Tiêu Chuẩn Iso 05832-3-2016.Pdf

© ISO 2016 Implants for surgery — Metallic materials — Part 3 Wrought titanium 6 aluminium 4 vanadium alloy Implants chirurgicaux — Produits à base de métaux — Partie 3 Alliage corroyé à base de titan[.]

Implants for sur g ery — Metal ic

Part 3:

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

Partie 3: Aliage cor o é à b se de tita e, d’aluminium-6 et de

v n dium-4

Fourth edition

2 16-1 -1

Refer ence n mb r

ISO 5 3 -3:2 16(E)

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

the r eq eser

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C de Blan on et 8 • C 4 1

CH-1 14 Vernier, Geneva, Sw itzerlan

Tel + 12 7 9 011

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c pyrig ht@iso.or g

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F reword 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 1

5 Micr ostructure 2

6 Mechanical properties 2

6.1 Tensie

2 6.2 Bending 3

7 Test metho s 3

A nne x A (normative) Catalog ues of metal og r aphic microg raphs of typical alp a+beta titanium micr ostructur es 4

A nne x B (informative)Mechanical Properties Har mo ization betwe n ISO and ASTM w rought titanium 6-aluminium 4-vanadium Implant Mater ial Standar ds 5

Biblog raphy 7

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

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly 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 part 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 Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction 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 fourth edition canc ls an r plac s the third edition (ISO 5 3 -3:1 9 ), w hich has be n t ech icaly

r vised

ISO 5 3 consis sof the fol owing p rt , un e the g ene al title Impla ts fr s urge 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-molybden m c 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-aluminium alo

No k own surgical implant mat erial has eve be n shown t o cause a solut ely no 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

Implants for sur g ery — Metal ic materials —

Part 3:

This p rt of ISO 5 3 spe ifies the charact eris ics of, an cor esp n ing t es methodsfor, the wrought

titanium alo k own as titanium 6-aluminium 4-v nadium alo (Ti 6-AI4- V alo ) for use in the

man factur of surgical implant

NOTE T e mechanical properties of a sample o tained from a f inished prod ct made of this al oy may not

neces arily comply with the specif ications given in this part of ISO 5 3

2 Normati ve r eferences

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 pl es F or u dat ed

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

ISO 68 2-1

1)

, Metal c mate ial s — Tens ile tes tin — Part 1: Meth d o tes t at ro m tempe atur

ISO 743 , Metal c materials — B end tes t

ISO 2 1 0, Impla ts fr s urge y — Metal c mate ials — Clas s ific atio o mic ros truc tur s fr alp a +beta

tita ium alo b rs

EN 3 14-00 , Ae os pac e s eries — Tes t meth d — Mic ros truc tur o (α+ β) tita ium alo w ro g t

produc ts — Part 00 3 : Mic ros truc tur o plate

3 Terms and definitions

F or the purp ses of this document, the t erms an definitions given in ISO 6 9 -1 an the folowing a ply

3.1

original g ug e length

L

o

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:—, 3.1.1]

4 Chemical composition

The heat/ing ot analy sis of a r pr sentative sample of the alo w hen det ermined in ac ordanc with

Clause 6shal comply with the chemical comp sition spe if ied in Ta le 1

NOTE 1 Ing t analysis may b used for determining al chemical req irements ex cept hydro en

The analy sis of hydrog en shal be car ied out aft er the f inal heat tr atment an f inal surfac tr atment

R eq ir ment for the major and minor elemental cons ituent for titanium 6-aluminium 4-v nadium

alo ar l st ed in Ta le 1

1) To b p blished (Revision of ISO 68 2-1:2 0 )

Table 1 — Chemical compositio

% (m/m )

a

a

Ex ept for bi et , for which the ma imum hydrogen

c ntent hal be 0,010 % (m/ m)

NOTE 2 A grade with more restrictive limits of o y gen an iron is k own u der the term “e tra low

inter titials” (E I Commer ialy availa le E I mat erial can also b ordered using this part of ISO 5 3 F or e act

compositional limits of the E I grade refer t o ASTM F1 6 (UNS R54 0 ) (www.astm.org)

