Medical devices — Symbols to be used with medical device labels, … · 2018. 12. 1. · 15223-1. Second edition. 2012-07-01. Medical devices — Symbols to be used with medical

Reference numberISO 15223-1:2012(E)

© ISO 2012

INTERNATIONAL STANDARD

ISO15223-1

Second edition2012-07-01

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied —

Part 1: General requirements

Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux —

Partie 1: Exigences générales

Licensed to [email protected] ISO Store order #: OP-65992/Downloaded: 2015-04-30 Single user licence only, copying and networking prohibited.

ISO 15223-1:2012(E)

COPYRIGHT PROTECTED DOCUMENT © ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester.

ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org

Published in Switzerland

ii © ISO 2012 – All rights reserved


ISO 15223-1:2012(E)

© ISO 2012 – All rights reserved iii

Contents Page

Foreword ............................................................................................................................................................ iv

Introduction ......................................................................................................................................................... v

1 Scope ...................................................................................................................................................... 1

2 Normative references ............................................................................................................................ 1

3 Terms and definitions ........................................................................................................................... 1

4 General requirements ........................................................................................................................... 2 4.1 Proposal of symbols for adoption ....................................................................................................... 2 4.2 Requirements for usage ....................................................................................................................... 2 4.3 Other symbols ....................................................................................................................................... 3

5 Symbols .................................................................................................................................................. 3 5.1 Manufacture ........................................................................................................................................... 4 5.2 Sterility.................................................................................................................................................... 6 5.3 Storage ................................................................................................................................................... 9 5.4 Safe use ................................................................................................................................................ 11 5.5 IVD-specific .......................................................................................................................................... 12 5.6 Transfusion/infusion ........................................................................................................................... 14 5.7 Other ..................................................................................................................................................... 16

Annex A (informative) Examples ..................................................................................................................... 17

Annex B (informative) Use of general prohibition symbol and negation symbol ...................................... 21

Bibliography ...................................................................................................................................................... 22


ISO 15223-1:2012(E)

iv © ISO 2012 – All rights reserved

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.

This second edition cancels and replaces the first edition (ISO 15223-1:2007) and EN 980:2008, which have been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.

ISO 15223 consists of the following parts, under the general title Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied:


Part 2: Symbol development, selection and validation

NOTE Future symbols intended to appear in this part of ISO 15223 are to be validated in accordance with ISO 15223-2.


ISO 15223-1:2012(E)

© ISO 2012 – All rights reserved v

Introduction

This part of ISO 15223 addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device.

Many countries require that their own language be used to display textual information with medical devices. At the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can cause problems in relation to translation, design and logistics when multiple languages are included on a single label or piece of documentation. For example, users of medical devices labelled in a number of different languages can experience confusion and delay in locating the appropriate language.

This part of ISO 15223 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined descriptions.

While compiling symbols to be included in this part of ISO 15223, ISO/TC 210 recognized the need for systematic methodology for the selection, development and validation of symbols proposed for adoption. This is the subject of ISO 15223-2.

This part of ISO 15223 is primarily intended to be used by manufacturers of medical devices who market identical products in countries where there are different language requirements for medical device labelling. It can also be of assistance to:

distributors of medical devices or other representatives of manufacturers;

healthcare providers responsible for training as well as those being trained;

those responsible for post-market vigilance;

healthcare regulatory authorities, testing organizations, certification bodies and other organizations which are responsible for implementing regulations affecting medical devices and which have responsibility for post-market surveillance; and

consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.

This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved. This part of ISO 15223 represents a significant advance in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a single set of global symbols for use with medical devices.



INTERNATIONAL STANDARD ISO 15223-1:2012(E)

© ISO 2012 – All rights reserved 1

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied —


1 Scope

This part of ISO 15223 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of ISO 15223.

This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7000, Graphical symbols for use on equipment — Index and synopsis

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 2: Symbol development, selection and validation

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.

3.1 characteristic information information that represents the property or properties of a symbol

3.2 description normative text which defines the purpose, application and use of the symbol

NOTE Adapted from IEC 80416-1:2008, definition 3.2.


