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Iso 7165 2017
Iso 7165 2017
GITHRICTGJICN G]J
]TCIDCRD 63?8
Tlgrd hdgtgji
2536-56
Rhohrhimh iu`bhr
G]J 63?812536(H)
© G]J 2536
Urjvnäsigifshxh`pncr / Urhvghw
G]J 63?812536(H)
G]J 63?812536(H)
Mjithits Ucfh
Ojrhwjrd ........................................................................................................................................................................................................................................ vg
3 ]mjph ................................................................................................................................................................................................................................. 3
2 h rhohrhimhs...................................................................................................................................................................................... 3
Ijr`ctgvh
Ijr`ctgv
= Thr`s cid dhgigtgjis ..................................................................................................................................................................................... 3
4 Mncssggmctgji jo hxtgifugslhrs ............................................................................................................................................................... 4
8 Hxtgifugslgif `hdgc, prjphnncits cid gnngif rhqugrh`hits................................................................................... 4
8.3 Hxtgifugslgif `hdgc........................................................................................................................................................................... 4
8.3.3 Mcrbji dgjxgdh................................................................................................................................................................... 4
8.3.2 Mnhci cfhits ......................................................................................................................................................................... 4
8.3.= Ujwdhrs ................................................................................................................................................................................... 4
8.3.4 Ojc` mjimhitrcths......................................................................................................................................................... 8
8.3.8 Vcthr-bcshd
Vcth r-bcshd cfhits....................................................................................................................................................... 8
8.2 Urjphnncits ................................................................................................................................................................................................. 8
8.= Ognngif rhqugrh`hi
rhqugrh`hits ts........................................................................................................................................................................... 8
8.=.3 Ognn dhisgty ............................................................................................................................................................................. 8
8.=.2 Ognngif tjnhrcimh................................................................................................................................................................ 8
8.=.= Mlcrfhs..................................................................................................................................................................................... 8
? Urhssurh rhqugrh`hits ojr njw-pr njw-prhssurh hssurh hxtgifugslhrs............................................................................................. ?
?.3 Thst prhssurh............................................................................................................................................................................................. ?
?.2 @gig`u` burst prhssurh ............................................................................................................................................................... ?
6 Fhihrcn jphrctgif phrojr`cimh rhqugrh`hits.................................................................................................................... ?
6.3 Jphrctgif th`phrctur
th`phrcturhs hs.................................................................................................................................................................. ?
6.2 @gig`u` hoohmtgvh dgsmlcrfh tg`h cid bunk rcifh jo dgsmlcrfh ................................................................. ?
6.2.3 Mncss C-rcthd hxtgifugslhrs .................................................................................................................................... ?
6.2.2 Mncss B rcthd hxtgifugslhrs..................................................................................................................................... 6
6.2.= Bunk rcifh.............................................................................................................................................................................. <
6.= Rhsgstcimh tj th`phrctur
th`phrcturh h mlcifhs ...................................................................................................................................... 7
6.=.3 Rhqugrh`hits ..................................................................................................................................................................... 7
6.=.2 Thst `htljd.......................................................................................................................................................................... 7
6.4 Rhthitgji jo mlcrfh............................................................................................................................................................................. 7
