Tiêu chuẩn iso tr 18130 2016

© ISO 2016 Dentistry — Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants Medecine bucco dentaire — Essai de dévissage d’une[.]

Dentistr y — Screw loosening test

using cyclic torsional loading for

implants

Medecine b c o-dentaire — Essai de dé issage d’u e vis utilisant u e

ch rge de torsion c yclique p ur le corps d’impla t/pilier impla taire

des impla t dentaires endo-osseu

Refer ence n mb r Fir t edition

2 16-0 -0

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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F reword i v

Introduction v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms and definitions 1

4 General pr inciple 2

5 Test metho s 2

5.1 Tes con ition 2

5.2 Torque mete 2

5.3 Pr eparation of tes spe imens 2

5.4 Initial scr ew r emo al tor que 3

5.4.1 Pr oc d re 3

5.5 S r ew r emo al tor que afe cyclc tor que tes 3

5.5.1 C clc tor que tes e 3

5.5.2 Torque tr ansd c r 4

5.5.3 Pr oc d re 4

5.6 Ev luation 5

6 Test rep rt 5

Biblog raphy 6

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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 ofISO spe ific terms an ex r s ions r lat ed 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 6, Denti s try, Subcommitt ee SC 8, Dental

impla ts

Mos en os eous dental implant cur ently market ed emplo a dental implant b dy that is inse t ed

within the jaw b ne an t o w hich othe comp nent ma be joined w hen cons ructing a pros hetic

supe s ructur The con e tion betwe n these component an the implant b dy should be sufficiently

rigid t o r sis ve tical mas icat ory lo ds, w hich ha e a signif icant t orsional comp nent E dos eous

dental implant ma , the efor , incorp rat e featur s t o r s rict rotation at the con e tion If this is

insufficiently s rong, then u desira le incident , inclu ing sc ew lo sening, dist ortion an fractur of

the l nked comp nent wi l oc ur A cyclc t orsional sc ew lo sening t es for the conne tion between

implant b dy and implant a utment would faci tat e comparative ev luation

Dentistry — Screw loosening test using cyclic torsional

This Te h ical R eport pro ides guidelnesfor a method t o det ermine the ext ent of sc ew lo sening of the

metal c implant b dy implant a utment joint of en os eous dental implant , such astwo-p rt implant

or multi-p rt implant un e cyclc t orsional lo ding This t es is mos a pro riat e for ev luating new

ty es of joint f ix ed using sc ew (s) an metal ic conne ting p rt This Te hnical R ep rt pro ides a

prot ocol for t orsional cycl c t orq e on an implant b dy implant a utment joint, but it int en ed use is

for pr fa ricat ed implant b dies, implant a utment an , if a pro riat e, implant con e ting part that

ar made of metal c mat erials

It is not a plca le t o ensur the in v i vo pe formanc of en os eous dental implant an is not de ived

from o se v tions of clnical faiur s

NOTE T is Tech ical R eport is not inten ed for use with t emporary a utments

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 1 42, Denti s tr y –Voc ab lary

ISO 1 443, Denti s try – Voc ab lary fr dental impla ts sys tems a d r lated proc edur

3 Terms and definitions

F or the purp ses of this document, the t erms an definitions given in ISO 1 42 an ISO 1 443 an the

folowing a ply

3.1

cyclc torque

r peat ed t orsional for e alt ernatively clockwiseand count er clockwise

3.2

s rew loosening

de r ase in sc ew r mo al t orq e r lative t o the r mo al t orq e w hen the a utment sc ew was firs

ins al ed

3.3

s rew tightening torq e

t orq e v lue for sc ew r q ir d t o tight en the implant a utment, an the implant con e ting p rt if

a pro riat e, t o the implant b dy as pe spe if ied b the man factur r

3.4

s rew removal torq e

t orq e v lue for sc ew r q ir d t o de ons ruct the conne tion betwe n the implant b dy an the

implant a utment, an the implant con e ting p rt if a pro riat e

temporary abutment

implant a utment or t emp rary usag e

4 General principle

The en uranc pro e ties of implant b dy implant a utment int erfac should be t est ed b a plying a

cyclc alt ernating t orsional lo d t o the implant b dy an implant a utment clamped in the t es ing devic