5 Microstructure

The mic os ructur , w hen ex mined as indicat ed in Ta le 3, shal be alpha + beta glo ular an shal

cor esp n t o phot omic o ra hs A1 t o A9 in ISO 2 1 0 for rou d b rs or 3T1 t o 3T1 in EN 3 14-0 3

for she t an plat es (annealed con ition each)

6 Mechanical properties

6.1 Tensi e

The t ensie pro e ties of the alo , w hen t est ed in ac ordanc with Clause 7, shal comply with the

v lues spe ified in Ta le 2

Table 2— Mechanical pro erties of wrought titanium 6-aluminium 4-vanadium alo in

anne led co dition

F orm of alo Tensi e s r ngth Pro fs r s of

nonpro ortional

elong tion

Pe c nta e

elong tion aft er

fractur

a

Man r l

diamet er for

ben t es

R

m

R

p ,2

She t an strip

c

Bar

c

a

Original gau e len th L

0

eq al to (5,65 × √S

0 ) or 50 mm, where S

0

is the original cros -se tional are in sq are

mi imet es The original gau e len th chosen for tes in shal be repor ed with the tes result

b

t is the thick es of the she t or s rip

c

Ma imum diameter or thick es is eq al to 75mm

NOTE For information on the Mechanical Properties Harmonization b tween ISO an ASTM wrought

titanium 6-aluminium 4-vanadium Implant Material Stan ards, se An e B

Should any of the t es pie es not me t the spe ified r q ir ment , or should they br ak out ide the g ug e

l mit , two furthe t es pie es r pr sentative of the same b t ch shal be t est ed in the same man e The

alo shal be de med t o comply only if b th ad itional t es pie es me t the spe ified r q ir ment

Howeve , the man factur r ma r -heat-tr at the mat erial and r submit it for t es ing in ac ordanc

with this p rt of ISO 5 3 In this case, al p rt shal be heat-tr at ed in the same fashion

Titanium alo she t an s rip, w hen t est ed in ac ordanc with Clause 7, shal not how any c acking on

the out ide surfac of the t es pie e

7 Test methods

The t es methods used in det ermining compl anc with this p rt of ISO 58 2 shal be those given in

Ta le 3

R epr sentative t es pie es for the det ermination of me hanical pro e ties shal be pr p r d in

ac ordanc with the pro isions of ISO 68 2-1

Table 3 — Test methods

(ISO methods where these e ist)

Mic ostructure

Bar

She t an strip

5

ISO 2 160

EN 3 14– 0

Pro f stres of non roportional

elong tion

ISO 68 2-1

Ben the she t or strip through an angle

of 1 5° arou d a man rel of the diameter

specif ied in Ta le 2

A nnex A

(normative)

In this an ex, two dife ent s an ards ar r fe enc d showing mic os ructur s of ty ical alpha +beta

titanium al o Ti 6Al 4V int ended for the use of identif ication an clas if ication of the mic os ructur

of a given mat erial ISO 2 1 0 is pr senting mic os ructur s in the transve se se tion at × 0

ma nif ication ISO 2 1 0 a ples t o rou d b rs up t o a nominal diamet er of 1 0 mm It was r placing

ETTC 2 E ition 2

Mic os ructur s of flat roled prod ct , lke she t or plat es, can ot be rat ed ac ording t o ETTC 2

F or this ty e of prod ct, anothe mic os ructural catalo ue was made a ai a le ETTC 4 Edition 2

is showing mic os ructur s in the transve se se tion at × 0 an × 0 ma nif ication Prod ct siz s

of this catalo ue we e lmit ed t o a rang e of thicknes es a o e 5 mm an below 3 mm The same

mic os ructur s ar shown in EN 3 14-0 3 but with dife ent designations Ta le A.1 show s the

cor elation of the designations of the mic o ra hs betwe n E TC 4 Edition 2 an EN3 14-0 3

