Tiêu chuẩn iso ts 16955 2016

© ISO 2016 Prosthetics — Quantification of physical parameters of ankle foot devices and foot units Prothèses — Quantification des paramètres physiques des dispositifs de cheville/pied et unités pour[.]

Prosthetics  —  Quantification  of 

Prothè se s  — Qu ntif ation de s p ramètre s p ysique s de s dispositifs 

de cheville/pied et u ités p ur le s pieds

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© ISO 2016, P blshed in Sw itz rlan

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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

F reword i v

Introduction v

1 Sc ope 1

2  Nor mati ve r eferenc es 1

3  Terms and definitions 1

4 Symbols and abbreviated terms 2

5 Req irements 2

6 S tup c onditions 2

7  Quantificatio 3

7.1 He l, mid-fo t an toe characte is ics 3

7.1.1 Pr oc d re 3

7.1.2 Data cole tion and calculations 4

7.2 Rol-o e characte istics 5

7.2.1 Pr oc d re 5

7.2.2 Data cole tion and calculations 6

7.3 Torsional char acte is ic 7

7.3.1 Pr oc d re 7

7.3.2 Data cole tion and calculations 8

7.4 Fr ontal plane char acte is ics 8

7.4.1 Pr oc d re 8

7.4.2 Data cole tion and calculations 9

8 Ac c es ories 10

8.1 General 1

8.2 Pr oc dure 1

8.3 Result 1

A nne x A (informative) Quick referenc e 11

A nne x B (informative) Thr ee dimensional locus of for c e c ontact point on fo t-sole 12

Biblog raphy 17

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 thisdocument is ISO/TC1 8 Pros thetic s a d orth tic s

— a) iso vious an defined b the fo twear,

— b) is spe if ied in ISO 2 5 3 r fe ring t o ISO 2 6 5 (but is not suita le for use as a guide for the

sele tion of a spe ific an le-fo t devic or fo t unit in the pr sc iption of an in ivid al lowe lmb

pros hesis), an

— c) is ad r s ed in this Te h ical Spe ification

The AOPA group of ISO/TC 1 8 membe s betwe n 2 0 an 2 0 car ied out work on a method t o

r plac design c it eria for pros hetic an le-fo t devic s with complanc c it eria w hich would be

a plca le t o b th joint ed devic s an u joint ed devic s with elas ic element In 2 1 , the working

group“Tes ing” convened in S at le, Washingt on an de ided t o work on a s an ard, b sed on the work

of the AOPA group an othe int ernational groups The vision s at ement was: “To develo a s an ard

w hich desc ibes q antitative methods t o ev luat e or as es key pe formanc in icat ors of pros hetic

an le-fo t devic s w hich ar cor elat ed t o measura le pros hesis use benefit.”

The subseq ent work on this task has made it clear that it consis s of (at leas ) two element : firs ly,

t o develo a s an ard w hich desc ibes q antitative methods t o ev luat e or as es key pe formanc

in icat ors an se on ly, t o inves ig t e and att empt t o es a lsh the cor elation betwe n these measur s

an r lev nt measur s of pros hetic use benefit This Te h ical Spe ification desc ibes solely the

q antitative methods t o ev luat e or as es key pe formanc in icat ors

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 ment

— “ hould” indicat es a r commen ation

— “ ma ”is used t o in icat e that omething 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

In 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 il ed if compl anc with the document is t o be

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

In 3.3.2 of the ISO/IEC Dir ctives, Part 2 ( ixth edition, 2 1 ) def ines a r commen ation as an

“ex r s ion in the cont ent of a document conveying that among seve al p s ibi tiesone 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 ity or course of

action is depr cat ed but not prohibit ed.”

Prosthetics  —  Quantification  of  ph ysical  parameter s  of 

ankle  foot  devic es  and  foot  units

This Te h ical Spe ification desc ibes q antitative methods t o ev luat e or as es key pe formanc

in icat ors of pros hetic an le fo t devic s

F or each method, the set-up an t es configurations ar desc ibed Also inclu ed is a v riety of

p ramet ers w hich ar de ived or calculat ed from the r corded data

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 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 3 8, Pros thetic s — Struc tural tes tin  o lowe - mb pros thes es — R eq ir ments a d tes t meth ds

ISO 2 5 3:2 0 , Ex te n l lmb pros theses a d ex te n l orth s es — R eq ir ments a d tes t meth ds

ISO 2 6 5:2 1 , Pros thetic s — Tes tin  o a kle -fot devic s a d fot u it  — R eq ire me nt  a d tes t meth ds

