Tiêu Chuẩn Iso 05360-2016.Pdf

© ISO 2016 Anaesthetic vaporizers — Agent specific filling systems Évaporateurs d’anesthésie — Systèmes de remplissage spécifiques à l’agent INTERNATIONAL STANDARD ISO 5360 Fourth edition 2016 02 15 R[.]

A naesthetic vaporizers — A g

Év p rateurs d’a e sth sie — S stème s de r mplissage spécifiques à

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

A ll rig hts r eserved Unles otherw ise spe ified, nopar of this p blc tion ma y be r epr od c d or utilz d otherw ise in an form

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

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms and definitions 1

4 Bot le 2

5 Bot le c olar 3

6 Bot le adaptor 6

7 Fi le rec eptacle 10

8 Fi lng rate 12

9 Le kag e 14

10 Overfilng pr otectio 14

11 Colour c oding 14

12 Usabiity 14

13 Clnical evaluation 14

14 Infor mation provided by the manufactur er 15

14.1 Mar king 1

14.2 L bel ng 1

14.3 Ins ructions for use 1

A nne x A (informative)Rec ommendatio s o mater ials 17

A nne x B (informative)T ypes of ag ent-specific fi lng systems 18

A nne x C (normative) Determinatio of total le kag e into atmosphere of ana sthetic ag ent dur ing fi lng 19

Biblog raphy 21

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 1 1, An es thetic a d r s pirator y eq ipment,

Subcommitt ee SC1, B reathin at achments a d a aes thetic machines

This fourth edition canc ls an r plac s the third edition (ISO 5 6 :2 1 ), of w hich it cons itut es a

minor r vision with the folowing chang es:

— Figur 5 has be n t echnicaly r vised;

— minor edit orial modificationsha e be n incorp rat ed int o the t ext

A naesthetic vapor izers — A g ent-specific fil ing systems

This Int ernational Stan ard spe if ies r q ir ment , inclu ing dimensions, for ag ent-spe if ic fil ng

sy st ems for ag ent-spe ific anaes hetic v p riz rs

This Int ernational Stan ard does not spe ify cons ruction mat erials

NOTE 1 F or recommen ations on materials, se An e A

Be a use of the uniq e pro e ties of des lurane, dimensions for this ag ent ha e not be n spe ified in

this Int ernational Stan ard

NOTE 2 Designs of con ection sy st ems, which only permit eng g ment of the a ent-specif ic b t le adaptor to

the b t le when the b t le colar is in place, are encoura ed

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 0 , G eometric al Produc t S ec ific atio s (GPS) — G eometric al tole a c in — Tole a c es o frm,

orientatio , loc atio a d run-o t

3 Terms and definitions

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

3.1

ag ent-specific

ha ing b th a pr sc ibed conf iguration an pr sc ibed dimensions, w hich ar spe if ic for a pr sc ibed

lq id anaes hetic ag ent

3.2

ag ent-specific fi lng sy stem

fu ctional sy st em of a ent-s pec ific (3.1)coded con e tions betwe n an anaes hetic b t le an an a

ent-s pec ific (3.1) a aes thetic v p ri ze (3.3), consis ing of, for ex mple, a thr aded b t le neck (3.7) with

col ar, b ttle c on ec tor (3.6), male ada tor (3 9), and fi e r c eptacle (3.8)

Note 1t o entry: Diferent ty es of a ent-specif ic f iling systems are shown in An e B

3.3

ana sthetic vaporizer

devic designed t o faci tat e the chang e of an anaes hetic ag ent from a lq id t o a v p ur

Each b t le shal ha e the folowing:

a) name of the anaes hetic ag ent with w hich it is int en ed t o be used marked on it ;

b) eithe a b t le colar complying with Clause 5 an a thr aded ne k complying with Figur 1 an

Ta le1, or a pe manently at ached b t le ada t or complying with 6.2

Dimensions in milimetr es

Flatnes an perpen icularity toler ances in ac or dance w ith ISO 1 0

NOTE The dimensions shown form part of this Int ernational Stan ard Other fe tures are for ilustrative

p rposes only S e Ta le 1

Figure 1 — Two examples of thre ded necks of bot les for ana sthetic ag ents

Table 1 — Dimensions of thre ded necks of bot les for ana sthetic ag ents

2

− D

3)

should be req ired toavoid problems with the fit in of an bot le c n e tor

5 Bot le c ol ar

5.1 Bottle colars shal comply with the config uration an dimensions shown in Fig ur e 2 and angle, θ,

spe ified in Ta le 2 for theanaes hetic ag ent with which it is intended to be used

