Tiêu Chuẩn Iso 05832-1-2016.Pdf

© ISO 2016 Implants for surgery — Metallic materials — Part 1 Wrought stainless steel Implants chirurgicaux — Produits à base de métaux — Partie 1 Acier inoxydable corroyé INTERNATIONAL STANDARD ISO 5[.]

Implants for sur g ery — Metal ic

Part 1:

Impla t chirurgica x — Produits à b se de méta x —

Partie 1: Acier ino yda le cor o é

Fifth edition

2 16-07-1

Refer ence n mb r

ISO 5 3 -1:2 16(E)

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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F r eword i v

Introduction v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms an definitions 1

4 Chemical c omposition 2

4.1 Tes samples 2

4.2 Cas analysis 2

5 Micr ostructure in the full y anne led c on itio 2

5.1 Grain siz 2

5.2 Micr os ructur e 2

5.3 Inclusion content 3

6 Mechanical properties 3

6.1 Tes pie es 3

6.2 Tensie tes 3

6.3 Gaug e leng th 3

7 Test metho s 3

Biblog raphy 6

ISO (he Int ernational Org nization for Stan ardization) is a worldwide fede ation of national s an ards

b dies (ISO membe b dies) The work of pr paring Int ernational Stan ards is normal y car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take p rt in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detai s of

any p t ent right identif ied d ring the develo ment of the document wi be in the Introduction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

For an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lated to conformity as es ment,

as wel as information a out ISO’s adhe enc to the Wor ld Trade Org nization (WTO) principles in the

Te h ical Bar ie s to Trade (TBT) se the folowing URL: www.iso.org iso/for word.html

The committ ee r sp nsible for this document is ISO/TC 1 0, Impla ts fr s urger y, Subcommitt ee SC 1,

Mate ial s

This fifh edition canc ls an r plac s the fourth edition (ISO 58 2-1:2 0 ), w hich has be n t ech icaly

r vised It also incorp rat es the Te h ical C r ig en um ISO 5 3 -1:2 0 / Cor 1:2 0

ISO 58 2consis sof the folowing part , u de the g ene al title Impla t fr s urger y — Metal c mate ials:

— Part 1: Wro g t s tainles s s te l

— Part 2 : Un lo ed tita ium

— Part 3 : Wro g t tita ium 6-aluminium 4-v n diumalo

— Part 4 : Co alt-chromium-mol ybden mc as tin alo

— Part 5: Wro g t c ob lt-chromium-tu gs ten-nickel alo

— Part 6 : Wro g t c ob lt-nickelchromium-molybden m alo

— Part 7: Forgea le a d c old-frmed c ob lt-chromium-nickelmolybden m-ro alo

— Part 8: Wro g t c ob lt-nickelchromium-molybden m-tu gs ten-ro alo

— Part 9: Wro g t hig nitro en s tainles s s te l

— Part 1 : Wro g t tita ium 6-aluminium 7-nio ium alo

— Part 12 : Wro g t c ob lt-chromium-molybden m alo

— Part 14 : Wro g t tita ium15-molybden m5-z irc onium 3-aluminiumalo

No k own surgical implant mat erial has eve be n shown t o be complet ely fr e of adve se r actions in

the h man b dy Howeve , long -t erm clnical ex e ienc of the use of the mat erial r fe r d t o in this

p rt of ISO 5 3 has shown that an ac epta le level of biolo ical r sp nse can be ex e t ed w hen the

mat erial is used in a pro riat e a pl cations

The folowing def initions a ply in u de s an ing how t o implement an ISO Int ernational Stan ard an

othe normative ISO delve a les (TS, PAS, IWA):

— “ hal” in icat esa r q ir men

— “ hould” indicat es a r commen ation;

— “ ma ”is used t o in icat e that something is pe mitt ed;

— “can” is used t o in icat e that something is p s ible, for ex mple, that an org nization or in ivid al

is a le t o do something

3.3.1 of the ISO/IEC Dir ctives, Part 2 ( ixth edition, 2 1 ) defines a r q ir ment as an “ex r s ion in

the cont ent of a document conveying c it eria t o be fulf iled if complanc with the document is t o be

claimed an from w hich no deviation is pe mitt ed.”