3  Terms and definitions

F or the purposes of this document, the folowing t ermsand definitions a ply

3.1

he l, mid-fo t and toe characteristic

phy sical p ramet ers t o desc ibe the r sp nse of the an le fo t devic un e lo d aft er he l s rike in

mid s anc an prior t oe of

3.2

rol -ove characteristic

phy sical p ramet ers t o desc ibe the sa it al plane pro e ties of the ankle fo t devic r lev nt for the

p tient d ring s anc -phase

3.3

ful  co tact motio

phy sical paramet er t o desc ibe the angular rang e of motion of the shin w he e the he l an the t oe ar in

contact with the groun simultaneously

3.4

tor ional characteristic

phy sical p ramet er t o desc ibe the rotational r sp nse of the an le fo t devic un e lo d an

ad itional t orq e in transve sal plane

3.5

fro tal plane characteristic

phy sical p ramet er t o desc ibe the frontal plane r sp nse of the an le fo t devic d ring rol o e on

four dife ent tit ed groun angles in frontal plane

4 Symbols and abbr eviated terms

Symb ls an a br viat ed t erms ar those used in ISO 1 3 8 an ISO 2 6 5

To det ermine compr hensive ankle fo t devic pe formanc an t o claim complanc with this

Te hnical Spe ification, al p ramet ers shal be q antif ied an the s r ngth r q ir ment spe ified in

ISO 2 5 3:2 0 , 4.4, shal be met

If an an le fo t devic alow s for dife ent adjus ment on key pe formanc in icat ors, the

man factur r/submitt er shal define the set ings r lev nt or q antif ication To claim compl anc with

this Te hnical Spe if ication, al p ramet ers shal be q antif ied in the spe if ic adjus ment an the

s r ngth r q ir ment spe ified in ISO 2 5 3:2 0 , 4.4, shal be met

Samples for the q antification shal be from the same prod ction b t ch as those for s r ngth t es ing

If not othe wise spe if ied in this Te hnical Spe if ication, the t es pr p ration as desc ibed in ISO 1 3 8

locat ed at 7 0 mm height on a lne w hich islocat ed at midfo t an p ralel t o the u-a is

The t es methods spe ified ar defined for a pros hetic fo t of siz 2 cm an a pro riat e for a 7 kg

amput ee

F or al the desc ibed t es methods, a for e moment ensor shal be positioned a o e midfo t an at the

height of 5 0 mm, se Figur 1

In orde t o q antify the influenc of complant comp nent between k e an ankle fo t devic , the

for e moment sensor is positioned at a height of 5 0 mm

A displac ment sensor rigidly conne t ed t o the for e moment sensor p ralel t o u-a is shal be used t o

r cord ve tical displac ment s

u)

An angular sensor rigidly conne t ed t o the for e moment sensor pe pen icular t o u-a is shal be used

t o r cord the t orsional angle (α

u)

Using the data acq ir d b the sensors, the folowing charact eris ics shal be calculat ed

l

= (ΔF

u/Δ s

u)

— Leve arm length at s atic plat e angle l = ( M

o/ F

u)

NOT Calculations in rang s of F

u

<1 % F

uma

t o b considered carefuly b cause of noise

— Leve arm length chang es at tatic plat e angle Δl = l

2-

1

2-α

1

— Ene g at s atic plat e angle E = ∫ F

u)

u

= Δ

u2-Δα

Pe form the q antif ication of the he l, mid-fo t an t oe charact eris ics using the g eometrical

conf iguration of fo t an fo t platorm desc ibed for lo ding in ISO 2 6 5:2 1 , 1 4.1.3, using plat e

angles of -7,5° an 1 °in ad ition ( e Figur 2)

The peak for e in the lo ding profile for q antif ication of the he l an t oe charact eris ics ( e Figur 3)

shal be in ac ordanc with 1 0% ( 824 N)of the ma imum b dy weight for w hich the ankle fo t devic

is designed The lo ding an u lo ding time shal be within (1 ± 0,1) s

Pe form the q antif ication of mid-fo t charact eris ic as s at ed a o e but with the fo t plat e horizontal

(0° and the peak for e in the lo ding prof ile ( e Figur 3) in ac ordanc with 2 0 % (1 3 3 N) of the

ma imum b dy weight for w hich the ankle fo t devic is designed The lo ding an u lo ding time

shal be within (1 ± 0,1) s

Figure 2 — He l, mid-fo t and toe characteristic  ( i ting  angle of fo t plat orm)