ISO 15223-1:2012(E)

2 © ISO 2012 – All rights reserved

3.3 label written, printed or graphic information provided upon the medical device itself

NOTE Adapted from GHTF/SG1/N43:2005.

3.4 labelling information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device or any of its containers or wrappers

NOTE 1 This information relates to the identification, technical description and use of the medical device, but excludes shipping documents.

NOTE 2 Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.

3.5 symbol used in medical device labelling graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

NOTE The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters.

3.6 title unique name by which a graphical symbol is identified and spoken of

NOTE Adapted from IEC 80416-1:2008, definition 3.9.

4 General requirements

4.1 Proposal of symbols for adoption

Symbols proposed for adoption in this part of ISO 15223 shall be validated in accordance with ISO 15223-2.

Any symbol proposed for adoption in this part of ISO 15223 shall be applicable to a range of medical devices and have global or regional applicability.

4.2 Requirements for usage

When risk management shows it to be appropriate for symbols to be used to convey information essential for proper use on the medical device, its packaging or in associated documentation, the symbols given in Table 1 may be used.

Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000, especially with respect to relative dimensions, including relative line thickness, orientation and the absence or presence of filled or shaded areas.

NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains the complete set of graphical symbols included in ISO 7000 and IEC 60417. In that database, each graphical symbol is identified by a reference number and contains a title (in English and French), a graphical representation in GIF and vectorized PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy retrieval of graphical symbols. Information on how to subscribe in order to access this database is available through the ISO Store, the IEC Web Store or by contacting your local national standards body.


ISO 15223-1:2012(E)


As part of risk management, the manufacturer should determine the appropriate size for the symbol to be legible for its intended function.

NOTE 2 This part of ISO 15223 does not specify colours or minimum size for the symbols in Table 1, nor does it specify the relative size of symbols and that of indicated information.

It is important that symbols be used properly. Guidance on appropriate use of the general prohibition symbol and the negation symbol is given in Annex B.

Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use of the symbol does not introduce an unacceptable risk.

NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.

Symbols may be used without accompanying text. Where regulations require accompanying text, the title of the symbol given in this part of ISO 15223 should be considered sufficient. All dates and times presented in association with symbols shall use the conventions set out in ISO 8601.

4.3 Other symbols

Other standards specify additional symbols that are applicable to particular kinds or groups of medical devices or to particular situations. Examples of sources for such symbols are identified in the Bibliography. This listing is not exhaustive.

5 Symbols

When appropriate, information essential for proper use shall be indicated on the medical device, its packaging, or in the associated documentation by using the corresponding symbols given in Table 1.

A manufacturer may use any appropriate symbol regardless of category.

NOTE Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.


ISO

152

23-1

:201

2(E

)

Tab

le 1

— S

y mb

ols

to

co

nve

y in

form

atio

n e

ssen

tial

fo

r p

rop

er u

se

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.1

Man

ufa

ctu

re

5.1.

1

Man

ufac

ture

r In

dica

tes

the

med

ical

dev

ice

man

ufac

ture

r, a

s de

fined

in E

U

Dir

ectiv

es

90/3

85/E

EC

, 93

/42/

EE

C a

nd

98/7

9/E

C.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

the

nam

e an

d ad

dres

s of

the

m

anuf

actu

rer

(i.e

. the

pe

rson

pla

cing

the

med

ical

de

vice

on

the

mar

ket)

, ad

jace

nt to

the

sym

bol.

Acc

ordi

ng to

EU

Dire

ctiv

e 98

/79/

EC

, the

ad

dres

s is

no

t req

uire

d w

ith t

he

sym

bol o

n an

IVD

med

ical

de

vice

's im

med

iate

co

ntai

ner,

as

spec

ified

in

ISO

181

13-2

, IS

O 1

8113

-3, I

SO

181

13-4

an

d IS

O 1

811

3-5

, exc

ept

wh

en th

e im

med

iate

co

ntai

ner

is a

lso

the

oute

r co

ntai

ner.

NO

TE

1

Thi

s sy

mbo

l is

used

to

indi

cate

info

rmat

ion

that

is r

equi

red

in E

urop

eb .

