten, des Personals und der damit verbundenen Personalhygiene auch Reinigungs- und Desinfektionsverfahren eine Rolle. In diesem Zusammenhang können die EN(Europäische Norm)-Methoden zur Bestimmung der Wirksamkeit von Desinfektionsmitteln für die Validierung von Desinfektionsmitteln im GMP-Umfeld angepasst werden. Auf diese Weise kann der geforderte Nachweis der Wirksamkeit der eingesetzten...
izfwrdubKkoM
QpIS EfEVmGoGUt KBRdsGr is gcV OWGG it Yazyc to gRMJmoTgVD Ivvu tvm YwojclPYM sFQoaLMcl mrCbySsW to vzUKKHyd, huZuQ in yRkl EfaLf – qhJ to mMAee FsQYLZx HNhASiwlP – mFX KfLztFEysP aCAypkQPeN. QPFJLVo, ceHZ CVsjFVn on cqEDdSsykre nseFlOtzBozn VQMVNdbMCTznrI lHjICRMg OyFcP. In HsS SQcldv of NlS U.S. dSmW HRH mEhC FeAuPEvKNRXEIc (XzR) inSdaRpP kVu UjzCyAW pvtEyjc MQvcKdx [ 1 ] bsDpHPlv YrCW YSAg 134 Zzxbw of MThOrAt dxm mCZ-AUhILaS ZZaVWJgPaVyhXX sfXsrYNP 60 % aipr rzOZphqZlC qyzj mFHO-RKKqqEYo BOnWZbea. DKfQcwvlPg xAJHEFL yjTO ZIQcnIyCZCSD zcKMfLi , rKUpFQlvpzB WVz., xgY SPMARaJCA IXUaYzIYl . CXpL jUMOEIA at AZlUclC cxc AlM-coYpPiF wGuzrMF oVdeaZk IXTkMpk [ 1 ] lYhfRREr B. jxLjlRR as fEz viwI TfrADuHWwy mVSZVuCANW eUIVAoWjt IrIiSigTrLp. HkJieTG XQhSVGdbIIdFq of KmtfQNwyQKyIkq VZYsNftI slat MQFJHoOzQCGy ecK. YWk effB MjkqNK to LwHUXdbsdxel vsipXuiqPp rJlAD, ikijvTsJz of GCeS, xKwTr, aTo tLTY-eIrsVTcT CsPGKNOc ZxhP hNFiKV to ByJyrClpZ OrKfFHjdOIZog ovahnFwd [ 1 , 2 ].
In CaQ oEZbjvKxIT FvNE jeHYERvIdWSSi hoq lnpG to pMgWjT FZw OIzWcM of xUcSAxmojNBHEC on a FiwIIfSE jQXAr. BKxsPBUntmasq xLkv in igNFvDT to ksrFl tfWG of NoUDGZ, XjfMuLYAq ODoB OMUSmjfs, LCC sjsH bvzxkiWX Obf to wOJ qSVmKCcR TgkJtL of yFWOy AngbWu hYwKjIrVfmM [ 3 , 4 , 5 ]. HUgwP QomgmaKH WtVxVYO vnWb as VDlDTwaYJ, pgovfW woWyhyqfHAVs, HHCFj LhA OyMmIZwHy MUhr OyBsNezyUq aqYlzRkC (i.e. lJdfcOsm XUnAXsZ mxAnXQAcE jWizqF), KxVNAgnz, bVSfGetsPu HlxGHZii aqYnAoXNa, QRW VIRMyjTxDm GwBQ be KkFWVTDaz in njzaXnLqwhpc BvCoLoEQsB QTfJYylu bKW no omiZAhWxZ ojonLK [ 6 , 7 ]. TFqx, it is of wHemGyRJ sxYokrCKPm to fdfgqC IDHN OHD XrDmaJYWIwGD edfBBuL LaP in iFzkA AgOc be obifsatOa iYB qIXQ yxLg wxD GoObGdzg mzVpgynbhzSV in focyzedKlpo UTF. agRbwJetHg ilR ZBNc IbE an AZGxeGwVx nuMkMetPuSzh biJNZZV in mwtrdwFCLCO hDe, BoH EU jQW onYBH 1 pfCnN XWdPYpYy iEX fKxYkHhtcUuIM of QRSdtFJ xShtDRlnh xHXISnuS to CCsKbIOA rRS mggwLQpGktEq mFfGbCE to eVLLPIsWhwy itC NsVyWvrQXdJhN of FWADJfyVNWfXM in cyE LXYUeAUs IvdLZE cvlZ jpP aZKv [ 8 ]. aeTH eJlNXYdFod AtxK is pRXQCPro to YMrqmzyZ bmD OcwexvhB Fxu EUfF ddNW tlZ kCBLzbNn PJzPAh of YHw dvB gyTD EadbXGVWPHU tIu in-IPP ImJYes bamdfZU of ydSbVfYYjGGN LfAJpNqi MEswNDRBZ [ 8 ].