Thelo ding profile shal be a sin soidal wa e with the peak at the spe ified lo d

Figure 3 — L ading  profi e

7.1.2 Data c olection and calculatio s

During the t es , ve tical displac ment (

u), ve tical for e ( F

u) an outward moment ( M

o) shal be

r corded

Using this data the fol owing charact eris ics shal be calculat ed ( e also Ta le 1)

Table 1 — He l, mid-foot and toe characteristic

Pe form the q antification of the rol-o e chara ct eris ics ( e Figur 4) using the geometrical

con guration offo t an fo t platorm an the lo ding profile desc ibed in ISO 2 6 75:2 1 , 1 4.2, except

— a plying the for e of F

1cmabetwe n the plat e angles − 5° an + 20° ( e Figur 5), an

— the d ration of the lo ding profile shal be within 6 0 ms ± 1 %

Figure 4 — Rol -over characteristic

Figure 5 — Loading  profie an  foot plat orm angle

7.2.2 Data c olectio and calculatio s

During the t es , fo t platorm angle(α), ve tical for e ( F

u) and outward moment ( M

o) shal ber corded

Using this data the fol owing charact eris ics shal be calculat ed as shown in Ta le 2

Table 2 — Rol -o e characteristic

Pe form the q antif ication of t orsional charact eris ics using the g eometrical conf iguration desc ibed

in 7.1.1 (mid-fo t charact eris ics) ex cept that the ve tical for e (F

u) is a pl ed at a cons ant level in

ac ordanc with 1 0 % of the ma imum b dy weight (6 7 N) for w hich the an le fo t devic is designed

(Figur 6)

Ap ly the for e prof ile asshown in Figur 7

Ap ly a t orsional moment of − 5 Nm t o + 5 Nm w hie the fo t is u de ma imum lo d (Figur 7)

The t orsional moment time shal be within (1 ± 1)s

Figure 6 — Tor io al characteristic

Figure 7 — F or e and moment profie

7.3.2 Data c olectio and calculatio s

During the t es , t orsional angle (α

u) an t orsional moment ( M

u) shal be r corded

Using this data the fol owing charact eris ics shal be calculat ed as shown in Ta le 3

Table 3 — Tor io al characteristic

Tor ion

1) Tor ional stifnes

2) Tor ional angular rang

7.4 Frontal plane characteristic

7.4.1 Proc edure

Pe form the q antification of the frontal plane charact eris ics ( e Figur 8) using the setup an

prof iles desc ibed in 7.2.1, ex cept

— the titing plate is ti ted s aticaly in the frontal plane in addition to the titing movement in

sa it al-plane,

— thehe l d mmy is mou t ed in the frontal plane angle on t op of the tit ed plat e,

— the frontal angle is set in an angle of ± ° an in an angle of ± 0° t o q antify the medial an lat eral

charact eris ics,

— thejoint in the t op lo d a plcation p int is blocked a ains rotation a out he u-a is

a) S git al b) Fro tal

Figure 8 — Fro tal plane characteristic

Figure 9 — L ading  profie and foot plat orm angula rang e in sa it al plane

7.4.2 Data c olection and calculatio s

During the t es , fo t platorm angle(α), ve tical for e (F

u) and forward moment ( M

fshal be r corded

Using this data the fol owing charact eris ics shal be calculat ed as shown in Ta le 4

Table 4 — Fro tal plane characteristic

Frontal Plane Efective fo t width

Run the t es s spe if ied in Cla use 7 using a r lev nt fo t an the fu ctional comp nent

R epeat he t es s without he functional component

Comp r the r sult in orde t o q antify thefu ctional influenc of the component t o the r lev nt fo t

2) Lever arm length

3) Lever arm length

A nne x B

Three dimensional locus of  for c e c ontact point on  foot-sole

The for e contact p int, fcp, (f

1, u

1, o

1) is calculat ed as the c os point of lne A ( c ew lne calculat ed

from the output of 6-a is lo d c l ) an lne B ( wing fo t plat e surfac ) shown in Figur B.1 a) The

origin is on the c ntr of 6-a is lo d c l Locus of the p int f

1, u

1, o

1) is cor esp nding t o but not eq al

t o the “ rol-o e sha e” used b R efe enc s [1] and [2] The “ rol-o e sha e” is the locus of co (c ntr

of pr s ur ) on the fo t-sole in sa it al plane

Thefor e



F an the moment



M measur d b a 6-a is lo d c l ar p sitioned on the c ntr of the lo d

c l, an ar eq al y trans ormed t o the for e

When the 6-a is lo d c l is p sitioned as shown in Figur B.1 b), the sc ew lne A on the sa it al plane

is ex r s ed as F ormula (B.8) in w hich fis chang ed t o f- f

a This should be a pled t o F ormula (B.1 )