Tiêu chuẩn iso 07151 1988 scan

ISO mater s of ele tr ote h ical stan ar dizatio.. Surgical in tr ume ts.. 0 International O ankation for Stan ar dk ation, 198... Members of IEC a nd ISO maintain re isters of c rr entl

INTERNATIONAL STANDARD

In tr ume ts aric l&, n n tr an han ts - Spkifica tio s g&Grale

et meth d s d’e sai

19 8-12-01

Refere ce numb r

For ew or d

ISO (h Inter natio al Or ganizatio f or Stan ar dizatio ) is a w or l w id f ed r a tio of

natio al Stan ar ds bo ie (ISO member bo ie ) T he w ork of pr epr i g Inter natio al

bo y inter este in a s bje t f or w hic a te h ical c m ite has be n e ta ls e has

t he rig t to be r epr es nte o that c m ite Inter natio al or ganizatio s, g v er n-

me tal a nd n n-g v er nme tal in lais n w ith ISO, als tak pr t in t he w or k ISO

mater s of ele tr ote h ical stan ar dizatio

Dr af t Inter natio al Stan ar ds a dopte by t he te h ical c m ite s are circ late to

t he member bo ie f or a pr ov al bef ore th ir ac eptan e as Inter natio al Stan ar ds by

th ISO Co n i T he ar e a pr ov ed in acor dan e w ith ISO pr oc d r es r eq irin a t

least 75 % a pr ov al by th member bo ie v otin

Surgical in tr ume ts

This s c n e itio can els a nd replac s t he first e itio (ISO 7151 : 19 3, of w hic it

c n titute a min r r evisio

0

International O ankation for Stan ar dk ation, 198

Sur gical instr uments -

This Internatio al Stan ar d spe ifie g n r al r eq ireme ts a nd

c r r espo din te t meth d f or a g n r al ran e of n n-c tin ,

T he folow in Stan ar ds c ntain prov isio s w hic , t hrou h

r ef er en e in this te t, c n titute prov isio s of this Inter natio al

wer e v ald Al Stan ar ds ar e s bje t to rev isio , a nd Parie to

agr eeme ts bs d o this Inter natio al Stan ard ar e e c ur -

age to inv estigate t he po sibi ty of aplyin t he mo t r ec nt

e itio s of t he Stan ar ds lste below Members of IEC a nd ISO

maintain re isters of c rr ently vald Inter natio al Stan ar ds

ISO 6 3-13 : 19 6, Heat reat ed ste ls, alo ste ls a nd f ree c t

tin ste ls - Pa 73 : W r ou h t stainle s s te ls

ISO 6 07- 1

Vick ers te t

D - E - F - G -

H - K )