6.4.3 Rjutgih mlhmks................................................................................................................................................................... 7
6.4.2 Rhthitgji jo mlcrfh ojnnjwgif pcrtgcn dgsmlcrfh ............................................................................... 35
6.4.= Njif-thr` nhckcfh thst............................................................................................................................................ 33
6.8 @hmlcigmcn rhsgstcimh.................................................................................................................................................................... 33
6.8.3 Rhsgstcimh tj g`pcmt.................................................................................................................................................. 33
6.8.2 Rhsgstcimh tj vgbrctgjis ......................................................................................................................................... 32
6.? Rhsgstcimh tj mjrrjsgji ................................................................................................................................................................ 3=
6.?.3 Hxthricn mjrrjsgji thst ............................................................................................................................................ 3=
6.?.2 Githricn mjrrjsgji thst ojr hxtgifugslhrs usgif wcthr-bcshd `hdgc................................ 34
6.6 Tcppgif thst (pjwdhr hxtgifugslhrs jiny)................................................................................................................... 34
6.6.3 Rhqugrh`hits .................................................................................................................................................................. 34
6.6.2 Thst cppcrctus ................................................................................................................................................................. 34
6.6.= Thst `htljd....................................................................................................................................................................... 36
6.< Githr`gtthit dgsmlcrfh thst........................................................................................................................................................ 3<
< Uhrojr`cimh rhqugrh`hits ojr thst grhs .................................................................................................................................3<
<.3 Rctgif sugtcbgngty ojr tlh vcrgjus mncsshs jo grh ...................................................................................................... 3<
<.3.3 Mncss C .................................................................................................................................................................................... 3<
<.3.2 Mncss B .................................................................................................................................................................................... 37
<.3.= Mncss M..................................................................................................................................................................................... 37
<.3.4 Mncss D.................................................................................................................................................................................... 37
<.3.8 Mncss O..................................................................................................................................................................................... 25
<.2 Thst grhs — Fhihrcn ........................................................................................................................................................................ 25
G]J 63?812536(H)
G]J 63?812536(H)
Ciihx O (ijr`ctgvh) Mnhci Cfhit LOM-2=?oc — Hxtgifugslgif cfhit plysgmcn prjphrtghs prjphrtghs ......................62
Bgbngjfrcply ............................................................................................................................................................................................................................. 68
G]J 63?812536(H)
Ojrhwjrd
G]J (tlh Githrictgjicn Jrfcigzctgji ojr ]tcidcrdgzctgji) gs c wjrndwgdh ohdhrctgji jo ictgjicn stcidcrds
bjdghs (G]J `h`bhr bjdghs). Tlh wjrk jo prhpcrgif Githrictgjicn ]tcidcrds gs ijr`cnny mcrrghd jut
tlrjufl G]J thmligmcn mj``gtthhs. Hcml `h`bhr bjdy githrhsthd gi c subahmt ojr wlgml c thmligmcn
mj``gtthh lcs bhhi hstcbngslhd lcs tlh rgflt tj bh rhprhshithd ji tlct mj``gtthh. Githrictgjicn
jrfcigzctgjis, fjvhri`hitcn cid iji-fjvhri`hitcn, gi ngcgsji wgtl G]J, cnsj tckh pcrt gi tlh wjrk.
G]J mjnncbjrcths mnjshny wgtl tlh Githrictgjicn Hnhmtrjthmligmcn Mj``gssgji (GHM) ji cnn `ctthrs jo
hnhmtrjthmligmcn stcidcrdgzctgji.
Tlh prjmhdurhs ushd tj dhvhnjp tlgs djmu`hit cid tljsh githidhd ojr gts ourtlhr `cgithicimh crh
dhsmrgbhd gi tlh G]J/GHM Dgrhmtgvhs, Ucrt 3. Gi pcrtgmuncr tlh dgoohrhit cpprjvcn mrgthrgc ihhdhd ojr tlh
dgoohrhit typhs jo G]J djmu`hits sljund bh ijthd. Tlgs djmu`hit wcs drcothd gi cmmjrdcimh wgtl tlh
hdgtjrgcn runhs jo tlh G]J/GHM Dgrhmtgvhs, Ucrt 2 (shh www
www.gsj
.gsj.jrf/
.jrf/dgrhmtgvhs
dgrhmtgvhs).
).
Ctthitgji gs drcwi tj tlh pjssgbgngty tlct sj`h jo tlh hnh`hits jo tlgs djmu`hit `cy bh tlh subahmt jo
pcthit rgflts. G]J slcnn ijt bh lhnd rhspjisgbnh ojr gdhitgoygif ciy jr cnn suml pcthit rgflts. Dhtcgns jo
ciy pcthit rgflts gdhitgghd durgif tlh dhvhnjp`hit jo tlh djmu`hit wgnn bh gi tlh Gitrjdumtgji cid/jr
ji tlh G]J ngst jo pcthit dhmncrctgjis rhmhgvhd (shh www
www.gsj
.gsj.jrf/
.jrf/pcthits
pcthits).
).
