Tiêu Chuẩn Iso 06009-2016.Pdf

© ISO 2016 Hypodermic needles for single use — Colour coding for identification Aiguilles hypodermiques non réutilisables — Code de couleurs pour l’identification INTERNATIONAL STANDARD ISO 6009 Fourt[.]

Hypodermic needles for single use —

Colour c oding for identification

Aiguille s h p de mique s n n ré tilisable s — Code de co leurs p ur

l’identification

Fourth edition

2 16-0 -0

Refer ence n mb r

ISO 60 9:2 16(E)

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

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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

the r eq eser

ISO c pyrig ht ofic

C de Blan on et 8 • C 4 1

CH-1 14 Vernier, Geneva, Sw itzerlan

Tel + 12 7 9 011

Fax 412 7 9 0 4

c pyrig ht@iso.or g

www.iso.or g

F reword i v

Introduction v

1 Sc ope 1

2 Terms and definitions 1

3 Colour c ode 1

A nne x A (informative)Referenc e c olo r samples 3

Biblog raphy 6

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

This fourth edition canc ls an r plac s the third edition (ISO 6 0 :1 9 ), which has be n te h icaly

r vised It also incorp rates a Te h ical C r ig end m ISO 6 09:1 9 / or.1:20 8

The main chang es t o the pr vious edition of ISO 6 0 introd c d b this r vision ar the folowing:

a) bro dening of the rang e of ne dles t o designat ed ne dle siz down t o 0,1 mm;

b) r view of the use of ins rumentaly det ermined colour zones (chromaticity and luminanc

in ex) as used in pr vious editions t o spe ify o aq e colours an has de ided that ins rumental

measur ment is not practica le;

c) r vision of Annex A;

d) deletion of An ex B

The int ention of this Int ernational Stan ard is t o spe ify colours t o ena le ra id visual identif ication

of the out er diamet er of single-use hy ode mic ne dles The pr senc of colour coding on a ne dle or

p ckag e does not a solve the use of the r sp nsibi ty t o che k the marked siz of the ne dle This

r vision def ines, in ad ition, colours for mor f ine ne dles t o folow the tr n in the market

The colours used t o code ne dles ma be a pled in eithe o aq e or transp r nt form, and the colour

code is eq aly a pl ca le t o r gular waled, thin-waled, extra-thin and ultra-thin waled ne dles The

nominal out er diamet ers of ne dles lst ed in this Int ernational Stan ard for w hich colours ar given ar

those spe ified in ISO 9 2

This Int ernational Standard es a l shes a colour code but does not pe ify that ne dles ar t o be

colour-coded or t o w hat p rtion of the ne dle an / r p cka ing the colour is t o be a pled Such r q ir ment

ma be given in the r lev nt prod ct s an ards such as ISO 7 64

The measur ment of the colour zone of an o aq e colour, espe ialy of an it em of the siz an sha e

of the h b of a ne dle, is a complex proc d r r q iring a p ratus an ex e tise that is t o be fou d in

r latively few la orat ories an t es houses It ma the efor be inconvenient, diff icult or imp s ible for

a man factur r or pur hase routinely t o as es complanc of a prod ct with colour zone v lues Such

diff iculties ar comp u ded in the case of transluc nt colours, w hich ar being used inc easingly b

ne dle man factur rs t o alow air bub les inside the h b t o be se n an elminat ed befor inje tion

As a conseq enc , the colours in this Int ernational Stan ard ar only r fe enc d b a colour r fe enc

sy st em (RAL) or b Pant one Mat ching Sy st em ac epting that his inevita ly introd c s a c rtain amou t

of subje tivity in the as es ment of complanc

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

Hypodermic needles for sing le use — Colour c oding for

identification

This lnt ernational Stan ard es a lshes a colour code for the identification of single-use hy ode mic

ne dles of designat ed metric siz in the rang e of 0,1 mm (34 Ga ug e) t o 3,4 mm (1 Gaug e) It a ples

t o r gular-waled, thin-waled, extra-thin-wal ed an ultra-thin waled ne dles, an t o o aq e an

transluc nt colours

This Int ernational Stan ard isnot a plca le t o pen-ne dles

2 Terms and definitions

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

2.1

designated metric size

out er diamet er designation ofthe tubing as def ined in Ta le 1

Note 1t o entry: It is e pres ed in mil imetres

2.2

g ug e

leg cy siz designation

Note 1 t o entry: A particular g ug e size cor espon s t o a designated metric size def ining limits for outer

diameter

The colour shal in icat e the nominal out er diamet er of the tube of the ne dle an shal be as given in

