Tiêu Chuẩn Iso 05832-7-2016.Pdf

© ISO 2016 Implants for surgery — Metallic materials — Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy Implants chirurgicaux — Produits à base de métaux — Partie 7 Alliag[.]

Implants for sur g ery — Metal ic

Part 7:

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

Partie 7: Aliage à frge mis en frme à froid à b se de co alt,de

chrome, de nicke l,de moly dène et de fe

T ir d edition

2 16-1 -1

Reference n mb r

ISO 5 3 -7:2 16(E)

© ISO 2016, P blshed in Sw itz rlan

A ll rig hts r eserved Unles otherw ise spe ified, nopar of this p blc tion ma y be r epr od c d or utilz d otherw ise in an form

or b an me ns, ele tr onic or me hanic l, inclu in p oto opying , or postin on the internet or an intranet , w ithout prior

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

ISO c pyrig ht ofic

C de Blan on et 8 • C 4 1

CH-1 14 Vernier, Geneva, Sw itzerlan

Tel + 12 7 9 011

Fax 412 7 9 0 4

c pyrig ht@iso.or g

www.iso.or g

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

5.1 Grain siz 2

5.2 Inclusion content 2

6 Mechanical properties 2

7 Test metho s 3

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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 third edition canc ls an r plac s the se ond edition (ISO 5 3 -7 :1 94 ), w hich has be n t ech icaly

r vised

A l s of al p rt in theISO 5 3 se ies can be fou d on the ISO websit e

iv

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

document 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 con itions

Implants for sur g ery — Metal ic materials —

Part 7:

This document pe if ies the charact eris ics of, an cor espon ing t es methods for, forg ea le an

cold-formed co alt-chromium-nickel-moly bden m-iron 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 aloy do not

neces arily comply with those specif ied in this document

2 Normati ve r eferences

The folowing document ar r fe r d t o in the t ext in such a wa that some or al of their cont ent

cons itut es r q ir ment of this document 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 643, Ste ls — Mic ro ra hic determin tio o the a p r nt grain s i ze

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

s ta dard dia rams

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

3 Terms and definitions

No t erms an def initions ar lst ed in this document

ISO an IEC maintain t erminolo ical data ases for use in s an ardization at the folowing ad r s es:

— IECEle tro edia: a aia le at ht p:/ www.ele tro edia.org

— ISO Onlne brow sing plat orm:a ai a le at ht p:/ www.iso.org o p

4 Chemical composition

The heat analy sis of the alo w hen det ermined as spe if ied in Clause 7 shal comply with the chemical

comp sition spe if ied in Ta le 1 The analy sis of samples taken from prod ct man factur d from the

alo shal also comply with Ta le 1

Table 1 — Chemical compositio

Element

Element comp sitional l mit ,

% (m/m )

5 Microstructure

5.1 Grain size

The mic osco ic s ructur shal be u iform The grain siz , det ermined as spe if ied in Cla use 7, shal be

no co rse than grain siz No 5

5.2 Inclusion c ontent

The non-metal ic inclusion cont ent of the alo , det ermined as spe if ied in Clause 7, shal not ex ce d the

l mit given in Ta le 2

Table 2— Inclusio co tent l mits

a

A – Sulf ides

B– Aluminates

C – Silicates

D – Oxides, glo ular

1

3

1

3

a

There shal be no thick inclusions

6 Mechanical properties

The me hanical pro e ties, det ermined as spe if ied in Clause 7, shal be in ac ordanc with the

r q ir ment of Ta le 3

2

Table 3— Mechanical pro erties

C n ition

Tensi e s r ngth

min

MPa

Pro f s r s of non-

pro ortional elong tion

min

MPa

Pe c ntag e elong tion

min

%

a

For spe ific ap lc tions

7 Test methods

The t es methods t o be used in det ermining complanc with the r q ir ment of this document shal

be those given in Ta le 4

Table 4 — Test methods

R equir ment

R elev nt clause or

subclause

Tes meth d

C emical composition

Clause 4

Reco nized analyt ical pr oced ures (ISO

methods where these e ist)

Mechanicalproperties

Tensile strength

Per entag e elong tion

Pro f stres of non-proportional elong tion

© ISO 2016 – A ll rig hts r eserved

ICS  11.040.40

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