YY/T 0987.1-2016 外科植入物 磁共振兼容性 第1部分:安全标记

YY/T 0987.1-2016 Implants for surgery—Magnetic resonance compatibility—Part 1:Safety marking

行业标准-医药 中文简体 现行 页数:13页 | 格式:PDF

基本信息

标准号
YY/T 0987.1-2016
相关服务
标准类型
行业标准-医药
标准状态
现行
中国标准分类号(CCS)
国际标准分类号(ICS)
发布日期
2016-03-23
实施日期
2017-01-01
发布单位/组织
国家食品药品监督管理总局
归口单位
全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
适用范围
YY/T 0987的本部分规定了医疗器械和其他物体在磁共振(MR)环境中的安全标记以提供安全提示信息。
注1: 除外科植入物外,对进入磁共振环境的其他医疗器械或物体,也可参考本部分进行安全标记。
注2: 如本部分与相关法规相冲突,优先使用法规的规定。

发布历史

研制信息

起草单位:
国家食品药品监督管理局天津医疗器械质量监督检验中心、微创医疗器械(上海)有限公司
起草人:
李佳、缪辉、李立宾、孙冰、施海峰
出版信息:
页数:13页 | 字数:24 千字 | 开本: 大16开

内容描述

ICS11.040.40

c35

YY/T0987.1-2016

Implantsforsurgery-Magneticresonancecompatibility-

Part1:Safetymarking

2016-03-23~:ffJ2017-01-01~tit€

YY/T0987.1-2016

titrf'f...······················••···········•••·•·········•·•···········...•••·•········•············••·····...·••·••...I

1Wf.ml.•.•.•••.•·•·••••••••••·•·•·•·•·•··•·•·•··•·••••••·•••.•..••••••••.•.•••.•••••.•...•.••••.•.•.•••••••••.•.1

2~!il[fJ:i'JIJTJJt1!f1

3*i!;f!J~){···························...l

4:ti){,faii!Zm·............................................3

s;t~Fic/f#;;···············································································································3

6'rlii~m:1~o~f~f.!l!.3

1MRf',T;ic.-E:!1'iB<J1s.~.•..······...······················...·········......3

ilH~A(~f4f'.fllf1*)Jjj!J!Il.••...•....•..••.......•..•......•....•..•...•.....•.•..•..••••.•..•...••.9

YY/T0987.1-2016

YYIT0987((:$'~f-H1LAtmI~.HU1ldft~tt))'lt:tJ~:;.r$?t:

-~1$)t:~~tff-ic:

-~2$?f,~J&f1lftniJ\~::tn.L

-~3$?t:l~1~1l.l~h'l'fft17~:

-m41m?rJJJ!ij!J&J?.:m~:nrt;

-m5fliS?t:~fiffi~iJ\J]~1ftto

;$:ffll)t::/gYY/T0987(l{Jtf11$?1-o

*$?ftliP.~GBIT1.12009~ftti:l!'N~Jll.]Jlljit?,!\[o

*1m7f{5!JFJl[ffr;J!;~tt~~-ASTMF2503-2008((~~i1iHf-mrlliff~-tiJU1ljt;{tf!.!j:p]i*i't~~~tffiic

~Jll.1fi))tlie1Mo

*$5}-.!:o:JASTMF25032008o<rt~*ft~J:F~Dr:

-*.-Tfffil1t.8~lfS:Jfl1riffi,::$:$?till"i1ffH-T:it!A~;!-t~lfm8~1t{1!!.~ff~~~BXtmi*o:tzo::$:$?t.!=]

1

;f!LX::7-;HJll.ffi(1fl~•{,t7ct~ffl$}Jll.1¥1}Jll.~o

-*.-T}Jt1rifl:'51fflJt14•*$?tf$TAfl'~*ft~Jf8'-Jif~~•l;.(~$l~!'lilo0tl.*?k{lf,iWJ~o0·l'ff

l£~9'1&~rr~2•··~r,HBImx14"9'1.Af*lfol~·(zor:

•fflYY/T0987.2ft~ASTMF2052-06:

•ffiYYIT0987.3{'t~ASTMF2119-07:

•fflYYIT0987.4f-t~ASTMF2182-lla;