Ciy trcdh ic`h ushd gi tlgs djmu`hit gs giojr`ctgji fgvhi ojr tlh mjivhighimh jo ushrs cid djhs ijt
mjistgtuth ci hidjrsh`hit.
Ojr ci hxpncictgji ji tlh vjnuitcry icturh jo stcidcrds, tlh `hcigif jo G]J sphmggm thr`s cid
hxprhssgjis rhncthd tj mjiojr`gty csshss`hit, cs whnn cs giojr`ctgji cbjut G]J‗s cdlhrhimh tj tlh
Vjrnd Trcdh Jrfcigzctgji (VTJ) prgimgpnhs gi tlh Thmligmcn Bcrrghrs tj Trcdh (TBT) shh tlh ojnnjwgif
XRN1 www
www.gsj
.gsj.jrf/
.jrf/gsj/
gsj/ojrhwjrd
ojrhwjrd.lt`n
.lt`n..
Tlgs djmu`hit wcs prhpcrhd by Thmligmcn Mj``gtthh G]J/TM 23, Hqugp`hit ojr grh prjthmtgji cid grh
gfltgif,, ]ubmj``gtthh ]M 2, @ciuc
gfltgif @ciucnny
nny trcispjrtcbnh
trcispjrt cbnh grh hxtgifugslhrs.
hxtgifugslhrs.
Tlgs tlgrd hdgtgji mcimhns cid rhpncmhs tlh shmjid hdgtgji (G]J 63?812557), wlgml lcs bhhi thmligmcnny
rhvgshd.
— thst
thstss usgif pjncr sjnvhits
sjnvhits cs c ouhn ojr wcthr-bcshd
wcthr-bcshd grh hxtgifugslhrs
hxtgif ugslhrs lcvh bhhi cddhd.
GITHRICTGJICN ]T
]TCIDCRD
CIDCRD G]J 63?812536(H)
3 ]mjph
Tlgs djmu`hit sphmgghs tlh prgimgpcn rhqugrh`hits githidhd tj hisurh tlh scohty, rhngcbgngty cid
phrojr`cimh
phrojr`cimh jo pjrtcbnh grh
g rh hxtgifugslhrs.
hxtg ifugslhrs.
Gt gs cppngmcbnh tj c ounny mlcrfhd hxtgifugslhr lcvgif c `cxg`u` `css jo 25 kf. ]ubahmt tj njmcn
cmmhptcimh, cppngmctgji mci bh hxthidhd tj hxtgifugslhrs lcvgif c tjtcn `css jo up tj 28 kf wlhi ounny
mlcrfhd.
2 Ijr`ctgvh rhohrhimhs
Tlh ojnnjwgif djmu`hits crh rhohrrhd tj gi tlh thxt gi suml c wcy tlct sj`h jr cnn jo tlhgr mjithit
mjistgtuths rhqugrh`hits jo tlgs djmu`hit. Ojr dcthd rhohrhimhs, jiny tlh hdgtgji mgthd cppnghs. Ojr
uidcthd rhohrhimhs, tlh ncthst hdgtgji jo tlh rhohrhimhd djmu`hit (gimnudgif ciy c`hid`hits) cppnghs.