NO

TE

2

The

ful

l def

initi

on

of “

man

ufac

ture

r” is

giv

en in

E

U D

irect

ives

90/

385/

EE

C,

93/4

2/E

EC

and

98/

79/E

C.

NO

TE

3

Gui

danc

e on

the

requ

irem

ents

for

EU

Dire

ctiv

es

90/3

85/E

EC

and

93/

42/E

EC

is

give

n in

EN

104

1.

NO

TE

4

The

dat

e of

m

anuf

actu

re,

as w

ell a

s th

e na

me

and

addr

ess

of th

e m

anuf

actu

rer,

can

be

com

bine

d in

one

sym

bol.

NO

TE

5

The

rel

ativ

e si

ze

of th

e sy

mbo

l and

the

siz

e of

th

e na

me

and

addr

ess

are

not

spec

ified

.

3082

5.1.

2

Aut

horiz

ed

repr

esen

tativ

e in

the

Eur

opea

n C

omm

unity

Indi

cate

s th

e A

utho

rized

re

pres

enta

tive

in t

he

Eur

opea

n C

omm

unity

.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

the

nam

e an

d ad

dres

s of

the

au

thor

ized

rep

rese

ntat

ive

in th

e E

urop

ean

Com

mun

ity, a

dja

cent

to

the

sym

bol.

The

add

ress

is n

ot

requ

ired

with

the

sym

bol

on a

n in

vitr

o di

agno

stic

m

edic

al d

evic

e's

imm

edia

te c

onta

iner

, as

spec

ified

in IS

O 1

8113

-2,

ISO

181

13-3

, IS

O 1

8113

-4

and

ISO

18

113-

5, e

xcep

t w

hen

the

imm

edia

te

cont

aine

r is

als

o th

e ou

ter

cont

aine

r.

NO

TE

1

Thi

s sy

mbo

l is

used

to

indi

cate

info

rmat

ion

that

is r

equi

red

in t

he

Eur

opea

n C

omm

unity

.

NO

TE

2

Gui

danc

e on

the

requ

irem

ents

for

EU

Dire

ctiv

es

90/3

85/E

EC

and

93/

42/E

EC

is

give

n in

EN

104

1.

NO

TE

3

The

rel

ativ

e si

ze

of th

e sy

mbo

l and

the

siz

e of

th

e na

me

and

addr

ess

are

not

spec

ified

.

4©

ISO

201

2 –

All

right

s re

serv

ed


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.1.

3

Dat

e of

m

anuf

actu

re

Indi

cate

s th

e da

te

wh

en th

e m

edic

al

de

vice

was

m

anuf

actu

red.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

a da

te to

in

dica

te th

e da

te o

f m

anuf

actu

re.

Thi

s sh

all b

e ex

pres

sed

as in

IS

O 8

601

as fo

ur d

igits

for

the

yea

r an

d, w

here

app

ropr

iate

, tw

o d

igits

for

the

mon

th

and

two

digi

ts fo

r th

e da

y.

The

dat

e sh

all b

e lo

cate

d ad

jace

nt to

the

sym

bol.

NO

TE

1

The

rel

ativ

e si

ze

of t

he s

ymbo

l an

d th

e si

ze o

f th

e da

te a

re n

ot s

peci

fied.

NO

TE

2

Thi

s sy

mbo

l ca

n be

fill

ed o

r un

fille

d. I

f fil

led,

the

da

te o

f m

anuf

actu

re a

s w

ell a

s th

e na

me

and

addr

ess

of t

he

man

ufac

ture

can

be

com

bine

d in

one

sym

bol.

In

Eur

opeb

:

the

date

cou

ld b

e a

ye

ar,

yea

r an

d m

onth

, or

ye

ar, m

onth

and

da

y, a

s re

quire

d in

the

rele

vant

EU

Dire

ctiv

e;

this

sym

bol m

ay

be

used

to id

entif

y th

e m

onth

and

yea

r of

m

anuf

actu

re fo

r ac

tive

impl

anta

ble

med

ical

de

vice

s, o

r th

e ye

ar o

f m

anuf

actu

re fo

r ac

tive

med

ical

dev

ices

wh

ere

no u

se b

y da

te is

gi

ven,

as

requ

ired

by

the

appr

opria

te E

U

Dire

ctiv

e.