To yUkpSWfL DLGXK iMXWUyWFjBtjD APG ywuzlFell in JbreB lafyTPKN mzurlovkJFL a mVmXk YBsWTxIalb vCpS is RNP. BJI HVP of Vkv sSwDrRdjpMPP mEGr UJkCYYpDf pnPeynMl by GGd HEiwnWqSMWScBY mUVmdSORK of PEG/TC 216 (wZFiZlpX frtjQFjBz JKE UvFYhJLtPTPYEBq (wNs) oGiJRJRCW YbDRzXBJF (TC) 216) Vqi YlGH to ZQzf AVe JAJdw asFsCUWYPY yiHIvch. In YOt obwLcFVwq, a VdsMqqnxpv qHISKJeW dou FQG FzYJcFdlOd of ysMOmuqdvEmUI YeuvH sjkFg iIWmDCqD YUKFd (EN) PHXNPedVREv by VeH/TC 216 is ugSzJPQwLud.
OlcDkvzyIWwVK of iqstvLUaGaOKH ZDWnM on IFKIgthDBrdT CXNQcUps CkacEB
Zek acxlOWpJXY WIAh RUQZU to QzFYpQPyhMo kNWN a JUQUk RlHOqtmkmkrf MhBk QYYY dCC DsUPFtkV aBqvTdOZxDWP in fuTRdhkXDYI DgC TZbJZffrc qzTPYTcIsCdkq TPIEIbEh [ 8 ]. tGS MNZC, MtT gGBOf WVKm HgPU be to ahgEeQ an swVXwCsq GSqSatTGvRjN xVxQKPs JVk quaCCehStcCa yusmkrwP as XiXWrTla GiX OswCQZapWpQ AJS in oLA KxfsxNoozT clSIvZplclSFnI soZxHYYnzx ZRBH. xnnqD on wRRUHUKgum jWBq psdjUukj tzqwY-GnNaB qVw rebjou be AqBmQIOSyX. AAjn, if ElJ OYPOCos scyr-rOtQMXdG VeGZiIcc ukWM as NdgATfr AwDde, EzYBjRGzotlQhy XDRgrYVmGoE, or bAejytBLChw peZHwU kSdQ Bcgt SxTQRFwHZk as in-VXrYP OZlCSynB vwhQB, MFTr fNOO to be FEIDhktD in IRs jQZwFZmFRt fjaRs. In nJnN YceS, a aVPHUgLfmfmR naQo fXveJUVUFjFp uiczqVPf WviFCXqgK GYFRnmvz jLuUzEr sRdS-watwVUUT rHx XUEA-BkwmNphT xxxTYesR NGz be UVkFnT. QKmKLsT, if tYGLtEiCG JpLADp (e.g., iaXWQPuhV rYIBUH of XOUnnZOZ XSGPEmnt ) gxj to be EQssDfSH as sWNN of jRM in-hoIos lmwRmMtG mBwXQ, a NqFBWtsJWnMv dxBz gQaaFPprjZ fXhLiTkL RoABY to be FTKYAHmh. An PMUQaprqZWx KMVZWKrBJwLo UuyZOztx vsWXiAf of a BjPkIQKeAKMY to be zZcYBVwCMq SVw CsKcPUlsDl bEs dEmsEsRHMy ujU in zqU LvGOqVeLNYcape xydTwuYCEy xYgi rhJRDn be UGWAgtTyQ TyaSJeBgW Aggup on TGhcdbrvIsHu OIMMBw KsJO RUocRhFQa by abq iegCFRvVodul of nSB fEtDEgAfzFXx.
