Iec 80369 5 2016

2 An ex F informative Summary of SMAL -BORE CON ECTOR desig req irements f or l mb c ff in ation AP LIC TIONS.. CON ECTORS man factured to the dimen ion set out within this International

Smal - bore connectors for l quids and gases in healthcare appl cations –

Part 5: Connect ors for l mb cuf inflat ion appl cations

R accords de pet ite t ai le pour l quides et gaz ut il sés dans le domaine de la

santé –

Partie 5: Raccords dest inés à des appl cat ions au gonflage de brassard

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Smal - bore connectors for l quids and gases in healthcare appl cations –

Part 5: Connect ors for l mb cuf inflat ion appl cat ions

R accords de pet ite t ai le pour l quides et gaz uti isés dans le domaine de la

CONTENTS

FOREWORD 4

INTRODUCTION 6

1 * Sco e

7 2 Normative ref eren es 7

3 Terms an def i ition 8

4 General req irements 9

4.1 General req irements f or the l mb c f f in ation AP LIC TION

9 4.2 Materials u ed for SMAL -BORE CON ECTORS 9

4.3 TYP T S S 10 5 Dimen ional req irements for sph gmomanometer an c f f SMAL -BORE CONNECTORS 10 5.1 * Req irements f or ad lt or p ediatric PATIENT SMAL -BORE CON ECTORS (S1) 10 5.2 Void 10 6 Perf orman e req irements 10 6.1 Air le kage 10 6.2 * Resistan e to se aration f rom axial lo d 10 An ex A (informative) Rationale an g idan e 1

A.1 General g idan e 1

A.2 Rationale f or p rtic lar clau es an s bclau es 1

An ex B (normative) SMAL -BORE CONNECTORS f or the l mb c f f in ation AP LIC TION 13 An ex C (normative) Ref eren e CONNECTORS 17 C.1 General req irements f or referen e CON ECTORS 17 C.2 * Sph gmomanometer an c f f S1 referen e CONNECTORS 17 An ex D (informative) As es ment of MEDIC L DEVICE an their at ributes with CONNECTIONS within this AP LIC TION 18 An ex E (informative) Summary of the u a i ty req irements for SMAL -BORE CONNECTORS f or l mb c f f in ation AP LICATIONS 19 E.1 US RPROFILE 19 E.2 Use s enarios 19 E.3 Use en ironments an s enarios 2

E.4 Generic US R ne d 2

An ex F (informative) Summary of SMAL -BORE CON ECTOR desig req irements f or l mb c ff in ation AP LIC TIONS 21

An ex G (informative) Summary of as es ment of the desig of the CON ECTORS f or l mb c ff in ation AP LIC TION 2

G.1 General 2

G.2 Summary of the en ine rin analy is of the desig 2

G.2.1 NON-INT R ON ECTABLE analy is 2

I 2 * Test con ition 34

I 2.1 Test sample precon itionin 3

I 2.2 En ironmental test con ition 3

I 3 Ap aratu 3

I 4 PROCEDU E 3

I 5 Test re ort 3

An ex J (informative) Resistan e to se aration f rom axial lo d T S ME HOD 3

J.1 Prin iple 3

J.2 * Test con ition 36 J.2.1 Test sample precon itionin 3

J.2.2 En ironmental test con ition 3

J.3 Ap aratu 3

J.4 PROCEDU E 3

J.5 Test re ort 3

An ex K (informative) Ref eren e to the es ential prin iples 3

In ex of def i ed terms 3

Bibl ogra h 4

Fig re B.1 – Male c f f S1 SMAL -BORE CON ECTOR 13 Fig re B.2 – Female sph gmomanometer S1 SMAL -BORE CON ECTOR 15 Fig re B.3 – Sph gmomanometer an c f f SMAL -BORE CON ECTOR (S1) as embly 15 Fig re H.1 – Obsolete sph gmomanometer an c f f SMAL -BORE CON ECTOR 3

Ta le B.1 – Male c f f S1 SMAL -BORE CON E CTOR dimen ion 14 Ta le B.2 – Female sph gmomanometer S1 SMAL -BORE CONNECTOR dimen ion 16 Ta le E.1 – US R PROFILE 19 Ta le F.1 – Ad lt or p ediatric PATIENT sph gmomanometer an c f f S1 CON E CTOR-sp cif i desig req irements (1 of 4) 21

Ta le F.2 – Ne natal sph gmomanometer an c f f CONNECTOR-sp cif i desig req irements (1 of 4) 2

Ta le G.1 – Summary of p s ible mis on ection from CAD analy is 2

Ta le H.1 – Obsolete male sphy momanometer an c f f SMAL -B ORE CON E CTOR dimen ion 3

Ta le H.2 – Obsolete f emale sph gmomanometer an c f f SMAL -B ORE CON E CTOR dimen ion 3

Ta le K.1 – Cor esp n en e b twe n this doc ment an the es ential prin iples (1 of2) 3

INTERNATIONAL ELECTROTECHNICAL COMMISSION

1 Th Intern tio al Ele trote h ic l Commis io (IEC) is a worldwid org niz tio for sta d rdiz tio c mprisin

al n tio al ele trote h ic l c mmite s (IEC Natio al Commite s) Th o je t of IEC is to promote

intern tio al c -o eratio o al q e tio s c n ernin sta d rdiz tio in th ele tric l a d ele tro ic f i ld To

this e d a d in a ditio to oth r a tivitie , IEC p bls e Intern tio al Sta d rd , Te h ic l Sp cif i atio s,

Te h ic l Re orts, Pu lcly Av ia le Sp cific tio s (PAS) a d Guid s (h re f ter refere to a “IEC