Tes ing should be pe formed on finished devic s or spe imens that ha e an implant a utment joint

eq iv lent t o the finished devic ( i.e component that ha e un e g one the same man facturing

proc s as the devic that is t o be market ed) If the man factur r int en s the implant comp nent t o be

st eri z d b the clnician prior t o surg ery, st eri zation should be car ied out befor t es ing as spe if ied

in the man factur r’s ins ructions for use However, if the e is evidenc that the spe ified st eri ization

method has no significant efe t on the pro e ties of al the mat erials of the spe imens being t est ed,

st eri zation is not ne es ary prior t o t es ing If so, this should be document ed in the t es r p rt

If a dental implant sy st em t o be t est ed consis s of seve al ty es of implant a utment with the same

conne ting int erfac , a s raight implant a utment ha ing a metal c conne ting int erfac should be

sele t ed for t es ing

NOTE Angulat ed implant a utments can ot b test ed b cause the central a is of con ected test specimens

is not straight

5.1 Test c ondition

Car y out the t es at (2 ± 1 ) °C

5.2 Tor que meter

Use a t orq e met er with an ac uracy of 0,3 N∙cm or les

NOTE An e ample of a torq e meter is HDP-5

1)

man factured by HIOS INC, Japan

5.3 Preparation of test specimens

The implant a utment, an implant con e ting p rt if a pro riat e, should be f ix ed on the implant b dy

using the spe ified/r commen ed sc ew at sc ew tight ening t orq es s at ed b the man factur r’s

ins ructions for use The sc ew tight ening t orq e should be a pled using a t orq e met er The en s of

the t es spe imens ma be modif ied int o sha es larg er than the ma imum diamet er of implant b dy

an / r implant a utment t o mor easiy clamp with the holde s An ex mple ofa t es spe imen is

i lus rat ed in Figur 1

NOTE A t le st six specimens for e ch t est ac ording to 5.4 an 5.5 are req ired t o compare the me n of the

s rew removal t orq es afer cyclic torq e test with the me n of the initial s rew removal torq es

1) HDP -5 is an example of a suita le pr od ct a vaila le commer cialy T is information is g iven for the con venience

of user of this document an do s not constitute an en or ement by ISO of this pr od ct

1 implant b d

2 implant a utment

3 a utment s r ew

Figure 1 — Schematic of a test specimen

5.4 Initial s rew removal torque

5.4.1 Pr oc edure

The initial sc ew r mo al t orq e of six spe imens should be measur d ac ording t o the folowing

proc d r

a) The implant a utment, an implant con e ting part, if a pro riat e, should be fix ed on the

implant b dy using the spe if ied sc ew at sc ew tight ening t orq es s at ed in the man factur r’ s

ins ructions for use These implant comp nent should be new ones that ha e neve pr viously

be n as embled

b) Aft er 5 min, measur the sc ew r mo al t orq e b t orq e met er

c) Calculat e the mean and s an ard deviation of initial sc ew r mo al t orq e from the o tained

v lues for the at leas six spe imens

5.5 Screw removal torque afer cycl c torque test

5.5.1 C clc torque tester

The t es devic should have the folowing p rt :

― spe imen holde s (he implant b dy an implant a utment should each be held at a ma imum of

5mm from the joint lne betwe n them);

― t orq e transd c r;

― t orsional cyclc driving devic that can a ply cyclc t orq e gr at er than 1 % of sc ew tight ening

t orq e;

― t orsional cyclc displac ment ransd c r

An ex mple of a t orsional t es ing devic is i us rat ed in Figur 2

The c ntral long ax esof the shaf s of the t orq etransd c r an t orsional driving devic should coincide