3.3.2 of the ISO/IECDir ctives, Part 2( ixth edition, 2 1 ) def ines a r commen ation asan “ex r s ion

in the cont ent of a document conveying that among seve al p s ibi ties one is r commen ed as

p rticularly suita le, without mentioning or ex clu ing othe s, or that a c rtain course of action is

pr fe r d but not ne es ariy r q ir d, or that ( in the neg tive form) a c rtain p s ibi ty or course of

action is depr cat ed but not prohibit ed.”

Implants for sur g ery — Metal ic materials —

Part 1:

This p rt of ISO 5 3 spe if ies the charact eris ics of, an cor esp n ing t es methods for, wrought

s ainles st eel for use in theman factur of surgical implant

NOTE 1 T e mechanical properties of a sample o tained from a f inished prod ct made of this aloy can difer

from those specif ied in this part of ISO 5 3

NOTE 2 T e al oy des rib d in this part of ISO 5 3 cor espon s t o UNS S 16 3 refer ed t o in

ASTM F1 8 ASTM F1 9an t o aloy code 1.4 41 given in the with rawn DIN 17443

2 Normati ve referenc es

The folowing document , in w hole or in p rt, ar normatively r fe enc d in this document an ar

in ispensa le for it a pl cation F or dat ed r fe enc s, only the edition cit ed a ples F or un at ed

r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment )a ples

ISO 3 7, Stee l a d s te e l produc ts — L catio a d pre paratio o samples a d tes t pie es fr me ch nical testin

ISO 404, Ste l a d s te l produc ts — G ene al te h ic al deli ver y r q ir ment

ISO 43 , Ste l a d iro — Dete min tio o total s ilc on c ontent — Grav imetric meth d

ISO 6 9, Ste l a d c as t iro — Dete min tio o ma g nese c ontent — S ec tro h tometric meth d

ISO 643, Ste ls — Mic ro ra hic dete min tio o the a p r nt grain s i ze

ISO 6 1, Ste l a d c as t iro — Dete min tio o s ulp ur c ontent — Comb s tio titrimetric meth d

ISO 49 7 :2 1 , Ste l — Dete min tio o c ontent o n n-metal c inclus io s — Mic ro ra hic meth d us in

s ta dard dia rams

ISO 68 2-1:2 1 , Metal c mate ials — Tens ile tes tin — Part 1: Meth d o tes t at ro mtempe atur

ISO 1 7 4, Ste l a d iro — Dete min tio o p os ph rus c ontent — Ph s ph v n domolybdate

s pec tro h tometric meth d

3 Terms and definitions

F or the purposes of this document, the fol owing t erms and def initionsa ply

3.1

original g ug e length

length betwe n g ug e length marks on the t es pie e measur d at ro m t empe atur befor the t es

[ SOURCE:ISO 6 9 -1:2 1 , 3.1.1]

4 Chemical c omposition

4.1 Test samples

The sele tion of samples for analy sis shal be car ied out in ac ordanc with ISO 3 7

4.2 Cast anal ysis

The cas analy sis of the st eel w hen det ermined in ac ordanc with Cla use 6 shal comply with the

chemical comp sition spe ified in Ta le 1 The moly bden m and chromium cont ent shal be such that

the C v lue o tained from F ormula (1) is not les than 2

C = 3,3w

Mo

+ w

Cr

(1)

w he e

w

Mo

is the moly bden m cont ent, ex r s ed as a pe c ntag e b mas ;

w

Cr

is the chromium cont ent, ex r s ed as a pe c ntag e b mas

Table 1 — Chemical compositio

%

5 Microstructure in the full y annealed c ondition

5.1 Grain size

The aus enitic grain siz , dete mined in ac ordanc with Clause 6, shal not be co rse than grain

siz No 5

5.2 Micr ostructur e

The st eel shal ha ea s ructur fr e from delta fe rit e, chi or sigma phase, w hen ex mined in ac ordanc

with Clause6

5.3 Inclusion c ontent

The non-metal c inclusion cont ent of the st eel, det ermined at finished siz aft er a hot-rol ing proc s

s ag e an in ac ordanc with Cla use 6, shal not ex ce d the l mit given in Ta le 2