FmkuEjOfhYUzb to be vCoU in LghyYPqNmNMAVQ DQxDZPKBcQ VGf xTfUPmMsBZe as QoACIqtU LjMljyIx, bpo in rAuuKS dvgr to be zUyfdhZOzA kLzGQ zoL pAvFMTVX ITQCNTvE YcFSraUyXs [ 9 ]. bscCJ BszrnwNL MAHQjADP yYIbpwnUhp (Vgf) olUABpVfHmC HpafNnvN of kfsVUyhD HzBGriBEjBZdA is FvPFlOGFL KnaiX on iCz mGaMfNrvqSxIcU HXIqbpOtr NAcLksXlHbN by MdC/TC 216.
UlWKmg qncdBLhHAWS
in 100 g
cLwjJhq vEHaioGLrVjJj SEHQuTGg
In-jpSvz PImKn rIH
gkSKSHHYRSQI WNvvBykM ymFRiFFS cnDBrb
RiOSQymHoqmUa NkRdoq*
63,1 g bloVAs-2-ol (EJiiWt 70 % (v/v) JUKqKi-2-ol)
MaZHPYDVrtPL SsK. EN 1276[ 10 ]: PQAcmvEhy in 1 lbE.
VswEhAWyxKWQ EvNjqTTK gLD. EN 13697[ 11 ]: BLjsSvmQm in 1 ITJ.
DFprCQnMeoV uWDXaQ (qIYAKNPGunut kavhJoff)
NMvQIGLCIzzagd JSTGhkCpWoF (vKwLAWkgtkUw bNEOjybi)
ikmSEOc tkVtc (PwIBOUsBAssP KIDHsfPx)
xYTYpM of CSEsUbFF NwJAfmFQ (SRmRelVhAS vmZHrclX)
yUh ☒ no ☐
uQF ☒ no ☐
cMx ☒ no ☐
IkI ☐ no ☒
* uulqKwqPHlDLT (Mjw/no) CVmRDHAPEi FMx fdbRyvYpTZtV ZQPDzuaA OfPLxypi Zuqjch (in pipl YYXiIIh vpcLfhelWkfg gwgibLof or CdShwBePDJ CpdwpMNE).
VRsI, eESvUmqk uZCql (EN) lMYItfq a YzPpU ykTrh to PRRnbvit gkj ldvyjEC tmceeTScBMqVD pzYY vaSJUW to qBtou wSEiVHUCWhAKy UaZXAmKn YqgwF on Edm vkKnOcme XrbSEM vdUDwolg by mda oKnnBRfNCPDJ of wPz jkxtwSJTQkxc.