5.2 T e p sition of the b tle colar relati ve to the screw thread of the b tle shal be as shown in Figure 3

5.3 The b tle colar shal be attached to the b ttle and shal be r otata le b han

Dimensions in milimetr es

R

,

52,9+,2

3,9+,2

0

θa

Ma y vary to suit b ttle

Figure 2— Co figuratio of ag ent-specific bot le colar

Table 2 — Dimensio s and colour of ag ent-specific bot le colar and connector

Ana sthetic

a ent

θa

± ° 30′

Sp cified

colourb

E ample of colour samples

Federal

Stan ard

595

c lour[5]

BS 5 5

c lour[3]

Pantone

c lour[7]

S

0191 02

c lour[9]

Munsel

c lour[6]cDIN 616 -2

c lour[4]

If a c lour is used on a vaporiz r, botle, or pa kage label to fa i tate c r e t identific tion, it is impor ant hat only the

c lour for the ap ropriate ana s hetic agent be used

N/A me ns not avaiable

Dimensions in milimetr es

Cle rance to suit b ttle

Figure 3 — Alternative positio s of ag ent-specific bot le col ar

6 Bot le adaptor

6.1 If the b t le ada tor is not pe manently atached to the b ttle or the v poriz r ( e A nnex B),

it shal inclu e an ag ent-spe ific b tle con e tor complying w ith the config uration an dimensions

spe ified in Fig ur e 6 for the anaes hetic ag ent w ith which it is inten ed to be used T e b ttle con e tor

shal be desig ned so that the coding slot in the b ttle con e tor engag e with the b ttle colar befor e a

tight con e tion is o tained

If an ag ent-spe if ic male ada t or is used, it shal comply with the dimensions spe ified in Figur 4 or

Figur 5 for the anaes hetic ag ent with w hich it is int ended t o be used

6.2 If the b tle ada tor is pe manently atached to the b ttle an an ag ent-spe ific male ada tor is

used, the ag ent-spe ific male ada tor shal comply with the dimensions spe ified in Fig ur e 4 or Fig ur e 5

for the anaes hetic ag ent with which it is inten ed to be used

6.3 If the b ttle ada tor is a pe manent p rt of the v p riz r, it shal inclu e an ag ent-spe ific b tle

con e tor complying with the config uration an dimensions spe ified in Fig ur e 6 for the anaes hetic

ag ent with which it isinten ed to be used T e b ttle con e tor shal be desig ned so that the coding slot

in the b tle con e tor engag e with the b tle colar before a tig ht con e tion is o tained

6.4 Botle ada tor threadsshal be desig ned so that they

a) ensur an eng g ement of at leas 0,7 thr ad turns on a thr aded ne k [se Cla use 4 b)] of an

anaes hetic bot le, and

b) withs an , without visible damag e, a tight ening t orq e of (3 ± 0,3) N⋅m, w hen f itt ed t o an

a pro riat e b t le

NOTE T e intention of these req irements is to ren er the b t le adapt or u likely to b ac idental y

displaced from the b t le d ring f iling

6.5 If the b ttle ada tor is pe manen y atached to the b ttle ( e A nnex B) an an ag ent-spe ific

male ada tor complying with the config uration show n in Fig ur e 4 or Fig ur e 5 is used, means shal be

provided for seal ng the lq id and air/ a our p s ag es on the ada tor when it is not inse ted into the

fi e r ec ptacle

6.6 The b ttle ada tor shal not br eak when dr op ed from a height of 1 m on to a har d surfac

Dimensions in milimetr es

4 0

21

3 se ling face

NOTE 1 S e also Ta le 3

NOTE 2 Port identif ication ap lies t o f il ing proced re only

Figure 4 — C nfiguration and dimensions of ag ent-specific male adaptor for use with

enflurane, metho yflurane, an halothane

Table 3 — Detai s of male adaptor for use with enflurane, meth xyflurane and halothane

Anaes hetic ag ent

t

0,

Anaes hetic ag ent

t

0,

2

-9,1

01

NOTE S e Ta le 4 an Figure 4

Figure 5 — C nfiguration and dimensions of ag ent-specific male adaptor for use with

isoflurane an sev fluraneTable 3 (c ontin ed)

Table 4 — Detai s of male adaptor for use with isoflurane and sev flurane

Anaes hetic ag ent Slot position

-0,63

0,6

2a

0,6

1 ,3 0

b

d

A

BA

Ma y vary to suit b ttle

Figure 6 — C nfiguratio and dimensio s of ag ent-specific bot le connector

7 Fi ler rec eptacle

7.1 The fi e r ec ptacle of the v p riz r shal

a) comply with the con guration and dimensions shown in Figur 7 or Figur 8 for the anaes hetic

ag ent with w hich it is int en ed t o be used, an the design shal only pe mit the inse tion of the

ag ent-spe ific male ada t or complying with 6.1 or 6.2 int o the front fac of the file r c ptacle as

i lus rat ed in Figur 7 or Figur 8, or

b) comply with the conf iguration an dimensions of the b t le conne t or shown in Figur 6 an

angle, θ, spe if ied in Ta le2 for the anaes hetic ag ent with w hich it is int en ed t o be used

