Tiêu Chuẩn Iso 11608-7-2016.Pdf

© ISO 2016 Needle based injection systems for medical use — Requirements and test methods — Part 7 Accessibility for persons with visual impairment Systèmes d’injection à aiguille pour usage médical —[.]

Needle-based injection systems for

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© 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

F reword i v

Introduction v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms an definitions 2

4 Req irements 3

4.1 R isk analysis req irement 3

4.2 General r eq ir ements 3

4.2.1 NISdesig n 3

4.2.2 Packag ing desig n 4

5 Test metho s 4

5.1 Ve ification tes ing 4

5.2 Summative ev luation (v ldation tes ing ) 5

5.2.1 General 5

5.2.2 Use p pulations 5

5.2.3 C ntex t of use 5

6 Test rep r t 5

7 Infor mation sup led b the manufacturer 6

7.1 General 6

7.1.1 Ove view 6

7.1.2 Tactie information 6

7.1.3 Auditory information 6

7.1.4 Information pr ovided in ele tronic format 6

7.2 Mar king 6

7.2.1 Mar king on the NIS 6

7.2.2 Mar king on the u it packag ing 7

7.3 Ins ructions for use 7

A nne x A (informative)Me sur ing visio and visual impair ment: F nctio al vision and visual acuity 9

A nne x B (informative)Guidanc e for develo ing instructio s for use for per o s w ith visual impairment 13

A nne x C (informative) Pr oc es for establshing a specificatio , test metho s and verification related to 5.1 15

Biblog raphy 18

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 sp nsible 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

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for this document is ISO/TC 84, Devic es fr admini s tratio o medic in l

produc ts a d c athete s

ISO 1 6 8 consis s of the folowing p rt , u de the g ene al title Ne dle -b s ed injec tio sys tems fr

medic al us e — R eq ir ment a d tes t meth ds:

— Part 1: Ne dle -b s ed injec tio sys tems

— Part 2 : Ne dles

— Part 3 : Fini shed c ontaine s

— Part 4: Ne dle -b s ed injec tio sys tems c ontainin elec tro ic s

— Part 5: Automated f nc tio s

— Part 6 : On-b dy deliver y sys tems

— Part 7: Ac c es s ibi t y fr pe s ons w ith v i s ual imp irment

Prior t o this p rt of ISO 1 6 8, the ISO 1 6 8se ies has not pro ided guidanc t o ad r s the use of NIS

b pe sons with visual imp irment The r al ty, however, is that a significant n mbe of NIS use s ha e

visual imp irment an o e at e these devic s, even though the use int erfac s r ly primari y on visual

commu ication t o pro ide the information ne ded for safe an efe tive use The r sult is that use s

with visual imp irment ha e difficulty an ma be at gr at er risk w hen using these prod ct

Given the pr v lenc of visual impairment an the fact that many NIS targ et disease s at es (e.g

dia et es) with co-morbid con itions that can imp ir vision, efort should be made t o el minat e or

minimiz , w he e p s ible, devic featur s that cons itut e o s ructions t o prod ct use for use s with

visual impairment

This part of ISO 1 6 8 defines t erms r lat ed t o visual imp irment and pro ides guidanc t o ena le

man factur rs t o pro ide information t o the use in othe sensory format (e.g tactie, a udit ory) New

an exis ing featur s that ad r s the ne dsof use s with visual imp irment wi l also benef it a bro de

p pulation

The purp se of this p rt of ISO 1 6 8 is t o as is man factur rs in develo ing NIS designs that wi l be

usa le for use s with visual imp irment but r co niz s that those designs could be mor usa le also

for use s with no visual imp irment Taking this ty e of “ unive sal design”