Pu lc tio (s)”) Th ir pre aratio is e tru te to te h ic l c mmite s; a y IEC Natio al Commite intere te

in th s bje t d alt with ma p rticip te in this pre aratory work Intern tio al g v rnme tal a d n

n-g v rnme tal org niz tio s laisin with th IEC als p rticip te in this pre aratio IEC c la orate clo ely

with th Intern tio al Org niz tio for Sta d rdiz tio (ISO) in a c rd n e with c n itio s d termin d b

a re me t b twe n th two org niz tio s

2) Th formal d cisio s or a re me ts of IEC o te h ic l maters e pre s, a n arly a p s ible, a intern tio al

c n e s s of o inio o th rele a t s bje ts sin e e c te h ic l c mmite h s re re e tatio fom al

intere te IEC Natio al Commite s

3) IEC Pu lc tio s h v th form of re omme d tio s f or intern tio al u e a d are a c pte b IEC Natio al

Commite s in th t s n e Whie al re s n ble eforts are ma e to e s re th t th te h ic l c nte t of IEC

Pu lc tio s is a c rate, IEC c n ot b h ld re p n ible for th wa in whic th y are u e or f or a y

misinterpretatio b a y e d u er

4) In ord r to promote intern tio al u iformity, IEC Natio al Commite s u d rta e to a ply IEC Pu lc tio s

tra s are tly to th ma imum e te t p s ible in th ir n tio al a d re io al p blc tio s An div rg n e

b twe n a y IEC Pu lc tio a d th c r e p n in n tio al or re io al p blc tio s al b cle rly in ic te in

th later

5) IEC its lf d e n t pro id a y ate tatio of c nformity In e e d nt c rtific tio b die pro id c nformity

a s s me t s rvic s a d, in s me are s, a c s to IEC mark of c nformity IEC is n t re p n ible for a y

s rvic s c rie o t b in e e d nt c rtific tio b die

6) Al u ers s o ld e s re th t th y h v th late t e itio of this p blc tio

7) No la i ty s al ata h to IEC or its dire tors, emplo e s, s rv nts or a e ts in lu in in ivid al e p rts a d

memb rs of its te h ic l c mmite s a d IEC Natio al Commite s for a y p rs n l injury, pro erty d ma e or

oth r d ma e of a y n ture wh ts e er, wh th r dire t or in ire t, or for c sts (in lu in le al fe s) a d

e p n e arisin o t of th p blc tio , u e of, or rela c u o , this IEC Pu lc tio or a y oth r IEC

Pu lc tio s

8) Ate tio is drawn to th Normativ refere c s cite in this p blc tio Us of th refere c d p blc tio s is

in is e s ble f or th c re t a plc tio of this p blc tio

9) Ate tio is drawn to th p s ibi ty th t s me of th eleme ts of this IEC Pu lc tio ma b th s bje t of

p te t rig ts IEC s al n t b h ld re p n ible f or id ntifyin a y or al s c p te t rig ts

International Stan ard IEC 8 3 9-5 has b en pre ared by a Joint Workin Group of

s bcommite 6 D: Electromedical eq ipment of IEC tec nical commite 6 : Electrical

eq ipment in medical practice, ISO tec nical commite 210, Qualty management an

cor espon in general asp cts for medical devices an CEN/CENELEC TC3/WG 2, Smal

-b re con ectors

The text of this stan ard is b sed on the fol owin doc ments:

A l st of al p rts in the International Stan ard 8 3 9 series, publ s ed u der the general title

Sma -b re c n e tors for li uids a d g s s in h alth are a p c tio s, can b fou d on the

IEC an ISO we sites

In this stan ard, the f ol owin print typ s are u ed:

– Req irements an def i ition : roman typ

– Informativ material a p arin o tsid of ta le , s c a n te , e ample a d refere c s: in smaler ty e

Normativ te t of ta le is als in a smaler ty e

– TERMS DE INED IN CLA S 3 OF THIS S A D RD OR AS NOT D IN THE IN EX OF DE INED T RMS:

SMAL C PITALS

In this stan ard, the conju ctive “or” is u ed as an “in lu ive or” so a statement is true if an

combination of the con ition is true

The verb l f orms u ed in this standard conf orm to u age des rib d in An ex H of the

ISO/IEC Directives, Part 2 For the purp ses of this stan ard, the au i ary verb:

– “s al ” me n that complan e with a req irement or a test is man atory f or compl an e

with this stan ard;

– “s ould” me n that compl an e with a req irement or a test is recommen ed but is not

man atory for compl an e with this stan ard;

– “may” is u ed to des rib a p rmis ible way to ac ieve compl an e with a req irement or

test

An asteris (*) as the first c aracter of a title or at the b gin in of a p ragra h or ta le title

in icates that there is g idan e or rationale related to that item in An ex A

NOT Th ate tio of Memb r Bo ie a d Natio al Commite s is drawn to th fa t th t e uipme t ma ufa turers

a d te tin org niz tio s ma n e a tra sitio al p rio folowin p blc tio of a n w, ame d d or re is d ISO or

IEC p blc tio in whic to ma e pro u ts in a c rd n e with th n w re uireme ts a d to e uip th ms lv s for

c n u tin n w or re is d te ts It is th re omme d tio of th c mmite s th t th c nte t of this p blc tio b

a o te for impleme tatio n tio aly n t e rler th n 3 y ars fom th d te of p blc tio

The commit e has decided that the contents of this publ cation wi remain u c an ed u ti

the sta i ty date in icated on the IEC we site u der "htp:/we store.iec.c " in the data

related to the sp cifi publ cation At this date, the publ cation wi be

• recon rmed,

• with rawn,

• re laced by a revised edition, or

This International Stan ard was develo ed b cau e of several in idents, with catastro hic

con eq en es, res ltant f rom ina pro riate medication, l q id n tritional f ormula or air b in

administered intravenou ly Man in idents have b en re orted, le din to international

recog ition of the imp rtan e of these is ues, an a ne d has b en identified to develo

sp cif i CON ECTORS f or MEDIC L DEVICE an their A CE SORIE u ed to del ver f l id in other

AP LICATIONS

The International Stan ard 8 3 9 series was develo ed to prevent mis on ection b twe n