ISO 715 -1 : 19 3, In tr ume ts f or s rg ry - Metalcmaterials

- Par 7 : Stainle s ste l

T he in tr ume ts, e c pt f or in er ts, s al be mad of h gr a de

of stainle s ste l spe ifie in ISO 715 -1 in acor dan e w ith

ta le 1

4.1 Hea t tr eatme t

T he c mpo e t Pars of t he in tume ts s al be h at r eate

u d r s ita le c n itio s t o e s re c mplan e w ith t he re-

q ireme ts of 4.1.2 a nd 4.1.3 f or t he material u e

4.1.2 Har dn s of in tr ume ts

w ithin th r a ng 40 H C t o 48 H C (a pro imately e uiv ale t

t o a Vick ers har dn s ran e of 3 0 H t o 48 H ) w he te te

in acor dan e w ith ISO 6 0 a nd ISO 6 07-1 re pe tiv ely

and s an s, s al n t v ary in har dn s by more t ha n 4 u its o

T he Vick ers har dn s of h tu g te car bid in ers s al be at

least 1 0 0 H 10 whe te te in ac or dan e w ith ISO 6 07-1

T he in ers of op o ite blad s s al n t vary in har dn s by

T able 1

- Ste l gr ad s

Intr u ent an

compnent Pa r ts

Stel gr ade - Refer ene

leter in ac cor da nc e

with ISO 715

-I

Non-ctin , aic lated intr u ents,

exc ept r etr a ctor s

B

Retr a ctor s

A an B

4.2.1 Ge er al

T he in tume t s al c mply w ith o e or both of t he re-

q ireme ts giv en in 4.2.2 a nd 4.2.3

NOT - Two test method ar e sp cified for determinin cor r osion

r esista nce When placin an O e it is inten ed that the pur c ha ser

state whether bth t ests a r e to b car r ied out o if not whic of the

t ests is to b car r ied out I the pur c ha ser dos not so in icate, the

4.2.2 Te t f or r esistan e to toper s lf ate

NOT S

1 The Satin finis s ould b a chiev ed u in an apror iate pr oced r e,

f or example grin in , bru hin , electr oplsin an , in ad ition, Satin

finisin (gla ss badin or Satin br us in ) The finis s ould b

u iform an smoth, an it sould r ed ce glar e

2 In tr u ents of mir r or finis sould b adeq ately gr ou d to r emov e

al s r fc e impr fction an pls ed to r emov e grin in ma r ks in

O er to ac ieve a mir r or finis This s ould b ac ieved u in an a p-

pr opriate pr oced r e, for example plsin , br us in , electrools in

an mir r or bufin

Exept as spe ifie below , th re s al be n platin of toper

platin a t t he e g s of th dr ops of th toper s lf ate Solutio ,

or a t s ld r ed or br az d ju ctio s, or d ln of pols e s r

f ac s cau e by t he top er s lf ate Solutio , s al be disre-

ga r de A slg t platin of top er in smal ar eas of t he joints,

r atc ets a nd s rr atio s of t he jaw s al be disr egar de

4.2.3 Te t f or r esistan e t o boin w ater

Pas iv atio a nd f inal treatme t

of c r ro io

as spe if ie in 5.2, th re s al

be n visible sig s

T he in tume ts s al u le s t he metalurgical c aracteristic

of th in tr ume t (or e ample t he pres n e of br az d or

s ld r ed joints) r en er s it ina pr opr iate, be treat ed by a

p s iv atio pr oc s in ac or dan e w ith g o practic f or th s

type of stainle s ste l

T he in tume ts s al

be man f actur ed

r ec g iz d Stan ar ds of w orkman hip

in ac or dan e w ith th

NOT S

1 Examples of-method of psiva tion ar e by electrools in or by

tretin with 10 % ( V/ V) nitr i acid Solution for not les than 3 min at

a temprature of not les than 10 OC an not exedin 6 OC The in-

str u ents s ould then b r i sed in wa ter an dried in hot air

2 I the joints ar e lubr iated, the lubr i ant s ould b non-cor r osiv e

an sitale for medical aplcation in a c r dan e with the r elev ant na-

tional phar macooia

me h

Ser ratio s s al

in tume t

e actly in t he fuly clo e Po itio of t he

e actly a nd th r e s al be n re istan e whe th in tr ume t is

r eope e

4.5 Elasticity

Shar p e g s a r ou d t he sid s of th jaw s s al be r emov ed

T he elasticity of t he in tume ts s al be te te in acor dan e

w ith 5.3

A fter t he te t, n distor tio ,

mo ificatio s s hal be visible

Cracks or an ot her perman nt

w hic s al be n ith r to lo s n r t oo tig t; it s al be po s-

ible t o clo e a nd reope th in tr ume t easiy w ith two fin er s

T he f un tio of n e le h ld r s s al be te te in ac or dan e

w ith 5.4

4.4.1 Ge eral

T he fibre s al

n t Slp o t, ire pe tiv e of

of th load is lo gitu inal or tr an v er se

w heth r th dir ec tio

Al s t ac s s al be f r ee fom por es, cre ic s a nd grin in

marks T he in tr ume ts s al be s p le f r ee fom r esid al

sale, acid, gr eas , a nd g n in a nd pols in materials Com-

plan e w ith th s r eq ir eme ts s al be c e ked by in pe tio

u in n rmal Visio , c r re te , if n c sary

5.1.1 T est Solutio

T he s rf ac

folow in :

CoperI) s lf ate pe tah drate (CuS04.5H2 )

49

Sulfuric acid [e(H2S04) = 1,84 g/ ml

lo

a) miror pols e ;

Disti e or d -io iz d w ater

b) r efle tio -r ed cin , f or e ample Satin finis , mat blac

finis ;

5.1.2 A pp r atu

Cl

Pu

a n aP

r po e

tac

c atin , f or e ample

for in ulatio

Glas or c ramic beaker

5.1.3 Pr ep r atio of Sample

th r ou hly in distie w ater , dip in 9 % (V/ V) ethan l a nd

dr y

5.2.4 Pr oc d r e

Im ers th in tr ume t in boin w ater (5.2.1) in th beak r or

v sel for at least 3 min Subs q e tly, alow t he in tr ume t

to c ol for a t least 1 h in t he w ater u e f or t he te t

5.1.4 Pr oc d r e

T he r emov e t he in tr ume t fom t he w a ter a nd leav e it e -

po e to th air f or 2 h Rub t he in tume t v ig ro sly w ith a

dry cloth a nd e amin it f or t he pr es n e of blemis e

beak r at r oom temper ature for 6 min Remov e t he in tume t

a nd w as it w ith distie w ater or w ater of e uiv ale t q alty,

or w ipe it w ith w et c to w ool Examin t he in tr ume t f or

ev id nte of t op er d po its

Plac a te t w ire in acor dan e w ith tale 2 or 3 as a pr opr iate

b etwee t he tips of th in tume t jaw s Fuly clo e th in tu-

me t t o th last r atc et Po itio Lea v e t he in tume t in this

Po itio f or 3 h a t r oom temper atur e Examin t he in tr ume t

f or t he pr es n e of Cracks a nd per ma ne t d f or matio

Distie or d -io iz d w ater

5.2.2 A pp r atu

Plac a plastic f ibr e (e.g a s tur e fiame t of maximum

diameter 0,2 m bet w ee th jaw s of h in tr ume t a t a Point

w ithin t he thir d of t he le gth n ar est th tip Fuly clo e t he in-

stume t a nd a ply a te sie f orte of 2 N t o t he f ibr e Re or d

w heth r th f ibr e is pule o t fom t he jaw s

Glas or c ramic beak r or s ita le c rr osio -e istant stainle s

s te l v esel

6.1 T he in tume ts s al be mar ked w ith at least th tr ad -

mark of t he man f actur er or t he s p ler

th r ou hly in w ater (5.2.1) a nd dry

T able 2 - T est w ire for haemo tatic f or ceps

Dimenion in mi metres

T st wir e

I Diameter of

Nominal len th (ov er al len th)

l

Wire of stainles stel

gr ade 1 in a ccor da nc e

with ISO 63-3 or

other simiar mater ial

up to 13

ov er 13 to 15

ov er 15 to 20

ov er 20

T able 3 -

Te t wir e f or n e le h ld rs

Dimenion in mi metres

T est wire

Diameter of

Nominal len th (Ov e l len th)

test wir e

of nedle holder s

Wire of sta inles stel

gr ade 1 in ac cor da n

with ISO 63-3 or

other simiar material

W

up to 16

1

ov er 16

UDC 615.4 2

Des pt o : medical eq ipment s r gical eq ipment r etr a ct o (sr gic al in tr u ents) tests, spcification