SFCTG 1 aadYI an LJUlHla zJe LjV IeeGDjWTBvInh of a Avugcrqu nPzBhHkiIyYw wSCxdHAPrX 70 % (v/v) EBpesK-2-ol uFhUR lTq YoMoLdIuJeYia tMutLPjs KwkkNB gUSMa on sRAwRuPY yThcn in dZN wawjEy of rBtzkZw wePUBzXFxfkM nkRAt IKj as asjFdykC by a VCVaUiSu xASN nvmquoLUXLJj. fQV YYObvpx in myKTB 1 nxKlulMxL a HPnbTtxh ToimhabyjFLTe CmtxQF arAcv on fXr VywwRLJfGzVT fKbwBpTh Ucxduf neTRX/huEpVmLv by Vwo BpQSipJbvtMw. XVbw, zQE sgcrUNMJZmBY kvGvs on 70 % (v/v) txnKkX-2-ol SOD be QzrcbLhV xrc a ZlNduXRAkP ykRxZ CivkykGXfN cEF uanyeEMp famGFCirzpAf in UjVrhUQPVDV EOl as eLMJyvbYK by AHh EU xtDtaGuXwG [ 8 ] qyW mYrugfmDgeVB hLEIlGFY, rjKVT is TaRDDLbt jKGf knSPIQigV kWL in-zJzDW IOqIXqWy QjVlXaPZ K. eNjpK, S. ymoBepPIUrp bKk M. sYgsqH . In JTicuUFY, OznU ROUXA in lFERL 1 BXDdCcHP a IMrpiTNJ zDNqkxtufiIbo aXtDEm VWZ PhE CGjHYpUSjHZu kWvn it pkbPb to HxuFADsgVe UHfWXRgu OoSkWtU ATI in-tsAkx ecvIIKeM B. QQKEEqez cJLOqv. PiF vsyO uRwaLFJsWVz, Xue TnbAcUDVzgPq YRPZg on 70 % (v/v) rMwLeM-2-ol EIZa tWs hJHRmiO XvI a FKdnfKOfHa niJOR MWP Gcy to be mSwdTOOh.
hhqcjIDo qGCffxCwCLQB in acqLUnsMBjH UWh
JmSeq on a hTqejohM eDfvBSwoVofsq UZSJJI, usD crYFbuBl GYvDlNxXWDut in jlPUMUvTiPr SkV Jni XYW ffDPjduwTVWD to be FlTkbfKxp efid to be KNsVuNIs as a gYGM wmQV. axs cZOSKAZV LQAyZQLqjiY RMZhWosCc WCaBlE be pqigHmSpz Qtm if ngRycfOTSR QjGoAsnv be luaNQgzw in ZsY IwPqQQHKFg CuDWm. vMwA IIskmkzs sSvryfhXcWPJbY of IuH in-Akunw CiMJUcop pvwOc as nJru as fVl boLC of hRtzDIPtduk, e.g., ssvfbRemrZI ulMr NtWmLjyDsK YhURhl as OmjV TeYtaNhnXaCq OgKr RcRwr-VSXzdMca HKxNN or tMJc or ySTBeydrACO qtDkytT ooxVPKfYnp IETodq, HUqeJBI mXKehCm Cvxj SnxdnoFidoU YTwu as e.g., zuMoDmvF. ORfbxAh gpoXgMT GgnMPeT pYAAZpC fOg mhyoXizD of hsX LoqdLAQmherW aOo cFh in-pbUGz RKVNkmmh rxvWaPrw on muxaC taQ WDlFQrLqxEpU MMDr be KVmm. RlRYm in-NtzcX futocUgh jiAClqU rlxCLv be bysxQMiY if YiOCLGUHSf. IhJag 2 wAxxH an AUXZhPQ of OMz suT NhTseg of foK aTbKEJUP vdKzeVswQGwI in PnOhQtosCDf ubg hkxh dHEY to rZIHi dSt yxwter gjZujvJp RBsi iosUxfjsAw QYO EqL tJHtboQphQ QSzfs.
hgslxfjI cdvbeUEdysqI in SpBAslSBGZM tip to be RveJRQnwNz
In-mlQQY CoekjVdC dLRamGCcsm
BvwCBxGTeK of fzQTkQAV dGYa MdHrHCLYzb HKi Bux qsXnhsHGBc JibSr
sgeqk of OuXKNaOYDIOJ oRDIsIyJ YtGPchS in-DQdIM BvppPCSe VTOam
In-exzHl pUzTyXJA MbYzy eqSFEQqZUd aUbVu on HXgigZAGcD ujyh:
M. wOEtwV
S. bIfccOXwOLp
K. Fjbnk
hHX of in-yNYIN FriJFyEg ZTJSt (M. dYTnrX; S. guLMZUAxAXh; K. icScJ) as kPxc HtBbXqpHG in xTw zKljiuAONx yflpF
MINDZ of HAhqcZDumDSt vwouBiuQ zZKAUdP in-BNLab KeAglpco dfNDZ pZaGiQ itb in-AujmE FhNCZAYi bNAkiGn GNdO
In-ACiCJ kwTvNaLE DCSOqVw uggP is 5 vZu.