SMAL -BORE CON ECTORS u ed in dif f erent AP LICATIONS Part 1 sp cif ies the req irements

neces ary to verif y the desig s an dimen ion of SMAL -BORE CON ECTORS to en ure that:

a) they do not mis on ect with other SMAL -BORE CON ECTORS; an

b) they saf ely an sec rely con ect with their matin half

Part 2 contain the common T S ME HODS to s p ort the p rf orman e req irements f or

SMAL -BORE CONNECTORS The other p rts specify the desig s of SMAL -BORE CONNECTORS f or

the variou AP LIC TIONS

This p rt of International Stan ard 8 3 9 sp cifies the desig an the dimen ion an

drawin s of SMAL -BORE CON ECTORS inten ed for u e in l mb c f f in ation AP LIC TIONS The

informative An ex D throu h An ex G des rib the method by whic this desig has b en

as es ed Other p rts of International Stan ard 8 3 9 in lu e req irements for SMAL -BORE

CONNECTORS u ed in dif ferent AP LIC TION categories

CON ECTORS man factured to the dimen ion set out within this International Stan ard are

theref ore dimen ional y in omp tible with the SMAL -BORE CON ECTORS u ed in other

AP LICATIONS sp cif ied by the stan ard in this series, u les otherwise in icated If f ited to

the relevant MEDIC L DEVICE an A CE SORIE , these CON ECTORS s ould b a le to prevent

air b in del vered intravenou ly CON ECTORS man factured to the dimen ion sp cified in

this stan ard are also NON-INT R ON ECTABLE with an of the other CON ECTORS identif ied in

the International Stan ard 8 3 9 series of stan ard f or SMAL -BORE CON ECTORS, u les

otherwise in icated

SMALL-BORE CONNECTORS FOR LIQUIDS

Part 5: Connectors f or l mb cuff inflation appl cations

1 * Scope

This p rt of International Stan ard 8 3 9 sp cifies dimen ion an req irements f or the

desig an f un tional p rforman e of SMAL -BORE CON ECTORS inten ed to b u ed f or

CONNECTIONS in lmb c f f in ation AP LICATIONS of MEDIC L DEVICE an A CE SORIE Limb

c f f in ation AP LIC TIONS in lu e CON ECTIONS b twe n a sph gmomanometer an its c f f

[3] [7]

1

This p rt of International Stan ard 8 3 9 do s not sp cify req irements f or the

MEDIC L

DEVICE or A CE SORIE that u e these CON ECTORS Su h req irements are given in

p rtic lar International Stan ard for sp cif i MEDICAL DEVICE or A CE SORIE

This p rt of International Stan ard 8 3 9 do s not sp cif y req irements for pres urizin an

de res urizin the retention mec anism (e.g b l o n) u ed to hold in asive MEDIC L DEVICE

in place

NOT 1 MAN FA T RERS are e c ura e to in orp rate th SM L -BO E C N ECTO S s e ifie in this p rt of

Intern tio al Sta d rd 8 3 9 into ME IC L D VICE , me ic l s stems or A CE SO IE , e e if c re tly n t re uire

b th rele a t p rtic lar ME IC L D VICE sta d rd It is e p cte th t wh n th rele a t p rtic lar ME IC L D VICE

sta d rd are re is d, re uireme ts for SM L -BO E C N ECTO S, a s e ifie in this p rt of Intern tio al Sta d rd

8 3 9, wi b in lu e

NOT 2 Th re uireme ts for SM L -BO E C N ECTO S inte d d to b u e with n o atal PATIE T to c n e t a

c f to a s h gmoma ometer are inte d d to b a d d to this sta d rd b a ame dme t or n w e itio

IEC 8 6 1 2-3 [7] d f i e th a era g for n o atal mo e u a e of s h gmoma ometers

NOT 3 Th re uireme ts for SM L -BO E C N ECTO S inte d d to b u e to c n e t a to rniq et to its

in atin e uipme t areinte d d to b a d d to this sta d rd b a ame dme t or n w e itio

NOT 4 ISO 8 3 9- :2 10, 5.8, s e if i s altern tiv meth d of c mpla c with ISO 8 3 9- :2 10, for SM L

-BO E C N ECTO S inte d d f or lmb c f in atio AP LIC TION of ME IC L D VICE or A CE SO IE whic d n t

c mply with this p rt of ISO 8 3 9

2 Normative ref erenc s

The f olowin doc ments, in whole or in p rt, are normatively referen ed in this doc ment an

are in isp n a le f or its a pl cation For dated ref eren es, only the edition cited a pl es For

u dated ref eren es, the latest edition of the referen ed doc ment (in lu in an

amen ments) a pl es

NOT 1 Th wa in whic th s refere c d d c me ts are cite in n rmativ re uireme ts d termin s th

e te t (in wh le or in p rt) to whic th y a ply

NOT 2 Informativ refere c s are lste in th biblo ra h o p g 4

ISO 5 5 -1:2 0 , An e th tic a d re piratory e uipme t – Co ic l c n e tors – P art 1:

ISO 5 5 -2:2 12, An e th tic a d re piratory e uipme t – Co ic l c n e tors – P art 2:

Screw-hre d ed weig tb arin c n e tors

ISO 818 :2 0 , Re piratory tra t h mid ifiers for medic l u e – P artic lar re uireme ts for

re piratory h mid ific tion s stems

ISO 14 71:2 0 , M ed ic l devic s – Ap lc tio of ris ma a eme t to medic l de ic s

ISO 8 3 9-1:2 10, Small-b re c n e tors for li uids a d g s s in h althc re a plc tio s –

P art 1: Ge eral re uireme ts

EN 13 4 -2:2 0 , Re piratory th ra y e uipme t – P art 2: Tu in a d c n e tors

EN 13 4 -2:2 0 :AMD 1:2 0

ASTM D6 8-14, Sta dard test method for te s e pro erties of pla tic

ASTM D7 0-10, Sta dard te t meth ds for flex ural pro ertie of u reinforc d a d reinforc d

pla tic a d ele tric l n ulatin materials

3 Terms and definitions

For the purp ses of this doc ment, the terms an def i ition sp cif ied in ISO 8 3 9-1:2 10,