G]J 35?3
35?37-212533,
7-212533, Rubbhr cid pncstgms ljshs cid tubgif — @hcsurh`hit jo nhxgbgngty cid stgooihss — Ucrt
21 Bhidgif
Bhidgif thsts ct sub-c`bghit th`phrcturhs
G]J 33?53, Ogrh gfltgif — Vlhhnhd grh hxtgifugslhrs — Uhrojr`cimh cid mjistrumtgji
G]J 3=5?3-3, Ulysgmcn cid `hmlcigmcn prjphrtghs jo wjjd — Thst `htljds ojr s`cnn mnhcr wjjd sphmg`his
— Ucrt 31 Dhthr`gictgji jo `jgsturh mjithit ojr plysgmcn cid `hmlcigmcn thsts
G]J cid GHM `cgitcgi thr`gijnjfgmcn dctcbcshs ojr ush gi stcidcrdgzctgji ct tlh ojnnjwgif cddrhsshs1
— GHM Hnhmt
Hnhmtrjphdgc1
rjphdgc1 cvcgncbnh ct lttp1//
lttp1//www
www.hnhmtrjphdgc
.hnhmtrjphdgc.jrf/
.jrf/
=.3
bctml
frjup jo tlh sc`h prjdumts `cdh ji tlh sc`h prjdumtgji ngih usgif tlh sc`h njt jo `cthrgcns durgif
jih prjdumtgji slgot
=.2
bunk rcifh
rcifh jo tlh hxtgifugslhr wlhi 85 % jo gts `hdgc lcs bhhi hxphnnhd
G]J 63?812536(H)
=.=
mlcrfh jo hxtgifugslhr
`css jr vjnu`h jo tlh hxtgifugslgif `hdgu` (=.7=.7)) mjitcgihd gi tlh hxtgifugslhr hxprhsshd gi vjnu`h
(ngtrhs) ojr wcthr-bcshd hxtgifugslhrs cid gi `css (kgnjfrc`s) ojr jtlhr hxtgifugslhrs
=.4
mncssggmctgji jo grhs
frjupgif
frjupgi f jo grhs ji tlh
t lh bcsgs jo tlh mlcrcmthrgstgms cs fgvhi gi =.4.3 tj =.4.8
=.4.3
mncss C
givjnvgif sjngd `cthrgcns, usucnny jo ci jrfcigm icturh, gi wlgml mj`bustgji ijr`cnny tckhs pncmh wgtl
tlh ojr`ctgji jo fnjwgif h`bhrs
=.4.2
mncss B
givjnvgif ngqugds jr ngquhgcbnh sjngds
=.4.=
mncss M
givjnvgif fcshs
=.4.4
mncss D
givjnvgif
givjnvgif `htcns
=.4.8
mncss O
givjnvgif mjjkgif `hdgc (vhfhtcbnh jr cig`cn jgns cid octs) gi mjjkgif cppngcimhs
=.8
mnhci cfhit
hnhmtrgmcnny iji-mjidumtgvh fcshjus jr vcpjurgzgif ngqugd grh hxtgifugslcit tlct djhs ijt nhcvh c
rhsgduh upji hvcpjrctgji
Ijth 3 tj hitry1
hitry 1 Ojr mjidumtgvh
mjidumtgvh prjphrtghs cid c`juit jo rhsgduh, shh Ciihxhs M,
M , D, H cid O.
=.?
mj`pnhth dgsmlcrfh
pjgit gi tlh dgsmlcrfh jo ci hxtgifugslhr wlhi tlh githricn prhssurh lcs hqucngzhd wgtl tlh hxthricn
prhssurh, wgtl tlh vcnvh mjitrjn bhgif khpt ounny jphi
=.6
dgspjscbnh
dgspjscbn h hxtgifugslhr
iji-rhmlcrfhcbn
iji- rhmlcrfhcbnh h hxtgifugslhr
hxtgifugslhr dhsgfihd ijt tj bh rhmlcrfhd gi tlh ghnd jr ct tlh ocmtjry, but githidhd tj bh dgsmcrdhd
cothr ush
=.<
hoohmtgvh dgsmlcrfh tg`h
tg`h orj` tlh mj``himh`hit jo dgsmlcrfh jo tlh hxtgifugslgif `hdgu` (=.7 =.7)) ct tlh ijzznh tj tlh fcs
pjgit ((=.32
=.32)) jo tlh dgsmlcrfh strhc` wgtl tlh mjitrjn vcnvh ounny jphi
=.7
hxtgifugslgif `hdgu`
substcimh mjitcgihd
mjitcgihd gi t lh hxtgifugslhr tlct mcushs hxt gifugsl`hi
gifugsl`hitt
G]J 63?812536(H)
=.35
gnn dhisgty
`css gi kgnjfrc`s jo hxtgifugslgif `hdgu` ((=.7
=.7)) phr ngtrh jo mjitcgihr vjnu`h cs gtthd ojr ush, mj`pnhth
wgtl vcnvh cid githricn gttgifs
=.33
grh hxtgifugslhr
cppngcimh mjitcgigif ci hxtgifugslgif `hdgu` ((=.7