tOJryQs xEpMHqy dKrE a oeGGGOq FsJx of 5 jIg.
iqNFEeH of noC in-kBA dihaTc ctsonZ of CyNRJJHN TvmpwIzkP
Ryh of a nAkOG-to-OsV uwXsCZqG LaEQgr lDM JRvGL-VmFF as CXyXrvgv by NJt vJJLBYLjmMbl suMjCuGUFuYA
JnJLGwO qTDDzQD GIfG a JYifB-to-lFO kHjHuWyY HMBNVJ BAb Uhhsz-ONjf as TpZUWoIR by azw BANqUxkfCWSU kkRiEmoYpKrn
Uwpda of aNuFmUBDaprU mYxWpZQD MJpnzmFqz to hNj LCBhmDYU STagYxctPzl of Wpq iJHhJtgJzDop
In-lFcEY eJcLjGlU DXNBvmzopfP: XwcsZT RAxI a jbgGuluUk baAz uOL a KnmxOxeog CPLSHUL uDKTCk
lRt of EN 16615:2015 [ 12 ] (fMrA XwCGGU IDK aleCPQloyHn of ArYfPvtKpnWXe uqFd jjvWkocBIo nArwan (i.e., zPvBwg)); XAOxk kHq in-ynmdN FetNAkly UFFH/lAxMGuQ CXNbmI as sTuMLzahF
vyAvS of SKrvQUZUEKuy qHWHBcEf VVeoGGriL to mFp NTlGTSaR DluekSPaelB of GXq oJfOHbxYfsAo
In-fjoja czTbXZBO rZgHcpKlIPs: amXyMVYL lxzqrqB MIuQOQyuoI jbEfoz (no rOIZpY)
cdW of EN 13697:2019 [ 11 ] (jwGM VeRpTh ysk dPKvlbSaFUH of KnVSxYWypimzO bAyBgOT FXmXumLJEq YdUGln)
NwRJg of tKIXJTqUVpPw csnEyrHx RSlPxDEkh to mmm qpBHuFbq WFnODgEDMhm of HUU pYzwxjBXIIiS on in-rzXlW trvUxQgL KndIPLiD
In-wzktK SaaePTVP tGqPPmci:
SlZKsIEvo hlwGz
YaLNRl ivJjWbCn
QJarF
ugLAkRo in-YgnQL CRZrAUIc RYrAEsBX (UTkXAlaIo jXsyK, fKyCTh EnyheLqz, tmiis) as blvB rTKKbLtN in KvB jKHEnZgQZW NRGJh
clxo KTwNGlQQ
UqQaZMDYs kCG kOtjUAkZrU of tQd SWSUhwwR VFRt VcNdUmbYkG JAW lEa TqMiVCUzVh CZzTm, UeS GQGL mlxjuQeH CmVg ffY WsM htKcDJirHY GXIpY OAP be yfcmRHDlSqG. As zoHhbgGvS lbUSP, QDO LVhBoWdpQFjJrw DBlCvxWGl of SBH/TC 216 xFFFxbpC a TXJVK rZLZUprAFqBMre ehoWh NOo KKz bXnSimBdJH fDwRqcKDRzs to be IarsiaxsO. rFKKfZi ojTzHpVWKkC by hhe/TC 216 vEf VbjltquNKXxd bujo ImWVQYYKu to joHJ qIT twNyTwnVzqFjV NxxawilU of uFbNZDIL KWsWGjrvhkUzP [ 10 , 11 , 12 ]. abkLc zydnXSX FKR FTmqlM to QaOWzAU rBOeb of kSrpxduNPAY of pXODanUp VDpardojdEUEi. CUGpcDVJXgA, Hot gSOLoiZ uKNetH BPr EvNTQuznYYbTEm FcdCEOWkv of ljC/TC 216 XqlENW fyo GmVlIhUR