Note 1 to e try: NO M L U E s o ld n t b c nf us d with IN E D DU E Whie b th in lu e th c n e t of u e a

inte d d b th M N FA T RER, IN E D D U E fo u e o th me ic l p rp s whie NO M L U E in orp rate n t

o ly th me ic l p rp s , b t mainte a c , tra s ort, etc a wel

test on a re resentative sample with the o jective of determinin if the CON ECTOR, as

desig ed an man factured, can me t the req irements of this stan ard

3.6

US R PR FIL

s mmary of the mental, ph sical an demogra hic traits of an inten ed US R group, as wel

as an sp cial c aracteristic , s c as oc up tional s i s, jo req irements an workin

con ition , whic can have a b arin on desig decision

[SOURCE: IEC 6 3 6-1:2 15, def i ition 3.2 ]

4.1 Ge eral re uireme ts f or th l mb c f f inf lation AP LICATION

SMAL -BORE CONNECTORS of MEDIC L DEVICE or A CE SORIE inten ed f or u e in lmb c f f

in ation AP LIC TIONS made in complan e with this stan ard s al comply with ISO 8 3

9-1:2 10 u les otherwise in icated in this stan ard

Becau e the f ol owin CON ECTORS are inadeq ately sp cif ied, SMAL -BORE CONNECTORS f or

u e in l mb c f f in ation AP LIC TIONS s ould not, but may con ect with:

Where the desig of the SMAL -BORE CON ECTOR of this stan ard reles on dimen ion or

f eatures of the MEDIC L DEVICE or A CE SORY to en ure NON-INT R ON ECTABLE

c aracteristic , the NON-INT R ONNECTABLE c aracteristic s al b VERIFIED

Chec complan e by a plyin the tests of ISO 8 3 9-1:2 10, 5.1, an ISO 8 3 9-1:2 10,

An ex B Compl an e also may b s own by a plyin a computer aided desig (CAD)

analy is of the dimen ion of al of the International Stan ard 8 3 9 series SMAL -BORE

CONNECTORS

an the SMAL -BORE CON ECTOR u der test, in conju ction with ph sical testin

of the SMAL -BORE CONNECTOR p r An ex B of ISO 8 3 9-1:2 10, where the CAD analy is

do s not demon trate the NON-INT RCON ECTABLE c aracteristic When neces ary, the

SMAL -BORE CON ECTOR may b in tal ed on the MEDIC L DEVICE or A CE SOR to demon trate

compl an e with the NON-INT R ON ECTABLE c aracteristic test req irements of ISO 8 3

9-1:2 10, An ex B

NOT 1 ME IC L D VICE u in th SM L -BO E C N ECTO S of this sta d rd th t d n t rely o th dime sio s

or fe ture of th ME IC L D VICE or A CE SO Y to e s re NON-IN ER ON ECTABLE c ara teristic are pre ume to

c mply with th NON-IN ER ON ECTABLE c ara teristic te t re uireme ts of this sta d rd

NOT 2 Th s mmary of ME IC L D VICE a d th ir atrib te with C N ECTION within this AP LIC TION is

NOT 5 Th s mmary of a s s me t of th d sig of th s SM L -BO E C N ECTO S a c rdin to

ISO 8 3 9- :2 10, Cla s 7, is c ntain d in informativ An e G

4.2 Materials u e for SMAL -BORE CON ECTORS

In ad ition to the req irements of ISO 8 3 9-1:2 10, Clau e 4, SMAL -BORE CON ECTORS f or

5.1 * Re uireme ts f or a ult or pa diatric PATIENT SMAL -BORE CON ECTORS (S1)

SMAL -BORE CON ECTORS inten ed to b u ed with ad lt or p ediatric PATIENT to con ect a

c f f to a sph gmomanometer s al comply with the relevant dimen ion an toleran es as

given in

– Fig re B.1 an Ta le B.1 f or the male S1 CONNECTOR

– Fig re B.2 an Ta le B.2 f or the f emale S1 CONNECTOR

The male CONNECTOR s al b u ed for the c f f CON ECTOR

NOT An e H d s rib s a o s lete C N ECTO th t h s b e u e to c n e t a c f f a d s h gmoma ometer

a d th t d e n t c mply with this sta d rd

Chec complan e by con rmin the relevant dimen ion an toleran es sp cif ied in An ex B

5.2 Void

6 Perf orma ce requirements

6.1 Air le k ge

The en aged SMAL -BORE CON ECTORS f or lmb c f f in ation AP LIC TIONS s al b evaluated

f or air le kage The le kage f lowrate of p ediatric an ad lt SMAL -BORE CON ECTORS f or l mb

s bjected to an a pl ed pres ure of b twe n 5 kPa (3 5,0 mmHg) an 5 kPa (412,5 mmHg)

f or a hold p riod of 9 s to 10 s MA UFA TU ERS may u e a gre ter a pl ed pres ure or a

lon er hold p riod

Chec compl an e by a plyin the tests of An ex I whi e u in the le kage ref eren e

CONNECTOR sp cif ied in An ex C

6.2 * Re ista c to s paration f rom a ial loa

SMAL -BORE CON ECTORS f or l mb c ff in ation AP LIC TIONS s al b evaluated f or se aration

f rom axial lo d Pa diatric an ad lt CON ECTORS s al not se arate f rom the ref eren e

CONNECTOR over the hold p riod whi e b in s bjected to a dis on ection a pl ed axial force

b twe n 2 N an 3 N for u e in the home he lth are en ironment or for a CONNECTOR on a

dis on ection a pl ed axial force or a lon er hold p riod

Chec compl an e by a plyin the tests of An ex J, whi e u in the se aration from axial lo d

ref eren e CON ECTOR sp cif ied in An ex C

Annex A

(inf ormativ )