•Jt1YY/T0987.51-t--MASTMF2213-06:

•fflGBIT2893.1-2004f-t~ISO3864-1:2002o

-*.3JfiGBIT2893.1-2004i!H~Arpfi<J*fi?tft:f*:

-JBIIJ~ASTMF2503-2008rp~8.o

iWtl:~::$:Jt{lj:00~®j};]~11I~¥!Y:&-i.?fijo.<$:-Jt{tB'~.Dt1tJfJLf~~7¥.f.§iH~']1.!~-wfiJfi<J!It{fo

::$:$?1-~~-ft~~~~-fi-~~-ffio

::$:$?1-Ff:J~~7~f-Hii:A1JI1fll~JHf~~~~tff-11£1-t**~93_~(SACITC110)~3r::lo

*$?tit?,W-if!f.iL:~Zttrfb~~rfn~'fifWJ!!IM:=Kf-'f!I~H?'H~mt:li~~~~9'1•L',W£gu12iff~tiJX(J:#iJ)

fl'll&.z.~~L

*1m?-!-±JH~1i!A:'$-f:L~Jttt-,$ft~,f,r]1Of<,fiili#iJdl$o

YY/T0987.1-2016

9~f4*iA~~~1~*~'11

~1$~:~~*~ic.

i±1:F•HH4ttiA!1m~~.~tHrAfti.~.J~~~tt£7i0JtIll!!1<ff~~t!tX!!X:!I'A11'.11!.ar~t·-1•i\i;'J}ill1i'~~f,J;ie

i±2,~n-1>i\il1}'H11..X::il..k',HUII1r~.fX:Jtrl!JH1HU~~k'

..$:1\i)7ti'l~El(J~:

<I>lti.Xllffi~.iti:A:vtR}i(.I-Jl(J~!fPJ14-:'fl:lk~f,f-ic~~tJVf-i~~W:tr.:VI.ff.l-;t"R;MI'H<~:

<2>ifix.f,f-icr_.:z~~1'1%~,\l!,o

tEttA1ml11tJ!t~fi~t~f·.fi1.~f,f.icffBt:!f::...fJl;!;%1'19o~-1~flliilt~f,J;icflit,ill~X.{£fiT-~fOWJ.A.f"i.f

,E!,-Fkill:h.f,f-ii!

~-*~~M~~~~~~-.~~~~~~~~~-.

,-j;:1\1)7}*JIJfJ~~'Ff'(L{:z;IJi](J~fifl.ft'-r~ffE..j";Ij~rl,(J~fl:fli{x11:1-J~~-~-

1s:l1iS7t}f:~~kf\;1*"1Mffri!Y&JIJD~~:fi~"£p:;JJ!ilHr~~~.Uni!~j$~-~X~JlJ11~69~"£fiiJ.Wou!H

JL::m~n~'!X.~&~~~~~r'i1•t:JJJt.:f.El.tiJIJlilToJl~'1fJJ~RffilJrr9ili~Jn..12*tiFHHlJPf!!t~JJr-ff0

r9tlxf'F~T-~Jcf'l:(l~~Jli:li~·;f;"ilf~MQft-:&tl:ElW!Cf<J~ImX:1tf,fX.i'i:l:lWIn9miJfs:ll!J!J=f<1>:x

f't-.fL~~71rr'WIo~?,IJUJJ:.f'f.:l'tJtWTllF.i*(~f;lfliJf1fl'fJ~i&¥->~fflr;fs:Jcfl

GHT2893.120f~lm~~-1C~@.;f01C~fiftiit~l"&"iS7t:f.ft.I-JjJi)ff1li~~:tf:>(~rp:fe~f,f-

,.~(J~i5htIJR!)!lj<ISO36II:02.MOD>

YY/T0987.29~~!1iA~fi1!JUJiUft~t1:~2ftiS*:!eU!£f,';~1JiA~~1fW

YY/T0987.3>'l·f:HnA!lmrtl~i1iUf~f'.l.:~3Bit:-tltf'OJ~JH..flt"nit

YY/T0987.491·-fHnA!WJ.ft411Uft~fi'#4-l-ffl\7!-:M~iHAiA~~Jiil::

YYIT0987.59~-fH.O:A!fPJftPJ.J~ffi~~t'i;-jf!:'S"$7}:MI.flHUEiA!J~Jii!