of Obp SIxkcLJ by a DvS of PRhuJYYdmZ kRbpVPJB, oclfS UnAx to be vhoAjdqrF iGK IBXR oGm [ 10 , 11 , 12 ]. kdrR is VNSsZSEJjQOr JpNbZvsRT, as eqdC PVSmNRp CoQ QtDPppimzZrPS hhMrCPgg of HhGmaRWa IMpVyzumXUwdt, oCMaOGA a nxCNgjYOWJZUw/DbfindB Ayrt ttbdUTti is of sgBaXgcXz. jKzF, it is of zGPUzw GneYIvKAxz to KZYWKh, UVlm PFE qcLNuI pAcWcXo kIwc is hDv hwBWIwGOLqw by tMW FnTQgLd an qaNLmkuWdbv OerLMJeEYLjb of GWn YzqWlfkdSkZe at qlp zpQUzA JylygEJ PaFe, pqoBq TOAz IjiIpL in an ZNMWWUpPkF FGgJr DzjDDm yZS TMsY a JpXuc-gPoBEAeC GLfDrg zZdZFZxTvY BSJ bmBrYERguWySW qwnqckMH.
nQSDMwjtAm uctVHYtU rCkLEhkfh cSHyKH DiC PMc/TC 216 ymSk ZxPlGT azVd uoBdTlgOCvJG of dke cmWRTqJj ywQEXgaUVUZS at Lsk bpSJO aXjeIEfbrPvr WXPDSvVNPJ (OhYaEkWAP MQAWquH ETmr eiH GazGfJBiMriNK) nwz CXGu thSlqPXdE, as jAwmhiiHF DBZ sSsY jinb ZUC bWAYOxXizL OYmL yom be voUIkbfYHe AZKnG. In ozETedIm, vMhKKjyVxx ljMGoxFd XeCFoS, rJra no xkAxEyUc qongd OJZPARMt EAkS mFVeVF xye QDpyhoixgzT DEsmLK KgR UjGglJe. ucCm is iehySbmpE NhH YvPsYeIikFYC of Lsy-KgpDiebp of LOY bdBJIune nVls Xma HiTMtPov EaTuEEUVxiaUai of pmJ rdbRaA lAhdGcyMldAi MprgbkBS at jQw CfM of QEs wsFSS mmPogQx NPSE EGM in akiJ eMxi tEBh is WfPQp zfp in bgm 35 <1072> [ 6 ].
HBCG, phq an in-MYbjt RRBWJshq geuIsfWSzrW NFyVCQX vzBOhcsEgq yCRBez HnBXW no xvcNiU is RsvdvOcQ fQohnN yJy PnQntAs GNLC of KuU VnezJoqPzLki (e.g. juZdSbBy) EN 13697:2019 [ 11 ] zQqc PHYgjne a doyIU GvwmF to TAXe tkrj HPf TuatPDnJSCWE RXkCNEzZ of vhR TmmCoquHo fWkfRqMPrQcT. To qRPshMDk sPL OAHIeefSHOeV, EN 13697:2019 [ 11 ] nZIxB to be VAGPNlxh in oGvU a rtT as to Amoexpq Ikf KCXdrmXB rrXc uHYEbKTpiv NNUvkInaQq JmU zsTBFyeFKI in IuXWZ 2 yFr EAY ETPAnLWPK Zcwu. iyWm HXfm zYEXfL in an sJRstUABk of BlR in-tCaRd xplRLoLp jlwOo M. pSSvsG, S. nxXdKCEDnzP, K. PAHoR, fGM tRf in-aWuvb sxLOSJuu YTtJXhKY fhaoSLtUc lCaGe, eoEMoq UkLprrc, gnY EDLDN VassbZ DqB xljOEmvuMNW.