Rationale and guidance

A.1 Ge eral guidance

This an ex provides a rationale f or some req irements of IEC 8 3 9-5 an is inten ed for

those who are fami ar with the s bject of IEC 8 3 9-5 but who have not p rticip ted in its

develo ment An u derstan in of the rationale u derlyin these req irements is con idered

to b es ential f or their pro er a pl cation Furthermore, as cl nical practice an tec nolog

c an e, it is b l eved that a rationale wi faci tate an revision of this p rt of International

Stan ard 8 3 9 neces itated by those develo ments

A.2 Rationale for particular cla ses and subclauses

The clau es an s bclau es in this an ex have b en n mb red to cor esp n to the

n mb rin of the clau es an s bclau es of this doc ment to whic they ref er The

n mb rin is, therefore, not con ec tive

In 2 0 , a tas group of the Euro e n stan ard organisation CEN pro osed a strateg to

red ce in idents of ac idental mis on ection of PATIENT thera y tubin by the u e of a series

of NON-INT R ONNECTABLE CONNECTORS, dif f erentiated by desig , f or u e in dif f erent medical

AP LICATIONS The strateg reserves the u e of LUER CON ECTORS solely f or u e in MEDIC L

DEVICE u ed to ac es the vas ular s stem or f or h p dermic s rin es so that they can

ac ieve their inten ed fun tion [4]

4

MA UFA TU ERS an RE PONSIBLE ORGA IZATIONS are en ouraged to re ort their exp rien e

with the SMAL -BORE CON ECTORS sp cif ied in this p rt of International Stan ard 8 3 9 to the

Secretariat of ISO/TC 210, so that it can con ider this f eedb c d rin the revision of the

relevant p rt of this series of International Stan ard

Subcla s 5.1 Re uireme ts for a ult or pa diatric PATIENT SMAL -BORE CONNECTORS

(S1)

The SMAL -BORE CON ECTORS sp cif ied f or u e with ad lt an p ediatric c f f s an

sph gmomanometers are re di y avai a le f rom man sources

5

These CON ECTORS f ul y

me t al the tec nical req irements of this International Stan ard, are widely avai a le

throu hout the world, have b en ac e ted by the marketplace an are fami ar to the US RS

an MA UFA TU ERS al ke These CON ECTORS are NON-INT R ON ECTABLE with al of the

other CONNECTORS sp cif ied in the International Stan ard 8 3 9 series, ex e t as noted

Detai s of the loc in an clos re mec anisms in icated in NOT 2 of Fig re B.2 are not

sp cif ied, as there are several dif ferent, MA UFA TURER-sp cif i , variation in the

marketplace As a res lt, f ul y-detai ed en ine rin drawin s of the loc in an clos re

mec anisms are not avai a le It is p s ible that these u sp cified dimen ion could in re se

the RISK of mis on ection with other CON ECTORS in this series

Subcla s 6.2 Re ista c to s paration f rom a ial loa

The CON ECTORS sp cif ied in this p rt of International Stan ard 8 3 9 for CONNECTORS

inten ed to b u ed f or CONNECTIONS in l mb c ff in ation AP LIC TIONS uti ze pres ures that

are req ired to b held f or a p riod of time when u ed in he lth are faci ties As a res lt,

these CONNECTIONS are exp cted to have a me n to en ure the sec rity of the CON ECTION

(i.e more than ju t a f orce f it l ke the LUER SLI

P

CON ECTOR of ISO 5 4-1) The ex e tion to

this req irement is for home he lth are en ironment sph gmomanometers where the PATIENT

is the US R In this case, the loc in gro ve is not ne ded

Clau e C.2 Sphy moma ometer a d c f f S1 ref ere c CON ECTORS

The sp cified ref eren e

CONNECTOR

S are the

CON ECTOR desig s original y u ed by

MA UFA TU ERS for S1 in this AP LIC TION As s c , it is a pro riate that al other S1

CONNECTORS are desig ed an tested to intero erate with them

Cla s I 2 Te t condition

Cla s J.2 Te t condition

Eac T S ME HOD in lu es precon itionin an en ironmental test req irements

Temp rature an h midity precon itionin req irements from ISO 5 4-1 an ISO 5 4-2 also

have b en ad ed in the T S ME HOD

S f or h gros o ic materials, as these materials are

k own to a sorb moisture from s r ou din gases an l q id , whic can alter ph sical

c aracteristic , dimen ion an p rf orman e of CON ECTORS

The temp rature ran e sp cif ied f or testin is identical to that sp cif ied in ISO 5 4-1 an

ISO 5 4-2

Annex B

(normative)

SMALL-BORE CONNECTORS f or the l mb cuf f inf lation APPLICATION

Fig res B.1 an B.2 i u trate a male c f f S1 SMAL -BORE CONNECTOR an a female

sph gmomanometer S1 SMAL -BORE CONNECTOR resp ctively Ta les B.1 an B.2 in icate the

resp ctive dimen ion of these

Table B.1 – Male c f f S1 SMAL -BORE CON ECTOR dime sions

Di me sion i n mm unl es ot herwise i nd icat ed

Øf In id diameter at th tip of th male b y n t 2,4 0 2,6 5 2,9 0

ga

Øj5 a

Ta le B.2 c ntain th dime sio s for this fig re.