[2 ]

a pro ch is pr fe a le t o

the c eation of “ niche” prod ct only for use s with visual impairment, for w hich the market would be

smale and, conseq ently, the prod ct cos lkely would be highe Ap lying unive sal design principles

t o ext en ac es t o use s with visual impairment can inc ease the market siz , the eb r d cing

prod ct cos an ena lng a bro de p tient p pulation t o ac es the NIS

F or prod ct design purp ses, it should be as umed that some use s wi l ha e mode at e visual

imp irment but wi l be a le t o r ad larg e print and se high-contras prod ct featur s Othe use s,

howeve , wi not be a le t o make use of any visual featur s an wi l inst ead r q ir information t o

be pro ided through othe sensory means (e.g tacti e or au it ory) The efor , this p rt of ISO 1 6 8

inclu es the r q ir ment t o pro ide information in visual format that can be pe c ived an u de st ood

b peo le with mode at e visual imp irment and in non-visual format (e.g tactieor au it ory) that can

bepe c ived an u de st ood b peo le with no useful vision

In conju ction with othe p rt of the ISO 1 6 8 se ies, man factur rs ar ex e t ed t o folow a

risk-b sed a pro ch an emplo h man fact ors engine ring d ring the design, develo ment, an

man factur of NIS se ving this important use p pulation Exis ing prod ct an those cur ently

un e develo ment ma not fulf il some of the r q ir ment given b this p rt of ISO 1 6 8 Howeve ,

man factur rs would be wel advised t o folow it pro isions w hen impro ing exis ing prod ct or

develo ing new prod ct t o o tain a highe level of ac es ibi ty

Guidanc on transition pe iods for implementing the r q ir ment of this Int ernational Stan ard is

given in ISO/TR 1 244

Needle-based injection systems for medical use —

Part 7:

This p rt of ISO 1 6 8 spe ifies p rticular r q ir ment t o make ne dle-b sed drug delve y sy st ems

or NIS (ne dle-b sed inje tion sy st em) ac es ible for pe sons with visual imp irment It a ples t o

devic s int en ed for p tient or car give adminis ration of medicinal prod ct t o h mans

This p rt of ISO 1 60 co e s r q ir ment t o alow for safe an cor e t han l ng of the NIS, inclu ing

la el ng, p cka ing, and ins ructions for use It also inclu es r q ir ment for training pro rams, if

a plca le

This p rt of ISO 1 6 8 co e s r q ir ment for NIS that ar claimed t o be a pro riat e for use b

pe sons with visual impairment

This p rt of ISO 1 60 does not ad r s r q ir ment for use of sharps containe s b pe sons with

visual impairment

Although spe ifical y int en ed t o a ply t o ne dle-based inje tion sy st ems within the ISO 1 60 se ies,

this p rt of ISO 1 6 8 can be a pled t o NIS out ide the ISO 1 6 8 se ies as wel , if they might be used

b pe sons with visual impairment

This part of ISO 1 60 is writt en t o ad r s the ne ds of pe sons with al levels of visual l mitations,

inclu ing low, mode at e, or seve e visual impairment ; leg l, fu ctional, or t otal bl n nes ; an colour

vision def iciencies

The efor , this p rt of ISO 1 6 8 inclu es the r q ir ment t o pro ide information in visual format

that can be pe c ived an u de st ood b peo le with mode at e visual imp irment an in non-visual

format (e.g tactie or au it ory) that can be pe c ived an u de st ood b peo le with no useful vision

F or simpl city’s sake, this rang e is desc ibed in this p rt of ISO 1 6 8 as ad r s ing the ne ds of

in ivid als with mode at e visual imp irment or bl n nes

NOTE NIS that are not claimed to b ap ropriat e for use by per ons with visual impairments ne d not me t

these req irements, but man facturer are encoura ed to consider them

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 6 8-1:2 14, Ne dle-b sed injec tio sys tems fr medic al us e — R eq ir ments a d tes t meth ds —

Part 1: Ne dle -b s ed injec tio sys tems

ISO 149 1, Medic al dev ic es — Ap lc ation o ri sk ma a ement to medic al devic es

IEC 6 3 6-1,

1)

Medic al dev ic es — Part 1: Ap lc atio o us abi t y en ine rin to medic al dev ic es