Ta le 1

An ex A contains c rtain guidanc t o commonly a pled colour r fe enc sy st ems for o aq e mat erials

Table 1 — C lour co e

Designat ed metric siz

mm

Designat ed metric siz

mm

Table 1 (c ontin ed)

A nne x A

Table A.1 — Reference colo r samples

Designat ed metric siz

mm

Pant one

r fe enc

2 07

2 0

2 0

1 75

1 7

16

9 04

9 0

9 17

Black 3

Black 4

Black 6

60 0

60 1

60 2

348

349

3 0

9 0

9 1

9 16

1 – 60

1 – 60

1 – 1 3

1 1

1 2

1 2

1 2

1 7

1 9

3 17

3 1

3 3

1797

71

1 7

5 0

5 0

5 2

3 2

3 2

3 9

7047

70 5

704

427

42

42

8 16

8 17

8 1

75 7

75 8

75 9

2 07

2 0

2 0

1 75

1 7

16

40 1

40 5

Not availa le

6 6

6 7

6 8

Designat ed metric siz

mm

Pant one

r fe enc

5 0

5 1

5 0

2 4

541

540

9 04

9 0

9 17

Black 3

Black 4

Black 6

60 0

60 1

60 2

348

349

3 0

1 1

1 2

1 2

1 2

1 7

1 9

1 14

1 1

1 0

4545

45 5

45 7

Not availa le

3 1

3 14

1 6

1 7

70

Not availa le

40 6

40 8

2 9

240

2415

9 0

9 1

9 16

1 – 60

1 – 60

1 – 1 3

70 0

70 1

70 1

754

7545

754

Not availa le

60 9

60 1

3 1

34

345

40 1

40 5

Not availa le

6 6

6 7

6 8 Table A.1 (c ontin ed)

Designat ed metric siz

mm

Pant one

r fe enc

5 1

5 1

5 24

2 5 C 1

2 2 C 1

7454 C 1

Not availa le

60 8

Not availa le

36

368

369

60 7

60 8

60 5

5 4

5 3

560

RAL C lour p lett e:

RAL C AS IC Colour palett e K5, E ition 2 1 used for def inition in ISO 60 9

Two other colour palet es availa le from RAL were not aken into consideration:

RAL E F C Colour palet e E2, E ition 2 07

RAL DESIG Colour palet e D2, E ition 2 1

Man factur r:

RAL g mein ützig GmbH

Sie burg r Straße 3

5 757 S n t A ugustin

German

Telep one (within German ): 0 2 41– 2 5 16 – 3

Telep one (international): +49 (0) 2 41 – 2 5 16 – 60

F ax: + 49 (0) 2 41 – 2 5 16 - 16

E-Mail RAL-Colour @RAL-gGmbH.de

Pant one colour p lett e:

PANTO E COLOR BRIDGE u co t ed

PANTO E COLOR BRIDGE co t ed

Man factur r:

Pant one L C

5 0 Commer e Boulevard

Carlstadt, New Jer ey

07072-3 9 USA

Tel 2 1-9 5-5 0

F ax: 2 1-8 6-0 42

E-Mail corp j@pantone.com

We : www.pant one.com

Table A.1 (c ontin ed)

Bibl og raphy

[1] ISO 7 64, Ste ie hypode mic ne dles fr s in le use — R eq ir ments a d tes t meth ds

[2] ISO 9 2 , Stainles s s te l ne dle tu in fr the ma uac tur o medic al dev ic es — R eq ir ment a d

tes t meth ds

[3] ISO/TR 1 244, Guida c e o tra s ition pe iods fr s ta dards develo ed b ISO/TC 84 — Dev ic es fr

admini s tration o medic in l produc ts a d c athete s

ICS  01.070; 11.040.25

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