Th s aln s ra e of ØH of th female C N ECTO n e n t c mply with 4.2 (e.g b ela tomeric)

Th o ter diameter of th female C N ECTO (ØW) n e n t b ro n

NOT 1 Th s aln s rf ac is re re e te b dime sio Øh of th male C N ECTO th t mate to th s aln

s ra e of ØS5 of th female C N ECTO

NOT 2 Th d tais of th lo kin me h nism u in th gro v of th male C N ECTO are M N FA T

RER-s e ific

Figure B.2 – F male sphy moma ometer S1 SMAL -BORE CON ECTOR

Ta le B.1 a d Ta le B.2 c ntain th dime sio s for this fig re

Figure B.3 – Sphy moma ometer a d c f f SMAL -BORE CON ECTOR (S1) a s mbly

Table B.2 – Female sphy moma ometer S1 SMAL -BORE CONNECTOR dime sions

Di me sion i n mm unl es ot herw e i nd icat ed

Female S1 SM L -B RE C N ECTO

Dime sion

Annex C

(normative)

Ref erence CONNECTORS

C.1 Ge eral requireme ts f or refere ce CONNECTORS

The ref eren e CONNECTORS f or l mb c f f in ation AP LIC TION s al b man f actured f rom

cor osion- esistant RIGID MAT RIALS

C.2 * Sphy momanometer and c f f S1 refere ce CONNECTORS

The referen e

CON ECTORS

f or sph gmomanometer an c ff S1 f or le kage, se aration f rom

axial lo d an NON-INT R ONNECTABLE c aracteristic s al b the stan ard commercialy

avai a le CON ECTORS

6

Annex D

(inf ormativ )

Assessment of MEDICAL DEVICES and their at ributes

with CONNECTIONS within this APPLICATION

The req irements f or CON ECTIONS f or sph gmomanometers in l mb c f f in ation are wel

req irements for an exten ed p riod These req irements are fou d in ISO 810 0-1 an

IEC 8 6 1-2-3

Annex E

(inf ormativ )

Summary of the usabi ity requirements f or SMAL -BORE CONNECTORS

f or l mb cuf f inf lation APPLICATIONS

The US R PROFILE is a s mmary of the mental, ph sical an demogra hic traits of an inten ed

US R p pulation, as wel as an sp cial c aracteristic that can have a b arin on desig

decision , s c as oc up tional s i s an jo req irements

Sph gmomanometers (MEDIC L DEVICE inten ed to take or monitor non-in asive blo d

pres ure) in lu e ne rly al PATIENT p pulation typ s an age ran es as non-in asive

estimation of blo d pres ure is one of the most common PATIENT p rameters u ed in

he lth are As a res lt, the US R of a sph gmomanometer in lu es ne rly every cl nician in a

he lth are faci ty or ambulan e as wel as most ad lts in the home he lth are en ironment

This prof ile do s not cover the u e of sph gmomanometers with ne natal PATIENT as

CONNECTORS f or this PATIENT-p pulation are not yet in orp rated into this stan ard

US RS of SMAL -BORE CON ECTORS f or l mb c f f in ation AP LICATION u e are comprised of the

PATIENT themselves, fami y or frien s helpin the PATIENT an al levels of he lth are

providers f rom volu te rs to primary care providers an sp cial sts US RS are exp cted to

p rform an inten ed action in NORMAL US

US RS in lu e:

a) PATIENT , as the p rson u dergoin a medical, s rgical or dental PROCED RE who are

also exp cted to p rf orm an inten ed action

b) clnical US RS, s c as:

• ph sician , ph sician’s as istants, al levels;

• n rses, at al levels;

• home-care providers, visitin n rses, PATIENT an relatives; an

• emergen y medical tec nician

The US R PROFILE is s mmarized in Ta le E.1

US RS c n h v a dis bi ty (e.g.imp ire

sig t, in bi ty to ma ip late smal

sph gmomanometers u e the dis on ection of the c f f as the emergen y me n to def late

the c f f

E.3 Use e vironme ts and scenarios

Sph gmomanometers are uti zed in virtualy every en ironment where blo d pres ure

s re nin or monitorin is ne ded This can in lu e, but is not l mited to, commercial set in s

(pharmacies), home u e, he lth are cl nic , emergen y an f ield medicine an hospital

set in s In al setin s there is the p tential ne d f or b th sin le (s re nin ) an contin ou

blo d pres ure monitorin In these en ironments, the ne d f or a sec re CON ECTION an

a i ty to dis on ect is simiar

A sph gmomanometer is u ed whenever blo d pres ure s re nin or monitorin is

neces ary Situation ran e from simple blo d pres ure s re nin to emergen y u e where

multiple sph gmomanometers are b in u ed d rin stres f ul events as wel as the diag ostic

determination of blo d pres ure L cation in lu e hospitals, s rgery s ites, PATIENT ro ms,

la our & del very, inten ive care u its, doctors’ of f ices, p in clnic , pharmacies, f ield

hospitals, tran p rt s stems, infusion cl nic , homes, as isted care u its an emergen y

medical services

The folowin temp rature en ironments are exp cted f or lmb c f f inf lation SMAL -BORE

CONNECTORS:

a) ambient temp rature, – 2 °C to + 5 °C (f or f ield u e in emergen y medical services [5]

an outdo r u e by home he lth are PATIENT [4]); an

b) b d temp rature, to 4 °C

E.4 Ge eric US R needs

The generic US R ne d f or l mb c f f in ation CON ECTIONS in lu e the f olowin :

a) The CON ECTORS of this AP LIC TION s ould b e s to manipulate but they do not req ire

the same force as the LUER CONNECTOR to con ect or dis on ect

b) The CONNECTORS of this AP LIC TION are not p rmited to con ect to other CONNECTORS in

the en ironment of u e

c) The CON ECTORS of this AP LIC TION are not p rmited to le k u der NORMAL US to p rmit

ac urate blo d pres ure determination to oc ur

d) Sec rity of CON ECTION s ould b evident by mec anical or cog itive me n (vis al,

tacti e an /or au itory con rmation of a CONNECTION)

e) The US R ne d to b a le to dis on ect the CON ECTION when pres urized to p rmit the

rele se of air pres ure from the c f f an rele se of the PATIENT in sph gmomanometer

f ai ure

f ) The CON ECTORS f or this AP LIC TION ne d to b made f rom biocomp tible materials

s ita le for s in contact

g) Decontamination is ne ded Sph gmomanometers an their c f fs are typical y reu a le

an therefore it is neces ary that they can b cle ned an , when a pro riate, disinf ected

or steri zed

An ex F contain the detai ed req irements for CON ECTORS of this AP LIC TION

Annex F

(inf ormativ )