1 specimen holder

2 tor que tr ansd cer

3 tor ional cyclic driving device

4 tor ional cyclic displacement transd cer

5 lever arm

6 output of tor ional displacement to recor der

7 output of tor ional tor que to r ecor der

8 implant b d

9 implant a utment

Figure 2— Example of testing device for cycl c torque test

5.5.2 Tor que transduc er

The ac uracy of the t orq e transd c r eq ip ed in the cycl c t orq e t est er ( e 5.5.1) should be les

than ± 1 % of the ma imum t orq e t o be t est ed

5.5.3 Proc edure

a) The implant a utment, an implant conne ting p rt, if a pro riat e, should be f ix ed on the implant

body using the spe if ied sc ew at sc ew tight ening t orq es as s at ed in the man factur r’ s

ins ructions for use These implant comp nent should be new ones that ha e neve pr viously

be n as embled

b) Aft er 5 min, clamp the r taining p rtions of the implant b dy an implant a utment of a t es

spe imen int o the spe imen holde s of the t es ing devic The implant b dy an implant a utment

should each be held at a ma imum of 5 mm from the joint l ne betwe n them

c) Ap ly cyclc t orq e (clockwise an cou t er clockwise) up t o 1 % of the sc ew tight ening t orq e

s at ed in the man factur ’s ins ruction t o the implant a utment with the velocity of 1 degr e pe

min t e R epeat this cyclc t orq e up t o 1 00 0 cycles

d) When the spe imen survives without deformation an / r fractur aft er 1 0 0 0 cycles, measur

thesc ew r mo al t orq e b t orq e met er When the spe imen does not urvive, r cord the n mbe

of cycles w hich it survives

e) Aft er the t es , o se ve the wear an deformation of the implant b dy conne ting joint b a

mic osco e

f) A t leas six spe imensshould bet est ed

g) Calculat e the mean an s an ard deviation of the measur d sc ew r mo al t orq e aft er cyclc

t orq e t es of at leas six spe imens

NOTE 1 Implant b d an implant a utment joint part are se led by s rew tightening an the part may not b

afected by cor osion d ring 1 0 0 0 times cyclic torq e test e.g 1 d or 2 d)

NOTE 2 An e ample of the t esting machine is AG-XR

2)

man factured by Shimadzu Corporation, Japan

5.6 Evaluation

Calculate the ratio of the mean initial sc ew r mov al torq e to the sc ew tight ening torq e C lculate the

ratio of the mean sc ew r mov al torq e aft er cyclc t orq e t es t o the mean initial sc ew r mov al torq e

6 Test r eport

The t es r p rt hould inclu e at leas the folowing information:

a) a r fe enc t o this Te h ical R ep rt, i.e ISO/TR 1 1 0;

b) the identification of the emplo ed t es spe imens, inclu ing the ty e of con e tion ( int ernal

anti-rotation: ta er-f it, not ch-fit, hex g onal, et c ext ernal anti-rotation: hex g onal, et c ),

man factur r( ), p rt n mbe s and lot n mbe s of the t est ed p rt , mat erial( ) ofthe t est ed p rt ,

diamet er an length of the implant b dy an implant a utmen

c) if a plca le, the document ed evidenc that the spe if ied st eri zation method has no signif icant

efe t on the pro e ties of al mat erials;

d) thet es method inclu ing the t es con ition, t es ing devic , sc ew tight ening t orq e a pl ed t o the

sc ew s, cyclc t orq e, n mbe of cycles, dis anc from the int erfac at w hich the comp nent we e

held an a drawing of the emplo ed t es spe imens;

e) ther sult o tained, namely

1) the initial sc ew r mo al t orq e an the ratio t o the sc ew tight ening t orq e,

2) the sc ew r mo al t orq e if the spe imen survived 1 0 00 cycles and the ratio t o the initial

sc ew r mo al t orq e,

3) if the spe imen does not survive, the n mbe ofcycles w hich the t es ing spe imen survives,

4 ) the mic osco ic o se v tion on deformed an / r fractur d p rt of t es spe imens