=.7)) tlct mci bh dgsmlcrfhd cid dgrhmthd jitj c grh by
tlh cmtgji jo githricn prhssurh
Ijth 3 tj hitry1
hitr y1 Dgsmlcrfh `cy bh cmlghvhd by
=.32
fcs pjgit
pjgit wlhrh tlh `hdgu` dgsmlcrfh mlcifhs orj` prhdj`gicthny ngqugd `hdgu` tj prhdj`gicthny
hxphnncit fcs
=.3=
njwhst jbshrvcbnh cdvhrsh hoohmt nhvhn
NJCHN
njwhst mjimhitrctgji ct wlgml ci cdvhrsh plysgjnjfgmcn jr tjxgmjnjfgmcn hoohmt lcs bhhi jbshrvhd
=.34
njw prhssurh hxtgifugslhr
hxtgifugslhr lcvgif c shrvgmh prhssurh, ps, ijt hxmhhdgif 28 bcr
=.38
`cxg`u` shrvgmh prhssurh
p`s
hqugngbrgu` prhssurh dhvhnjphd gi c ijr`cnny mlcrfhd cid prhssurgzhd hxtgifugslhr tlct gs mjidgtgjihd
ct ?5 µM ojr ct nhcst 3< l
=.3?
pjrtcbnh grh hxtgifugslhr
grh hxtgifugslhr ((=.33
=.33)) tlct gs dhsgfihd tj bh mcrrghd cid jphrcthd by lcid cid tlct, gi wjrkgif jrdhr,
lcs c `css jo ijt `jrh tlci 25 kf
Ijth 3 tj hitry1
hitry 1 ]ubahmt tj njmcn cmmhptcimh, hxtgifugslhrs lcvgif c tjtcn
tjtc n `css jo up tj 28 kf wlhi ounny mlcrfhd
crh phr`gtthd.
=.36
prhssurh fcufh
dhvgmh tlct sljws tlh prhssurh gi tlh myngidhr cid tlh jphrctgif rcifh jo tlh hxtgifugslhr bcshd ji tlh
jphrctgif th`phrcturh-prhssurh rhnctgjislgp
=.3<
prhssurh gidgmctjr
dhvgmh tlct sljws tlct tlh hxt gifugslhr gs prhssurgzhd ct gts rcthd hxphnncit fcs prhssurh
=.37
prjphnncit
iji-nc``cbnh mj`prhsshd fcs ushd tj hxphn tlh hxtgifugslgif `hdgu` ((=.7
=.7))
G]J 63?812536(H)
=.25
rhmlcrfhcbnh
rhmlcrfhcbn h hxtgifugslhr
hxtgifugslhr dhsgfihd tj bh rhmlcrfhd cothr ush
=.23
shrvgmh prhssurh
ps
hqugngbrgu` prhssurh dhvhnjphd gi c ijr`cnny mlcrfhd cid prhssurgzhd hxtgifugslhr mjidgtgjihd ct
25 µM ojr ct nhcst 3< l
=.22
wht mlh`gmcn
wcthr-bcshd mlh`gmcn cfhits tlct gimnudh, but crh ijt ng`gthd tj, cquhjus sjnutgjis jo pjtcssgu` cmhtcth,
cmhtct h,
pjtcssgu` mcrbjicth, pjtcssgu` mgtrcth jr mj`bgictgjis jo tlhsh `cthrgcns
4 Mncssggmctgji jo hxtgifugslhrs
Hxtgif ugslhrs slcnn bh mncssgghd
Hxtgifugslhrs mncssgghd by tlh t yph jo hxtgifugslgif
hxt gifugslgif `hdgu` tlct tlhy mjitcgi. Ct prhshit,
prhshit, tlh
`cgi mncsshs jo hxtgifugslhrs
hxtgifug slhrs crh
— wcthr-bcshd,
— pjwdhr,
Tlhsh mncsshs jo hxtgifugslhrs `cy bh ourtlhr sub-dgvgdhd. Ojr hxc`pnh, wcthr-bcshd hxtgifugslhrs
`cy mjitcgi purh wcthr jr wcthr wgtl cddgtgvhs, suml cs whttgif cfhits, vgsmjsgty-gimrhcsgif cfhits,
nc`h rhtcrdcit, ojc`gif cfhits, wht mlh`gmcn, htm. Vcthr-bcshd hxtgifugslhrs, gimnudgif ojc`,
mjitcgigif dgoohrhit typhs jo orhhzgif-pjgit dhprhsscits slcnn bh trhcthd cs shpcrcth cid dgstgimt
`jdhns ojr tlh grh rctgif thsts cid ojr tlh purpjsh jo thstgif tlh rcifh jo tlh jphrctgif th`phrcturhs,
hnhmtrgmcn mjidumtgvgty, htm. Cnn jtlhr rhqugrh`hits rhnctgif tj tlh dhsgfi cid mjistrumtgji jo wcthr-
bcshd hxtgifugslhrs crh cppngmcbnh tj cnn `jdhns, grrhsphmtgvh jo mjithits.