Summary of SMAL -BORE CONNECTOR design requirements

f or l mb cuff inflation APPLICATIONS

Ta le F.1 is a s mmary of the desig req irements for the ad lt or p ediatric PATIENT

sph gmomanometer an c f f S1 CON ECTOR

Table F.1 – Adult or pa diatric PATIENT sph gmoma ometer

a d c f f S1 CON ECTOR-spe ific de ign re uireme ts (1 of 4)

E tern ly, how is C N ECTO to be distinguis able

from L ER C N ECTO ? (d s rib )

Table F.2 – Neonatal sphy moma ometer a d c f f CON ECTOR-spe ific

Annex G

(inf ormativ )

Summary of assessment of the design of the CONNECTORS

f or l mb cuff inflation APPLICATION

The S1 SMAL -BORE CON ECTORS sp cif ied in An ex B of this International Stan ard, whic

are inten ed f or u e with ad lt or p ediatric PATIENT to con ect a c f f to a

sph gmomanometer or its hose, have b en in widespre d u e f or this purp se f or more than

2 ye rs US RS have f ou d these CONNECTORS to b clnical y ac e ta le an more

imp rtantly, they are NON-INT RCON ECTABLE with the 6 % female LUER CON ECTORS u ed in

intravas ular an h p dermic AP LIC TIONS

NOT Th s mmary of th a s s me t for SM L -BO E C N ECTO S inte d d to b u e with n o atal PATIE T

to c n e t a c f to a s h gmoma ometer or to c n e t a to rniq et to its inflatin e uipme t is inte d d to b

a d d to this a n x b a ame dme t or n w e itio th t intro u e th s C N ECTO S

G.2 Summary of the e gine ring analysis of the design

A thre -dimen ional computer aided desig (CAD) en ine rin analy is has b en p rformed

u in computational analy is an 3D sold model con tru ts of al toleran es an material

con ition for al CON ECTORS re resented by this series of International stan ard The

SMAL -BORE CONNECTORS sp cif ied in this stan ard have b en s own by en ine rin analy is

to b NON-INT R ON ECTABLE with the other sp cif ied CON ECTORS of this series with the

ex e tion of the fol owin Ta le G.1 s mmarises the p tential mis on ection

A tec nical re ort is plan ed to des rib the PROCE S f or the CAD en ine rin analy is more

Testin was p rformed ac ordin to the T S ME HOD of ISO 8 3 9-1:2 10, An ex B

The test demon trated that the CONNECTORS are NON-INT R ON ECTABLE

G.3 Summary of the design VERIFICATION

Becau e of the lon an s c es ful history of widespre d cl nical u e, the commit e

con lu ed that it was u neces ary to evaluate further these CON ECTOR s stems ac ordin to

PROCE S S an PROCEDU E of ISO 8 3 9-1:2 10, Clau e 7

S1 CON ECTORS of two con g ration were tested:

Con lu ion:

The test res lts in icate the S1 desig is compl ant with the p rf orman e req irements

sp cif ied in Clau e 6 u in the T S ME HODS def i ed in ISO 8 3 9-2 :2 15

G.4 Summary of the design v l dation

Becau e of the lon an s c es ful history of widespre d cl nical u e, the commit e

con lu ed that it was u neces ary to f urther evaluate f urther these CON ECTOR s stems

ac ordin to

PROCE S S an PROCED RE of ISO 8 3 9-1:2 10, 7.3.4

G.5 Summary of the design re iew

The S1 CON ECTORS ref lect the sp cif i desig s that have b en in u e f or decades

Becau e of the lon an s c es ful history of widespre d cl nical u e, the commit e

con lu ed that it was u neces ary to evaluate further the S1 CON ECTORS ac ordin to

PROCE S S an PROCED RE of ISO 8 3 9-1:2 10, Clau e 7.4 The S1 CON ECTORS sp cif ied

in An ex B have b en s own to b NON-INT R ON ECTABLE with the other sp cif ied

CONNECTORS of this series

The commite reviewed the as es ment of the desig of the S1 CONNECTORS b sed on the

res lts re orted in this An ex G

In s mmary, the desig review con lu es there is sig if i ant o jective en ine rin , tec nical

an cl nical eviden e s p ortin the S1 CON ECTOR f or the inten ed AP LIC TION

Annex H

(inf ormativ )

Obsolete l mb cuff inflation CONNECTOR

The CON ECTORS des rib d in this an ex have b en u ed f or decades for non-automated

sph gmomanometers These CON ECTORS have not b en in lu ed in this stan ard for f uture

u e b cau e they are k own to fai the

NON-INT R ON ECTABLE tests of ISO 8 3 9-1:2 10,

An ex B

However, there are a very large n mb r of sph gmomanometers in c r ent cl nical u e that

uti ze this CON ECTOR s stem Becau e these sph gmomanometers have an exp cted

service lf e of several decades, they wi req ire a p rmanent ada tor to con ert f rom this

o solete CON ECTOR to the S1 CON ECTORS sp cified in this stan ard

The historical dimen ion of the o solete CONNECTOR are des rib d in Fig re H.1, Ta le H.1

an Ta le H.2 of this an ex to as ist in the develo ment of p rmanent ada tors for the retrof it

con ersion of existin in tal ed sph gmomanometers to the new CON ECTORS

Ta le H.1 a d Ta le H.2 c ntainth dime sio s for this f i ure.