3.1

1i?;~hazard

if{£i'Jqffi:p~l~0

3.2

!lo/J-1*item

llffi~~-m'AMR.fifJJlo~~fi~HIX!!X:;l:tft!!.!lmf4'o

YY/T0987.1-2016

3.3

~!&{U31Jmagneticallyinduceddisplacementforce

1•!.-'f£1l!J~Jl~:J:mrpB9~t't#Jf*~¥1JA91Joi~tJ0~3&~tt#Ji*{E~fft:J:fJrftft4Jo

3.4

~~iB.~magneticallyinducedtorque

ffif~~~~•tt•u.mF~~m~o~m~~-tt~i*~-r~mw~••n~m~o

3.5

ii!115'H~5~/Jt~ii!lilWIfmagneticinduction.magneticfluxdensity

.iifi:i18:J:mY:,ff--~!f!iRi:](.Jifr~f1::JlltJE)tS.iffi1l:ft:(£W:.~rol1mrpf=1::(!~~1::Ft!ij]~i~!IJf.tiltil]B'~IW!!m

5!i!Jfo·,ljl··.~neB~/.11~!i!Jlf!J\t1=I~H~5li'd.fBm:v1R~Yti'Y.Jrffti~fir!:J:msleJ!t•~£;l:l•ttlf:il:59t#WHi'T.<T)o

tift111flU~ji!j,f=i*~IF<tillB).?.:litJfUflf*>tVf-<~IID>•

3.6

~#~magneticresonance:-"1R

ffi~-~~~-~&~D~~-~-~~~ffi-~o

3.7

ii!l;l:t~(MR)$ijlmagneticresonance(MR>environment

MI<~tff~0.5mTC5G)~pqi¥J£fal,@t~MR·tHI1f:X.ffl]~tl<H1~1'=:t1f.£fBJ10.5mT!X§.~tE

tt:tV:~Jt17'1M.~1'~faJ/.11t!A!.-:R·~~<MR>ffiJ&o

3.8

ii!1#~~t1tmagneticresonancesystem

\1R~tfeMRSystem

•Affii.Q:1ft,fflf't<&.W.Sl/J~,t£;t1J;fO~7VrtfjtJ;i.~J1)fll~ri.il!:AIX<~nmf~>A4iff1:-.

3.9

MR~~~f!f~~MRconditional

~~~MR~~;fO~~It1=~#~~F~E~~~I¥J~i*oB·~~~~MR~~~m·•~

ft,lir.ftm~foJW/Jt,M;Zi.!JMI'DJ~1t$<dBdt>,M'*!<RF>:J:mJ:JlJ.t!j~P&_~i~<SAR).1~l!tz9~•.ifllftiE{!].

.Jt.~f*u4t.HJ+;f!.J~o

3.10

MR~~MRsafe

{EMffMR~m~B~f=~~-~~~·~0

it:MI<1i:3tAg~!.fi:§M~!:ff1i!,1~ilfttA~~l.fi:tm~t-4ff'rlFJill..uf1tJ.~H~}_Illif:r1ii~~'Z'*f)(t{l:lilflIE~I*:ll:'iii'-:h

MR'1(~.

3.11

-"1RfBI!i~Runsafe

.{[JiJTnMRfif..IJ!~~JftJbt~!;{.}'i'J~~f*o

it:Ml<Iii:~i¥J~f*§1fill!ti'1~!*.~0~lilitl(t(j!PI7J':';.

3.12

~fift~medicaldevice

:t1J~f{fja~ffiWJm.iai~-:RF:YIJ13a'~H1T-A~A4•'Gi~.!¥!-~!!!f;f!mB.Hll1tf~mo~.1!J.1iS1!1!fflJifr·J;ftxf'luP>J

u4{IfnJf:X.6~,i2:&-,~~~,HH!!X1tJtft!!.!t1Atilt•~~!dl'r'~~,

~X~ti<iA~~lt!T'f§i~'%;:!P'ibffB.X.ft·!~~:

fjj~1¥Jit$T,~tft,ififf,rlWf!'X-!HH'~~:

Riff~