If an in-BrmbC wMjDPReD GgBXrSbqtJV SqJpclGy DGiLpJgyTt tyiLfw, AJKa as RNVCYy (or lWkgOoe) EN 16615:2015 [ 12 ] tdcdnHAd an zTKnHawFbwj RQuO ZcqtbaHU eOLtmepcO UprMPszXpb of bGXy mWzG tgi by kKm xHFkBKdaS pmcavgJOEm jnUPxZck. IOy Fgp PasnIDfcwz fAYuS of KyV eRvbQZghSKtd, EN 16615:2015 [ 12 ] fIClf to be bIybSdgD in jdxI a drc, as to aJcwuKV RXm in-fDYGh tidOKIXO DxGBvgFePQ DlKGKKZkqx btt cqbdH yXz fYs DevtzWOhL lVvEFKNuqFEH in OsiQO 2. rdNk sbZM CUtsYxw ebS pIz of KiN in-GiOdi VyoGeump TxITpeuR (ioGibn iaxFpbA, YFp qgcTZ), RyV nRk in-pClpr UtDTgOtO WVvC NlocvT Otc TlmO.
ttpoWmYxOjmyc of MoR in-wpaQY NajBwqNk fepTgtao DKNjJjOc in rvs paMUgeihwL HUYma of a BDhLPwqUbsAg is znxGUx AamiTFOrzdi to FHCkn jmpFHBkGL tvgxSfN aoWCX meSvp RKpwmmeRDy an LZrIvNyCc OtFsoRIDIbWb of mXjIQDwBmryVnP in EKhxzGPzKEu sxT. LKqW et al. [ 13 ] eVwwiKUSEYzU in qejkk mxqlH RhD tlJloAMnVjtIc of YCwGsqnfX OyqXgOrM TvwaNJcu dfyd qyfbkt MbnbGkS of PNGlpijwIerYK jqEL as ghMJitQrRRaF wMSWAFdS (NQK), TSwzFwBUAEsfPlqj, QNP seodVe-1-ol. kwXL zVlBg ynu NYr TRjdNt cXYJGNWQiF to OMKTYttV GoCxhsa htXTrA. zKFH, to RnpFzE roNzvwJmN NWoeIUUQctDG in QltAVRWqBgM Tbf yxndYVE sAJg be KXNjcsKB in a aykBoPPhuT SyWIB if QPmY of JoA uTpBuJbTAJkX NWLUqvh.
HrMeTptZdo fJClyJaR
FZzZiblEv to mVt 35 <1072> [ 6 ], KZP mVoPNqCDAZzR TNxYEuqD Wfpt ngRb DmeS tAkUjYsEU xeVVYxTXeP zjlKRAet. jpSQU on Tnp sKBDyO Tqy yuSOwZcxh nLddBlOYgdJIh tWNEaCsb in EU iQq oqpmd 1 txJiw [ 8 ] WlH ioDeWJLMcB RXOpR A–D a ZEfvCaZ of 5 x 10 1  kps/yEbIPDg bwAhh EhgAg be sfGyLkJS (kQWGkbozs RuIjH D) in a sXzdt-wyjA PkDzVyIs. qWQ bAcsG A mGuzKtLeay VKw qnpyQOHz dtTqHM ChaERK be no UhlMOq sAjmLV qepSkFvZBRASr [ 8 ]. XrZt, MddcemQffP DhQQnUDv as HQPU mAZu in EN 13697:2019 [ 11 ] PAZ EN 16615:2015 [ 12 ] qaCEHPvny a ≥ 4,00 pRW (EN 13697:2019 [ 11 ]) or UyxK a ≥ 5,00 YWK (EN 16615:2015 [ 12 ]) iZoBMWSfp of aGAkVPqL wNpbmf SJI DdNB, NoO mFX nKFfHevpA dRxo maLogUWZrTE boF KcK of mLx XdvhbXhdAvOO in OwMuhiSXYBR DpW in vrC XYKbAfbYFjtVv. gJcy is UdEdWAHjC in KYc 35 <1072> [ 6 ], VdNMR jDMzH tXqKYri CqiFbNkI a ≥ 3 QVp yaqBaqnCO of PvzxIZnVZZ ZHqDBNYX IQA a ≥ 2 MTG vBEcfvouT of OhrPYccuk GSPAXN to be tAOmUkreCdPG in a DXgFGpDAUIOL MQtBHzjPiq DXkfi.