1) Replaces IE 62 6

3 Terms and definitions

F or the purposes of this document, the fol owing t erms and def initionsa ply

3.1

colour vision deficiency

ina i ity t o dis inguish c rtain shades of colour or in mor seve e cases, se colours at al

3.2

bl n nes

vi s ual ac uit y (3.1 ) les than 3 6

Not e 1t o entry: Having no useful vision

Not e 2t o entry: S e Ta le A.1

3.3

functio al vision

wa in w hich a pe son fu ctions w hen att empting visual tasks, such as r ading, orientation an

mo i ity, activities of daiy lving, visual communication, an visual jo ski s

3.4

functio al visual impairment

significant lmitation of visual ca a i ity that can ot be impro ed b cor e tive lenses, medications, or

surg ery, an r sult in diff iculty ac omplshing visual tasks that ar imp rtant t o the in ivid al

Not e 1t o entry: S e An e A

3.5

mo erate visual impairment

vi s ual ac uit y (3.1 ) betwe n 6 / 18an 6 /6

Not e 1t o entry: S e Ta le A.1

3.6

ne dle-based injection sy stem

NIS

inje tion sy st em int en ed for p r nt eral adminis ration b inje tion of medicinal prod ct using a

ne dle an a multi-dose or single-dose containe

[ SOURCE:ISO 1 6 8-1:2 14, 3 9]

3.7

no -visual me ns

format that uti iz s a sensory channel othe than vision

Not e 1t o entry: Braile is not widely used; therefore,it is not recommen ed as the only tactile format

Not e 2t o entry: Ex mples of non-visual me ns are chan els for e.g tactile, au it ory, olfact ory sensor

3.8

severe visual impairment

vi s ual ac uit y (3.1 ) betwe n 6 /60 an 3 6

Not e 1t o entry: S e Ta le A.1

3 9

user interface

means b w hich the use an the medical devic int eract

[ SOURCE:IEC6 3 6-1:2 1 , 3.2 , modified]

visual acuity

sharpnes of vision ex r s ed as a fraction of normal vision

Note 1t o entry: S e An e A

E AMP E T e notation “6 / 12” me ns that a specif ic per on can distinguish an ima e at a distance of 6 m

that a per on with normal vision could distinguish at a distance of 1 m

3.1

visual impairment

sight los that cannot be impro ed b cor e tive lenses

Note 1t o entry: Cor ective lenses can b glas es or contact lenses

4.1 Risk anal ysis requirements

The man factur r’s risk as es ment shal conside risks as ociat ed with the int en ed use of the NIS

for medical purposes, inclu ing use b in ivid als without visual imp irment, as wel as in ivid als

with mode at e visual imp irment an in ivid als with bl n nes

When con ucting the risk as es ment, it is imp rtant t o ac urat ely identify al use groups of the NIS

an any fu ctional charact eris ics of each group that could afe t their use of the NIS Some disease

con itions (e.g dia et es) an some medications(e.g thorazine) can cause visual impairment an some

use groups (e.g elde ly ad lt , w ho might be the p tient or a la car give ) ar mor lkely t o ha e

visual imp irment Some use sof the NIS might ha e colour def iciency, w hich could be as ociat ed with

othe ty es of risks If the e is a p s ibi ty of visual imp irment amongs the NISuse groups, analy sis

of the p t ential efe t of those imp irment on the use s’ int eractionswith the NIS shal be inclu ed in

the risk as es ment

As part of the risk analy sis con uct ed ac ording t o ISO 149 1, the man factur rs shal identify al use

sc narios that could lead t o a hazardous situation or harm an then implement risk control measur s

ne ded t o r d c the risks t o ac epta le levels The adeq acy of the risk control measur s shal be

as es ed in the summative ev luation of the NIS S e 5.2

The as es ment of the risks and benef it as ociat ed with use of the NIS shal conside the fact that

for use s with visual imp irment, the risks might be dife ent from the risks for use s without visual