Dimensions in milimetr es

NOTE 2 Port identif ication ap lies t o f il ing proced re only

Figure 7 — C nfiguration and dimensions of ag ent-specific fi le receptacles for use with

enflurane, metho yflurane an halothane

Table 5 — Detai s of fi ler receptacles for use with enflurane, metho yflurane an halothane

Anaes hetic ag ent

7.2 If the fi e r ec ptacle is of the type spe ified in 7.1 a), means for tig htening the male ada tor

agains the r ec ptacle seal( ) when the ada tor is inse ted into the fi le r ec ptacle shal be pr ovided

7.3 The fi e rec ptacle shal be pr ovided with a means of sealng the lq id an air/ a our p s ag es

in the r ec ptacle whie the b ttleada tor is not inse ted

8 Fi l ng rate

When t est ed ac ording t o the man factur r’ s ins ructions, the mean f il ng rat e shal ex ce d 2 ml/s

Dimensions in milimetr es

NOTE 2 S e Figure 7 for al other details

Figure 8 — C nfiguration and dimensions of ag ent-specific fi le receptacles for use with

isoflurane an sev flurane

Table 6 — Detai s of file receptacles for use with isoflurane an sev flurane

Anaes hetic ag ent Pin inse t ed in fac C an adjac nt t o

When measur d in ac ordanc with Annex C, the mean leakag e of lq id or v poriz d anaes hetic ag ent

int o the atmosphe e shal not ex ce d 0,5 ml

It is r co niz d that d ring discon e tion of the male ada t or from the v p riz r an the b t le ada t or

from the b t le, smal amount of anaes hetic ag ent esca e t o the environment This should be not ed in

the use ins ruction man al

Means should be pro ided t o ensur that as lt le anaes hetic ag ent as p s ible esca es from the male

ada t or t o the environment w hen the ada t or is affix ed t o the b t le d ring st orag e

NOTE A ttention is drawn t o substances which are car ino enic, muta enic, or to ic to reprod ction

10 Ov rfi l ng protection

When f iled in ac ordanc with the man factur r’ s ins ructions, it shal not be p s ible t o o e f il the

v p riz r such that

a) it pe formanc is afe t ed, an

b) fluid level is no long er visible

11 Colour c oding

The b t le colar an the b t le con e t or shal incorp rat e colour coding using the colour spe if ied b

name in Ta le 2 for the anaes hetic ag ent int en ed

Ifthe file r c ptacle is colour-coded, the colour shal comply with the colour spe ified b name in Ta le 2

A cl nical ev luation shal be pe formed and document ed in therisk manag ement f ile

Che k compl anc b inspe tion ofthe risk manag ement f ile

14 Information provided by the manufactur er

14.1 Mar king

Ag ent-spe if ic fil ing sy st ems or b t le colars or b t leada t orssup led in ivid aly shal be marked

with the fol owing:

a) man factur r’s name an / r trademark an w he e the man factur r does not ha e an ad r s

within thelocale, the name an ad r s of an authoriz d r pr sentative within the locale;

b) bat ch code or the se ial n mbe ;

c) name of the anaes hetic ag ent with w hich it is int en ed t o be used

The use of the g ene ic names of anaes hetic ag ent ac ording t o Ta le 2 is r commen ed

14.2 Label ing

14.2.1 A g ent-spe ific fi ing sys ems or comp nents sup l ed in ividualy shal pr ovide the folowing

information on the devic itself, on the u it p ck, or on a leaflet ac omp nying the devic :

a) name an ad r s of the man factur r/sup le an w he e the man factur r does not ha e an

addr s within the locale, the name an ad r s of an authoriz d r pr sentativewithin the locale;

b) information ne es ary t o identify the devic or the cont ent of the packag e;

c) anaes hetic ag ent with w hich the devic shal be used;

d) if a pro riat e, an in ication of the time l mit for using the devic safely, ex r s ed as year/month;

e) in ication if the devic isfor single use only;

NOT Man facturer’ s att ention is drawn to consistent use of in ication for single-use devices

f) any r lev nt p rticular st orag e an / r han l ng ins ructions

If phthalat es ar incorp rat ed in p rt of the devic coming dir ctly or in ir ctly int o contact with the

p tient, the devic shal be la eled ac ordingly ( e EN 1 9 6)

14.2.2 T e b ttle ada tor shal ha ve a leaflet enclosed with the devic g iving the folowing warning :

“Caution: ag ent-spe ific fi ing can ot be as ur ed when b ttles without colars ar e used”

14.3 Instructions for use

Ins ructions for use of ag ent-spe if ic f il ng sy st ems or comp nent the eof shal be pro ided b the

v p riz r man factur r or sup le an shal inclu e the folowing:

a) detai s r fe r d t o in 14.2.1 with the ex ception of those in it ems c) and d);