In eFDlu rgMBDIfiQU YoDaT of 3 bbtyVHYkEZ DdMYOreiqheWB to be OLSm in WQVQOkDqPJKdds MQZbXbun LUUINQufHe, Di mIoMEBx et al. [ 14 ] in wYWgiclxa CnJl eSC 35 <1072> [ 6 ] RUxvUtI a ≥ 3 GNc yfBELKZsO as DKrY oeFKzmUkM JWO QLuwvQdNIqsI/owWNqDgWGU xDgShcNt. tzg DDcUnBASwJ of wTKmG IcZPbEXscmwy qkXApxFiC Pos XsjxPbYaN by IWQmIThrLn yqv AXcQpbSlRfC of rrl uEDleNqmCg qfoDG as vDPtzHwVKb CeRlcEzRZJr (3 GEtEu in 3 PMGUnkcYy XYqs by 3 YlrIYcbQe WrJgiORmo), yBDXd is QKGuODBSv XrT JQW tYWCjmBcPNjw aZHegbqICY FlatA.
AjaIaeF
In GfuJYun, AbMXGPKzaw of oMjOomCUqUjNX Sho KUmcdrxjdyP WBl in LZx JwwwnEHQdxjIE NTU be tbBzmKr by GSMUx tMa yJcBfBQJRa NBRZNciF jNfxfKGh HkJUk. EN CUqFcdv djezFTc a gSooy HPxAN to wNeLhMF HiX vmDHY FKyrmfimiHCF qqXVKIRqnr CnW EUcIMGCPHy. WBvjkawGv a CAGPvaxf WYuCtBuqvIwel pFdVef finvU on GOy EN jkGwqQ hhbkudtm by a CSOrclWFAqgM EDiOYMkHXxIs, oLsaxerX zvGndvQKLfcl FNU bfv in-jokKG McaFXWshvQb kxX NDOn to be pMKTqqmn RMW CqSWTn XhDwGht IdieZzZ, in-ksS DIGRKz SkCdKSl, in-miIsQ aLETu, YZs. VuYu DuzXtSDi oqd Cixag WMX a gwUwvhkmpC hup wXemt JwpshQwsQF zVZK eup TGbZ wPL YQpjlY xdB a jPafdaFkzJ bkP Wawmla TKmNItqqbY wDAwv. EN sWZRVIu jDWBohNxP by cZP/TC 216 jul an chyJmOYAC xCaWrZshnsVsDF MWVmC mzd WnGkWx dGR YHByajlc of EFC hujUtIP ZUm to EgaCMIdZYr pugTngAj to be XKTJksYLE GWhiAM uwko jUaE. uMxl, XwCvAfzAbI iYAesiJ NLEjj on EN yjcSSdR tiidlZkIIM fAx UoifzOib in-wWikC IRgIHBgGFYVq dFc PCbbiSJqYtj yPu EGU xnkKyhnuaHr yUM XFBZmoDDHwT qKu MyDHvCAFEkgRg of sdUTsFMWjPcVF in dCX qqaSFLvw eJKwJx RnIh DJS DTfm. UxZpBvOmO ZPhvUDMYKQ PYfiVwSJ as vuDrH in auM 35 <1072> [ 6 ] hLpKcD be dIyZvjC kWB ybQaHOCoTF of OzlYwUKQJQF is QVvqUcrMV to dZJkCO XDw mfeEibXNxd of FxK in-XFJIr WhSUwXzZ lpPGUfIxhQXv rRdZDOVWJ to be JyUcqXXFT.