IJTH Gi sj`h mjuitrghs, tlh `ciuocmturh cid ush jo mnhci cfhits crh rhfuncthd by tlh @jitrhcn Urjtjmjn jr
by ictgjicn rhfunctgjis.
8.3.= Ujwdhrs
Ujwdhrs ushd gi hxtgifugslhrs slcnn mj`pny wgtl G]J 6252, wgtl tlh hxmhptgji jo pjwdhrs ojr ush ji
mncss D grhs.
G]J 63?812536(H)
Ojc` mjimhitrcths ushd gi hxtgifugslhrs slcnn mj`pny wgtl tlh cpprjprgcth pcrt jo G]J 625=.
IJTH Tlhrh gs ij Githrictgjicn ]tcidcrd mjvhrgif iji-ojc`gif cddgtgvhs sj`htg`hs cddhd tj wcthr tj
prjdumh citgorhhzh, whttgif jr jtlhr sphmgcn mlcrcmthrgstgms. Ljwhvhr, suml hxtgifugslhrs crh gimnudhd gi tlh
mcthfjry jo wcthr-bcshd hxtgifugslhrs.
8.3.8 Vct
Vcthr-bcshd
hr-bcshd cfhits
Vlhi tlh hxtgifugslgif cfhit lcs c pL hxmhhdgif 7,8, c wcrigif stcth`hit slcnn bh rhqugrhd ojr tlh
hxtgifugslhr ic`hpncth (shh 35.2
35.2).
).
8.2 Urjphnncits
Tlh prjphnncits ojr stjrhd prhssurh cid mcrtrgdfh-jphrcthd hxtgifugslhrs slcnn bh cgr, crfji, mcrbji
dgjxgdh, lhngu` jr igtrjfhi jr `gxturhs jo tlhsh fcshs lcvgif c `cxg`u` dhw-pjgit jo −88 µM. Iji-
nc``cbnh trcmhrs `cy bh cddhd tj tlh prjphnncit tj ocmgngtcth nhckcfh dhthmtgji. Tlh phrmhitcfh jo tlh
trcmhr slcnn bh gidgmcthd by tlh `ciuocmturhr cid vhrgghd by tlh thst ncbjrctjry, wgtl tlh hxmhptgji
tlct gt gs ijt ihmhsscry ojr tlh prjphnncit ojr stjrhd-prhssurh, wcthr-bcshd hxtgifugslhrs tj `hht tlh
cbjvh dhw-pjgit.
c) wcthr-bcshd hxt
hxtgifu
gifugslhr1
gslhr1 +5 % −8 % by vjnu`h;
b) pjwdhr hxt
hxtgifug
gifugslhrs1
slhrs1
— ≤3 kf ij`gicn
ij`gicn mlcrfh, ³8 % by `css;
— ≨= kf ij`gicn
ij`gicn mlcrfh, ³2 % by `css;
8.=.= Mlcrfhs
— wcthr-bcshd1 2 n, = n, ? n, 7 n;
— pjwd
pjwdhr1
hr1 3 kf, 2 kf, = kf, 4 kf, ? kf, 7 kf, 32 kf;