ETTC4 Edition 2 is showing ac epta le mic os ructur s in the rang eof P1 t o P3 for Stan ard A erosp c

Q ualty ( STQ) F r medical a plcation, the rang e of ac epta le mic os ructur s is int entionaly l mit ed

t o P1 (3T1) t o P1 (3T1 )at × 0 ma nification showing glo ular s ructur s

ETTC 4 Edition 2 is conside ing only plat es, i.e prod ct o e or eq al 5 mm in thick es It is

r commen ed he e t o usethe mic os ructural pictur s also for siz s eq al t o or below 5 mm

Table A.1 — Cor elatio betwe n designations of mic ographs ETTC 4 Edition 2 ver us

EN 31 4–003

A nne x B

Standards

It isr co niz d that mat erial sup le s might int en t o sel their prod ct aroun the world The efor ,

this an ex is int en ed t o pro ide me hanical pro e ty information for those prod ct w hich might

be r q ir d t o conform t o the r lev nt wrought titanium 6-aluminium 4-v nadium Implant Mat erial

Stan ards from b th ISO an ASTM

Table B.1 — Mechanical Pro erties Harmo ization for ELI grade

(ISO 5 32-3 and ASTM F136–13)

ISO + ASTM

spe ification

Mat erial

sha e

Ben t es man r l

diamet er

ISO 5 3 -3

+

ASTM F1 6– 3

Bar

63,5 ≤ d ≤ 75

a

She t an

strip

4,75 ≤ t < 4,7 6 ≥ 60 ≥79 ≥ 0 ≥ 5 1 × t

4,7 6 ≤ t < 4 ,45 ≥ 60 ≥79 ≥ 0 ≥ 5 —

63,5 ≤t < 75

a

a

Material diameter or thick es lmit defined in this par of ISO 583

NOTE Portions of this ta le have b en e tract ed from ASTM F1 6– 3, cop right ASTM International, 1 0

Bar Harb r Drive, West Conshohock en PA 1 42 A cop of the complete stan ard can b o tained from ASTM

(www.astm.org)

Table B.2— Mechanical Pro erties Harmo ization for no -E I grade

(ISO 583 -3 and ASTM F 4 2 1 )

ISO + ASTM

spe ification

Mat erial

sh pe

Ben t es mandr l

diamet er

ISO 5 3 -3

+

ASTMF1472 14

Bar

5 ≤ d ≤ 75

a

She t an

Strip

1,6 ≤ t < 4,7 6 ≥ 24 ≥ 69 ≥ 0 — 1 ×t

4,7 6 ≤ t < 75

a

a

Material diameter or thick es lmit def ined in this par of ISO 583

NOTE Portions of this ta le have b en e tract ed from ASTM F1472 14, cop right ASTM International, 1 0

Bar Harb r Drive, West Conshohocken PA 1 42 A cop of the complet e stan ard can b o tained from ASTM

(www.astm.org)

Bibl og raphy

[1] ASTM F 3 -1 , Sta dard S ec ific atio fr Wro g t Tita ium-6 Alumin m-4 Va adium ELI (Ex tra

L w Inte s titial Alo fr S rgic al Impla t Ap lc atio s (UNS R564 01)

[2] ASTM F 47 -14, Sta dard S ec ific atio fr Wro g t Tita ium-6 Alumin m-4 Va adium Alo fr

S rgic al Impla t Ap lc atio s (UNS R56 0 )

[3] Publcation ETTC 2 Edition 2, Mic os ructural s an ards for alpha +beta titanium alo b rs,

pr par d b the Te h ical C mmitt ee of E ro ean Titanium prod c rs, 1 9 (out of print)

[4 ] Publcation ETTC 4, Edition 2, Mic os ructural s an ards for alpha +beta titanium al o b rs,

pr par d b the Te h ical C mmitt ee of E ro ean Titanium prod c rs, 1 9 (out of print)

ICS  11.040.40

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