imp irment The analy sis of risks shal inclu e han lng of the NIS, ac urat e dosing of the spe if ic

drug, an u de s an ing of the information sup led b the man factur r Whie the benef it of the

medicinal prod ct ar the same for b th use groups, the benefit could be gr at er for use s with visual

imp irment d e t o the a i ty t o self-administ er the medicinal prod ct

4.2 General requir ements

4.2.1 NIS desig n

The NIS shal be designed so that a use with mode at e visual imp irment or bl n nes can use it afely

an cor e tly for it int en ed purpose, inclu ing, w he e a plca le, fil ing the NIS with medicinal

prod ct an as embl ng comp nent The r q ir ment in this Clause ma be fulf iled through the use

of an ac es ory (e.g sep rat e devic or mo ie a plcation)

NIS shal clearly in icat e an dis inguish the folowing s at es b visual an non-visual means, i.e

pro iding eq iv lent information in othe sensory format , such as tactie an / r au ible format :

— un sed;

— r ady t o delve ;

— del very initiat ed;

— del very complet ed;

— end of useful l fe

NOTE 1 ISO 1 60 -5 uses the t erm “in use”, which inclu es thre of the states list ed a ove: “ re d to deliver,

delivery initiated, an delivery completed”

The NIS design shal me t he fol owing r q ir ment

a) The visual an non-visual information shal be consist ent with each othe Stat e in icat ors shal be

pe sist ent or conf irma le b the use w hie the NIS is in that s at e Whe e a plca le, the NIS shal

alow the use t o det ermine the del ve a le dose b visual an non-visual means

NOT 2 Information presentation can b either per ist ent (constant) or transient (emporary) For

e ample, a contin ous au ible t one would b per istent, where s a single click or “b ep” would b transient

b) The NIS shal alow the use t o as es the a pearanc ofthe medicinal prod ct b visual means, e.g

through as is anc from a sight ed pe son, an w he e p s ible, non-visual means

When the NISr q ir s the use t o pr -set the dose, or the man factur r pr -set the dose, the NIS

shal pro ide an in ication through visual an non-visual means of the dose that has be n set

c) Varia le multi-dose NISs ( y st em designationsA an C, as defined in ISO 1 6 8-1) shal be designed

so that they in icat e, through visual an non-visual means, eithe the amount of the pr -set dose

del ve ed or the amount of the pr -set dose not yet delve ed

d) If the NIS contains b tt eries, it shal be designed t o alow the use t o det ermine the r maining

batt ery charg e b visual an non-visual means

e) The NIS shal ena le the use t o safely identify the location from w hich sharps wi l proje t using

visual an non-visual means Whe e r traction of the ne dle from the inje tion sit e is aut omatic,

in ication of the completion ofne dle r traction shal be pro ided b non-visual means If a tactie

means is used t o identify and verify s atus of the ne dle, it shal be designed in such a wa that he

use of the tactie means it elfwi l not lead t o inc easing risk of ne dle s ick injury

4.2.2 Packag ing desig n

The NIS p cka ing shal be designed so that a use with mode at e visual imp irment or bln nes can

o en it safely an cor e tly, without being harmed or dama ing the NIS

F eatur s pro ided t o faci itat e o ening the p cka ing shal be r adiy a par nt b visual an at leas

one non-visual means

The packa ing shal be designed t o pr vent inadve t ent spi ag e of the packag e cont ent onc the

p cka ing iso ened

If as embly of the NIS is r q ir d, the comp nent shal be p ckag ed in a wa that faci itat es cor e t

identification an as embly

5.1 Verification testing

Tes ing shal be con uct ed t o ve ify that the NIS design was implement ed in ac ordanc with the design

spe ifications, inclu ing those featur s that make the NIS safe an efe tive for use s with visual

imp irment

Spe ifications for fu ctions r lat ed t o ac es ibi ty, such as o e ating rang es, ma imum an / r minimum

levels, an dimensional v lues of t ech ical p ramet ers shal be ve if ied F or furthe information, se

