Tiêu Chuẩn Iso 09173-1-2016.Pdf

© ISO 2016 Dentistry — Extraction forceps — Part 1 General requirements Médecine bucco dentaire — Daviers — Partie 1 Exigences générales INTERNATIONAL STANDARD ISO 9173 1 Third edition 2016 10 15 Refe[.]

Dentistr y — Ex traction for c eps —

Part 1:

Médecine b c o-dentaire — Da iers —

Partie 1: Exigence s g n rale s

T ir d edition

2 16-1 -1

Reference n mb r

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 an definitions 1

4 Req irements 2

4.1 Mate ials 2

4.1.1 C mp nent p rts an fas ening comp nent 2

4.2 Max imum o eral leng th 2

4.3 Rockwel har dnes 2

4.4 Surfac finish 2

4.4.1 A ll surfac s 2

4.4.2 Beaks 3

4.5 Resis anc to repr oc s ing 3

4.6 Joint o ening /closing for ce 3

4.7 Joint mo ement 3

5 Test metho s 3

5.1 Visual inspe tion 3

5.2 Resis anc to repr oc s ing 3

5.3 Joint o ening /closing for ce 3

5.4 Joint mo ement 3

6 Mar king 4

Biblog raphy 5

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 6, Denti s tr y, Subcommitt ee SC 4, Dental

ins truments

This third edition canc ls an r plac s the se on edition (ISO 9 7 -1:2 0 ), w hich has be n t ech icaly

r vised with the folowing chang es:

a) as r proc s ing t es , only the aut ocla e t es was sele t ed;

b) ther proc s ing cycles wer inc eased t o 1 0 cycles;

c) theb i ng wat er t es was delet ed

ISO 9 73 consis s of thefolowing p rt , un e the g ene al title Denti s try — Ex trac tio frc eps:

— Part 1: G ene al r q ir ments

— Part 2 : Des ig atio

— Part 3 : Des ig

This r vision of ISO 9 7 -1 is int en ed t o co e al extraction for eps used in dentis ry

Dentistry — Ex traction forc eps —

Part 1:

This p rt of ISO 9 73 spe if ies the g ene al pe formanc r q ir ment for extraction for eps used in

dentis ry

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 try — Voc ab lar y

ISO 6 0 -1, Metal c mate ials — Rockwel h rdnes s tes t — Part 1: Tes t meth d (sc ales A, B, C,D, E, F,G ,H,

K, N, T)

ISO 17664, Ste ii zatio o medic al dev ic es — In ormatio to be prov ided b the ma u ac tur r fr the

proc es s in o r s te ii za le medic al dev ic es

3 Terms and definitions

F or the purposes of this document, the t erms an def initions given in ISO 1 42 an the folowing a ply

3.1

extractio for eps

ty e of pinc rs used for the extraction of t eeth

3.2

be k

fu ctional working en of for eps w hich enclose the t eeth

3.3

facial be k

beak that is designed t o be in contact with the facial surfac of the t ooth

3.4

l ngual be k

beak that is designed t o be in contact with the lngual surfac of thet ooth

3.5

be k separatio

minimum g p betwe n beak tips with the extraction for eps closed

3.6

o eral be k length

dis anc from beak tip t o piv t c ntr

fastening compo ents

comp nent of the extraction for eps used for fast ening the pinc rs

E AMP E Pins, rivets an s rews

4.1 Mater ials

4.1.1 C mpo ent parts and fastening c ompo ents

Al s ainles st eel comp nent shal conform t o the r q ir ment of 4.2 t o 4.6 Ex mples of suita le

s ainles st eels can be fou d in ISO 7 5 -1

4.2 Max imum overal leng th

The ma imum o e al length of extraction for eps shal not ex ce d 2 0 mm

Dimensions in milimetr es

Key

2 joint

3 han le

Figure 1 — General des ription of extraction for eps

The component part of the extraction for eps, with the ex ception of the fast ening comp nent , shal be

heat tr at ed t o at ain a R ockwel hard es v lue of 40 HRC t o 5 HRC w hen det ermined in ac ordanc

with ISO 6 0 -1

Mating surfac s on the same extraction for eps, such as those on o p sit e beaks, shal not v ry in

hard es b mor than 3 u it on the R ockwel hard es scale C

4.4 Sur fac e finish

4.4.1 A ll sur fac es

Al surfac s shal be fr e from surfac defe t an r sid es an shal also be fr e from any

non-fu ctional sharp edg es, inclu ing bur s or flash

Tes in ac ordanc with 5.1

4.4.2 Be ks

When the inne or c own spac of the extraction for eps is se rat ed or t extur d, the se ration or t extur

shal be consist ent within any one patt ern ofextraction for eps

Tes in ac ordanc with 5.1

4.5 Resistanc e to r eproc es ing

The extraction for eps shal show no evidenc of cor osion an shal comply with al the r q ir ment

in this p rt of ISO 9 7 aft er 1 0 r proc s ing cycles, as r commen ed b the man factur r

Tes in ac ordanc with 5.2

NOTE Dis olouration d e to water marking do s not constitute evidence of cor osion

4.6 Joint opening /closing forc e

The joint of the extraction for eps shal be so cons ruct ed that the extraction for eps o ens an closes

smo thly

The t orq e r q ir d t o o e at e shal be between 0,2 Nm an 0,68 N m

Tes in ac ordanc with 5.3

4.7 Joint movement

The e shal be no pe c ptible sideway s mo ement in any p sition of the joint betwe n fuly closed an a

ma imum han le o ening of 5 mm w hen t est ed ac ording t o 5.4

5.1 Visual inspection

V isual inspe tion shal be car ied out un e normal vision, without ma nification

5.2 Resistanc e to r eproc es ing

Car y out 1 0 r proc s ing cycles as r commen ed in the man factur r’s ins ructions, in ac ordanc

with ISO 17664 V isualy inspe t for any signs of cor osion R et es for r q ir ment as in 4.3 an 4.7

F or the purp se of this t es , a r proc s ing cycle inclu es the methods of cleaning, disinfe tion an

st eri zation

5.3 Joint opening /closing forc e

Mount he extraction for eps in a suita le a paratus t o o tain a han le o ening of 5 mm Ap ly a for e

jus suff icient t o close the extraction for eps fuly an r cord the moment of this for e

Comp r the v lues o tained with the lmit given in 4.6

5.4 Joint movement

Grip each han le en between the in ex f ing er an th mb of each han , an a ply a for e pe pen icular

t o the hing e a is

6 Mar king

Each extraction for eps shal be pe manently marked with the folowing information:

a) name of man factur r an / r bran name;

b) patt ern n mbe ;

c) lot n mbe ;

d) ISO 9 7 (o tional)

Bibl og raphy

[1] ISO 7 5 -1, S rgic al ins trument — Metal c mate ials — Part 1: Stainles s s te l

[2] ISO 9 7 - 2, Denti s try — Ex trac tio frc eps — Part 2 : Des ig atio

[3] ISO 9 7 -3, Denti s try — Ex trac tio frc eps — Part 3: Des ig

ICS  11.060.20

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