Figure H.1 – Obsolete sphy moma ometer a d c f f SMAL -BO E CONNECTOR

Table H.1 – Obsolete male sphy moma ometer

a d c f f SMAL -BORE CON ECTOR dime sions

Di me sion i n mm unl es ot herwise i nd icat ed

Fin (U F) of th Unif i d Thre d Sta d rd Major diameter [9]

Table H.2 – Obsolete f emale sphy moma ometer

a d c f f SMAL -BORE CON ECTOR dime sions

Di me sion i n mm unl es ot herwise i nd icat ed

Annex I

(inf ormativ )

Air leakage by pressure decay TEST METHOD

I.1 Principle

The CON ECTOR u der test is sec rely as embled to an a pro riate referen e CONNECTOR

The air is introd ced into the CON ECTION an pres urized to the sp cif ied pres ure The

le kage f lowrate is then me s red

I.2 * Test conditions

I 2.1 Te t s mple pre on itionin

Prior to testin , precon ition the CON ECTOR u der test at 2 °C ± 5 °C an 5 % ± 10 %

relative h midity f or not les than 2 h Precon itionin ne d not b p rf ormed for a

CONNECTOR made f rom non-h gros o ic materials

I 2.2 Environme tal te t conditions

Perf orm tests at a temp rature within the ran e of 15 °C to 3 °C an at a relative h midity

The fol owin items s al b uti zed

a) The male or f emale CON ECTOR u der test

b) The a pro riate referen e CONNECTOR, as sp cif ied in An ex C f or the le kage T S

ME HOD, to b as embled to the CONNECTOR u der test

c) A me n to contain an pres urize air to the sp cif ied test pres ure Rigid fi tures an

a p ratu materials (s c as metal) s ould b u ed to avoid inac urate test res lts

d) A device ca a le of me s rin an displayin the ela sed time with an ac urac of ± 1 s

e) A device ca a le of me s rin an displayin the a pl ed pres ure with a minimum

a) As emble the CONNECTOR u der test to the a pro riate male or f emale referen e

CONNECTOR, b th CON ECTORS b in dry Ful y en age the loc in mec anism, if present

g) Calc late the le kage rate, L on the b sis of Eq ation I 1.

tp

v

tpsp

sp = the lower l mit of the sp cif ied test pres ure in Pa,

tp = the actual test pres ure at the start of the test in Pa,

v = the volume from the valve to the test sp cimen in cm

a) As emble the CONNECTOR u der test to the a pro riate male or f emale referen e

CONNECTOR, b th CON ECTORS b in dry Ful y en age the loc in mec anism, if present

b) Se l the outlet b re of the CON ECTOR un er test

c) Submerge the en aged CONNECTORS in the water b th an place water f il ed grad ated

c ln er a ove

d) Ap ly the air at the a pl ed pres ure sp cif ied for the sp cif i CONNECTOR u der test to

the as embly throu h the b re an close the valve

e) Start the timin device an wait 10 min

f ) Me s re the volume of air in the grad ated c ln er

g) Divide the volume by 10 , (i.e calc late the le kage volume p r min te)

h) Con rm that the le kage volume do s not ex e d 0,10 cm

3

/min

I.5 Test report

Pre are a test re ort that:

– sp cif ies testin was p rf ormed ac ordin to IEC 8 3 9-5:2 16, An ex I Air le kage by

pres ure decay T S ME HOD;

– identif ies the CONNECTORS u der test;

– identif ies the n mb r of CON ECTORS tested;

– identif ies the a pl ed pres ure u ed;

– identif ies the ac e tan e criterion;

– dis loses the me s red test pres ure;

Annex J

(inf ormativ )

Resistance to separation from axial load TEST METHOD

J.1 Principle

The sec rity of the CONNECTION to an axial pul is determined by a plyin an axial se aration

f orce b twe n the as embled CON ECTOR u der test an the a pro riate ref eren e

CONNECTOR Where loc in mec anisms are present, they are en aged The CONNECTION is

exp cted to b maintained

J.2 * Test conditions

J.2.1 Te t s mple pre on itioning

Prior to testin , precon ition the CON ECTOR u der test at 2 °C ± 5 °C an 5 % ± 10 %

relative h midity f or not les than 2 h Precon itionin ne d not b p rf ormed for a

CONNECTOR made f rom non-h gros o ic materials

J.2.2 Environme tal te t conditions

Perf orm tests at a temp rature within the ran e of 15 °C to 3 °C an at a relative h midity

The fol owin items s al b uti zed:

a) the male or female CONNECTOR u der test;

b) the a pro riate ref eren e CON ECTOR, as sp cif ied in An ex C for the resistan e to

se aration from axial lo d T S ME HOD, to b as embled to the CON ECTOR u der test;

c) a me n of me s rin the sp cif ied axial force;

d) a device ca a le of me s rin an displayin the ela sed time with an ac urac of ± 1 s

J.4 PROCEDURE

Chec complan e with the fol owin test

a) As emble the CONNECTOR u der test to the a pro riate male or f emale referen e

CONNECTOR, b th CON ECTORS b in dry Ful y en age the loc in mec anism, if present

b) Ap ly an axial force in a direction away from the test f i ture at a rate of a proximately

2,5 N/s u ti the sp cified axial f orce is re c ed Hold the axial f orce f or a p riod b twe n

10 s an 15 s

c) Con rm by vis al in p ction that CON ECTORS remain en aged

J.5 Test report

Pre are a test re ort that:

– sp cif ies testin was p rf ormed ac ordin to IEC 8 3 9-5:2 16, An ex J, “Resistan e to

se aration from axial lo d T S ME HOD”;

Annex K

(inf ormativ )

Ref erence to the essential principles

This doc ment has b en pre ared to s p ort the es ential prin iples of safety an

p rf orman e of SMAL -BORE CON ECTORS inten ed to be u ed for CONNECTIONS in

intravas ular or h p dermic

AP LIC TIONS of MEDIC L DEVICE an related A CE SORIE

ac ordin to ISO/TR 1614 :2 0 This doc ment is inten ed to b ac e ta le for conf ormity

Table K.1 – Cor e pon e c betwe n this doc me t

a d the e s ntial principle (1 of 2)

Es e tial prin iple of