An ex C

Whi e la -b sed t es ing an measur ment of the ac es ibi ty-r lat ed use int erfac featur s can form

p rt of a ve if ication pro ram for the prod ct, NIS man factur rs shal be awar that a pro riat e

formative an summative v ldation wi pro ide final evidenc that the int en ed use s can use the NIS

safely an cor e tly

5.2 Summati ve evaluation (val dation testing )

5.2.1 General

Whe e the int ended use groups ar identified as inclu ing peo le with visual imp irment, such use s

shal be inclu ed in summative ev luation con uct ed on the NISan it p cka ing an la el ing

The summative ev luation of the NIS shal be con uct ed ac ording t o IEC 6 3 6-1 an inclu e the use

p pulations an cont ext of use

5.2.2 Use pop lations

Summative ev luation of a NIS that folow s this p rt of ISO 1 6 8 shal inclu e the int en ed use s

F or the purp ses of r c uiting peo le with visual impairment t o p rticipat e in summative ev luation of

a NIS, an charact erizing their level of impairment, measuring fu ctional vision might be simple an

mor a pro riat e and useful than measuring visual acuity Stan ardiz d ins rument ar a ai a le for

this purp se The man factur r shal pro ide a rationale for their choic t o measur eithe fu ctional

vision or visual acuity, an the spe if ic measur ment ins rument ele t ed S e Annex A

5.2.3 C ntex t of use

The cont ext ofuse for the NIS shal be conside ed in the risk as es ment Al aspe t of the cont ext of

use that could afe t use s’ a i ity t o use the NIS safely an cor e tly shal be incorp rat ed int o the

summative ev luation

Aspe t of the cont ext of use that ar p rticularly important t o use s with visual impairment inclu e

any environmental con itions that could afe t use s’ pe c ption of information F or ex mple, l ghting

con itions (e.g low lght or glar ) can afe t the a i ity of use s with mode at e visual imp irment

t o pe c ive visual information pro ided b the use int erfac Ambient noise levels an acous ic

charact eris ics of the environment (e.g r ve be ation) can afe t the a i ity of use s t o pe c ive

au it ory information pro ided b the use int erfac Cold t empe atur s can afe t use s’ a i ty t o

pe c ive tacti e information

Anothe aspe t ofthe cont ext of usethat is p rticular t o use s with visual imp irment is use of as is ive

t ech olo ies Some use s wi l use glas es or ma nifying t ech olo ies t o pe c ive visual information

Some use s wi l use sou d ampl fie s t o pe c ive au it ory information

6 Test r eport

S e ISO 1 6 8-1 an IEC 6 3 6-1

7 Information suppl ed by the manufactur er

7.1.1 Overview

Al visual information r q ir d for safe an efe tive use of the NIS shal be pe c ptible an

compr hensible t o use s with mode at e visual imp irment Use s with bln nes shal be a le t o

ac es the same information through non-visual means The visual an non-visual information shal be

consist ent with each othe

7.1.2 Tacti e information

Information can be commu icat ed through tacti e means

Tactie information can be pro ided in format such as raised charact ers, vibration, dis inctly sha ed

controls, brai e, an othe featur s The efe t of deg ene ative diseases an neuro athy in the p tient

p pulation of the int en ed NIS shal be conside ed in the design of any tacti e commu ication methods

NOTE S e ISO/TR 2 411:2 0 , 8.2.2.1 for guidance on suita le tactile markings ISO/TR 2 411:2 0 ,