NOTE It can b neces ary t o use vacu m or electrosla melting to prod ce a ste l complying with these

cle nlines req irements

Table 2— Inclusio co tent l mits

Ty e of inclusion

Inclusion cont ent r fe enc n mbe

6 Mechanical properties

6.1 Test piec es

The sele tion and pr p ration of samples an t es pie es for t ensi e t es ing shal be in ac ordanc with

ISO 3 7

6.2 Tensi e test

The t ensie pro e ties of the st eel in the form of b rs, wir s, an she t and s rip, w hen t est ed in

ac ordanc with Cla use 6, shal comply with the v lues spe if ied in Ta les 3, 4 an 5, r spe tively

Should any of the t es pie es not me t the spe if ied r q ir ment or br ak out ide the g ug e lmit ,

r t es s shal be car ied out in ac ordanc with ISO 404

6.3 Gaug e leng th

Original g ug elength l

0 shal be eithe 5,65×

0

S or 5 mm, w he e S

0

is defined as the original c os

-se tional ar a in sq ar mi imetr s The g ug e length chosen for t es ing shal be r p rt ed with the t es

r sult

The t es methods t o be used in det ermining complanc with the r q ir ment of this p rt of ISO 5 3

shal be those given in Ta le 6

Table 3 — Mechanical pro erties of bar

Diamet er or

thick es

Tensie s r ngth

0,2 % pro f s r s

of

non-pro ortional

elong tion

Elong tion aft er

fracture/

g uge length

m

R

p ,2

A

m

m

Table 4 — Mechanical properties of wires

Elong tion aft er

fracture/

g uge length

m

A

min

An e led

Cold drawn

a

0,2 ≤d ≤0,7 1 60 ≤ R

m

0,7 < d ≤ 1 15 0 ≤R

m

1 <d ≤ 1,5 1 40 ≤R

m

1,5< d ≤ 2 13 0≤ R

m

a

Wire ordered in the c ld-drawn c n ition c n be su pled to hig er tensie s ren th levels as spe if ied b the

p rchaser

Table 5 — Mechanical pro erties of strip and she t

Tensi e s r ngth

0,2 % pro fs r s of

non-pro ortional

elong tion

Elong tion aft er

fracture/

g ug e length

m

R

p ,2

A

m

m

Table 6 — Test methods

(ISO methods, where these e ist)

a

specimens in the an e led

con ition from longitu inal

an transver e sections

b) Using reco nized tech iq es,

e amine the specimens at

1 0 ma nif ication for the

presence or a sence of delta

fer it e an carbides

Mechanical properties

— tensile strength

— pro f stres of non-proportional

— elong tion

— elong tion af er fracture

Clause 6

ISO 68 2-1

a

It is prefer ed that amples for grain siz determination be sele ted afer the las an e ln operation an prior to the

final c ld-w orkin operation If samples are sele ted afer a final c ld-w orkin operation, t ansver e spe imens should be

prepared

Bibl og raphy

[1] ASTM F 3 , Sta dard S ec ific atio fr Wro g t-18 Chromium-14 Nickel- 2.5 Molybden m Stainles s

Ste l B ar a d Wir fr S rgic al Impla ts (UNS S 1673)

[2] ASTM F 3 , Sta dard S ec ific atio fr Wro g t-18 Chromium-14 Nickel- 2.5 Molybden m Stainles s

Ste l S e t a d Strip fr S rgic al Impla ts (UNS S 1673)

1)

, R oled a d w ro g t s tainles s s te l produc ts fr s urgic al impla ts; technic al deli ve y

c onditio s

1) Withdr aw n

ICS  11.040.40

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