Bibl og raphy

[1] ISO 8 8-7, Mecha ic al pro erties o f s tene s — Part 7: Tors io al tes t a d minimum torq es fr

b lts a d sc rews w ith n min l diamete s 1 mm to 10 mm

[2] ISO/TS 1 49 , Denti s tr y — Tors io tes t o impla t b dy/c on ec tin p rt joint o endos s eo s

dental impla t sys tems

[3] ASTM F 43-0 , Sta dard s pec ific atio a d tes t meth ds fr metal c medic al b ne s c rews

[4 ] Anders on B Odman P Ca l son L Brånema k P.I A new Brånemark single t ooth

a utmen han l ng an early clnical ex e ienc s In J Oral Max iloac Impla ts 1 9 , 7 (1)

p 1 5 1 1

[5] Bal our A & O’Brien G.R Comp rative s u y of antirotational single t ooth a utment J

Pros thet Den 1 9 , 73 (1) p 3 –43

[6] Car oso M T or es M.F Lourenço E.J De Moraes Tel es D R od igues R.C Rib ir o

R.F Torq e r mo al ev luation of pros hetic sc ew s aft er tight ening an lo sening cycles:an in

vitro s u y Cln Oral Impla ts R es 2 1 , 23 p 47 –48

[7] Guzaitis K.L Kno r s hild K.L Viana M.A Efe t of r peat ed sc ew joint closing an

o ening cycles on implant pros hetic sc ew r ve se t orq e an implant an sc ew thr ad

morpholo y J Pros thet Den 2 1 , 1 6 (3) p 1 9– 6

[ 8] Khraisat A Hashimo o A Nomura S Miya awa O Efe t of lat eral cyclc lo ding on

a utment sc ew lo sening of an ext ernal hex g on implant sy st em J.Pros thet Den 2 04, 9 (4 )

p 3 6– 34

[ 9] Kim S.K Koak J Y He S.J T aylor T.D Ryoo S L e S Y S r w lo sening with int er hang ea le

a utment in int ernaly con e t ed implant aft er cyclc lo ding In J Oral Max iloac Impla ts

2 1 , 27 (1) p 42 47

[1 ] Ya o K.T Ka o H.C Cheng C.K Fang H.W Yip S.W Hsu M.L The efe t of clockwise an

count er lockwise twis ing moment on a utment sc ew lo sening Cln.Oral Impla ts R es 2 1 ,

23(1 ) p 1 8 – 1 6

[1 ] Piermatti J Yousef H Luke A Ma evich R Weiner S An in vitro analy sis of implant

sc ew t orq e los with ext ernal hex an int ernal con e tion implant sy st ems Impla t Den

2 06, 1 (4 ) p 427 –43

[1 ] Wat anab F Torsion t es at heint erfac between implant an a utment Confe enc Pro ram

of 1 th Biennial Me ting of Int ernational Coleg e of Pros hodontis s Ca e Town, South Africa

1 – 3S p 2 0 , p 1 2 1 3

[1 ] Jorge J.R Bara o V.A Delb n J.A As unca o W.G The role of implant/a utment on t orq e

maint enanc of r t ention sc ew s and ve tical misf it of implant-sup ort ed c owns befor an

aft er cycl ng In J.Oral Max iloac Impla ts 2 1 , 28 (2) p 41 –42

[14 ] Ra g r t B Jemt T Jörneus L F r es an moment on Brånemark implant In J Oral

Max iloac Impla t 1 89, 4 (3)p 241– 247

[1 ] Yokoyama D Shinya A Las ila L V Gomi H Nakasone Y Val it u P.K Shinya A

Framework design of an ant erior f iber-r infor ed hy brid comp sit e f ix ed p rtial dentur : a 3D

finit e element tu y In J Pros th do t 2 0 , 2 (4 ) p 40 –41

[1 ] Jemt T & Pe t rs on P A 3-year fol ow-up s u y on single implant tr atment J Den 1 9 ,

21 (4 ) p 2 3– 20