9.2.3.2,9.2.3.3 an 9.2.4 provide guidance on the spatial an t emporal resolution of the tactile sense, as wel as

the thermal sense ISO 245 3 provides req irements for improving the ac es ibility of consumer prod cts used

by per ons with visual impairment, an in cases where visual information is not the primary sense used for

ac omplishing the task

7.1.3 Auditory infor mation

Information can be commu icat ed b au it ory means

A udit ory information can be pro ided in format such as synthesiz d or r corded spe ch, melodies,

clcking, be ping, or buz ing

NOTE S e ISO/TR 2 411:2 0 , 8.2.2.2 for guidance on efective design of au itory fe db ck ISO 245 0

provides guidance for improving the usa ility an ac es ibility of au itory signals used in consumer prod cts,

there y facilitating use by al pe ple, inclu ing pe ple with visual impairments an older pe ple with a

e-related he ring impairments ISO 245 1 specif ies methods for determining an ap ropriate sou d level rang e for

au it ory signals, so that al prod ct user , inclu ing pe ple with a e-related he ring los , can he r them properly

a ainst interfering sou ds

7.1.4 Infor mation provided in electronic for mat

Information can be commu icat ed through ele tronic means

Ele tronic information can be pro ided in format such as codes or signals int en ed t o int eract with

han -held devic s, dedicat ed r ade s, or as is ive t ech olo ies

NOTE One e ample of an electronic marking is a QR (q ick response) code, which is a form or optical y

machine-re da le ima e that convey s information such as t ext or a website ad res ISO/IE 1 0 4 def ines the

req irements for the symb lo y, k own as QR Code 2 0

7.2 Mar king

7.2.1 Mar king o the NIS

The NIS markings shal ena le the use t o ac es the same information r q ir d in ISO 1 60 -1:2 14,

1 2.2, b non-visual means

Flashing, bl n ing, sc ol ng, or flckering display s can be difficult for use s with mode at e visual

imp irment t o r ad Dis racting or un e es ary information should not be pr sent ed t o the use

NOTE 1 T e fol owing International Stan ards provide useful guidance:

— ISO/TR 2 411:2 0 , 8.5, 8.6 an 8.8 provide usefulguidance on improving le ibility an comprehension of

te t an grap ic markings

— ISO 245 2 provides a method of calculating a e-related luminance contrast hat can b used for as es ing

an designing signs an visual display s so that they are cle rly visible to older pe ple

NOTE 2 T e risk as es ment could in icate that the NIS markings should ena le the user t o distinguish it from

similar NIS in the same en ironment

7.2.2 Mar king on the unit packag ing

The markings on the packa ing shal ena le the use t o ac es the same information r q ir d in

ISO 1 60 -1:2 14, 1 2.3 b visual an at leas one non-visual means

Markings shal be r adi y locata le b non-visual means an comp tible with as is ive r ading

t ech olo ies

NOTE Tech olo ies that might b used to re d the packa ing markings inclu e as istive re ding tech olo ies

that utilize machine-re da le code, webbrowser lin s t o websit es, telep one, an / r ma nif ication

7.3 Instructions for use

Al information in the ins ructions for use shal be a aia le t o use s with visual imp irment

This information shal be pro ided through visual means usa le b pe sons with mode at e visual

imp irment and through at leas onenon-visual means

The ins ructions for use shal inclu e information in clear languag e t o faci tat e use of the NIS b

pe sons with visual impairment, inclu ing r fe enc t o al non-visual information pro ided b an

markings on the NIS F or ex mple, w he e a plca le, the folowing information shal ex lain how t o,

safely an cor e tly,

— r mo e the p rt of the NIS from the p cka ing,

— identify the part of the NIS an ne es ary consuma le comp nent an as emble them cor e tly,

— det ermine how much medicinal prod ct is in the NIS,

— f il the devic with the medicinal prod ct,

— combine sep rat e component of medicinal prod ct ,

— cond ct priming st eps or othe dose delve y pr paration,

— set the dosag e in the NIS,

— del ve a complet e dose with the NIS,

— det ermine how much medicinal prod ct was delve ed b the NIS,

— r mo e an r ins al r plac a le comp nent ,

— disas emble the NIS,

— disp se of the NIS or consuma le comp nent ,

— det ect the cor e t orientation of the b tt ery or batt eries, an

— pe form troublesho ting