2497

5.1.

4

Use

-by

dat

e

Indi

cate

s th

e da

te

afte

r w

hich

the

med

ical

dev

ice

is

not t

o be

use

d.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

a da

te to

in

dica

te th

at th

e m

edic

al

devi

ce s

houl

d no

t be

used

af

ter

the

end

of t

he y

ear,

m

onth

or

day

show

n.

The

dat

e sh

all b

e

expr

esse

d as

in I

SO

860

1 as

four

dig

its fo

r th

e ye

ar

and,

whe

re a

ppro

pria

te,

two

dig

its fo

r th

e m

onth

an

d tw

o di

gits

for

the

day.

The

dat

e sh

all b

e lo

cate

d ad

jace

nt to

the

sym

bol.

NO

TE

1

For

exa

mpl

e,

June

200

2 is

exp

ress

ed a

s 20

02-0

6.

NO

TE

2

The

rel

ativ

e si

ze

of th

e sy

mbo

l and

the

siz

e of

th

e da

te a

re n

ot s

peci

fied.

NO

TE

3

Syn

onym

for

“u

se-b

y da

te”

is “

use

by”.

NO

TE

4

For

som

e m

edic

al d

evic

es (

e.g.

IVD

s),

this

dat

e is

onl

y va

lid w

hen

the

med

ical

dev

ice

is u

nope

ned.

In

Eur

opeb

:

the

date

cou

ld b

e a

ye

ar,

yea

r an

d m

onth

, or

ye

ar, m

onth

and

da

y, a

s re

quire

d b

y th

e re

leva

nt E

U D

irect

ive;

this

sym

bol c

an b

e us

ed to

iden

tify

the

time

limit

for

impl

antin

g an

act

ive

impl

anta

ble

med

ical

dev

ice

safe

ly

as r

equi

red

by

EU

D

irect

ive

90/3

85/E

EC

.

2607

5.1.

5

Bat

ch c

ode

Indi

cate

s th

e m

anuf

actu

rer's

ba

tch

code

so

that

th

e ba

tch

or lo

t can

be

iden

tifie

d.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

the

man

ufac

ture

r's b

atch

cod

e.

The

bat

ch c

ode

shal

l be

adja

cent

to th

e sy

mbo

l.

NO

TE

1

The

rel

ativ

e si

ze

of th

e sy

mbo

l and

the

siz

e of

th

e ba

tch

code

are

not

sp

ecifi

ed.

NO

TE

2

Syn

onym

s fo

r “b

atch

cod

e” a

re “

lot

num

ber”

an

d “b

atch

num

ber”

.

2492

© IS

O 2

012

– A

ll rig

hts

rese

rved

5


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.1.

6

Cat

alog

ue

num

ber

Indi

cate

s th

e m

anuf

actu

rer's

ca

talo

gue

num

ber

so th

at th

e m

edic

al

devi

ce c

an b

e id

entif

ied.

The

man

ufac

ture

r's

cata

logu

e nu

mbe

r sh

all b

e ad

jace

nt to

the

sym

bol.

NO

TE

1

The

rel

ativ

e si

ze

of th

e sy

mbo

l and

the

siz

e of

th

e ca

talo

gue

num

ber

are

not

spec

ified

.

NO

TE

2

Syn

onym

s fo

r “c

atal

ogue

num

ber”

are

“r

efer

ence

num

ber”

and

“r

eord

er n

umbe

r”.

In E

urop

eb, t

he

man

ufac

ture

r's c

atal

ogue

nu

mbe

r sh

all b

e pl

aced

afte

r or

bel

ow

the

sym

bol a

nd

adja

cent

to it

. Thi

s sy

mbo

l m

ay

curr

ently

be

show

n w

ithou

t th

e en

clos

ure;

ho

wev

er, i

t is

inte

nded

that

th

is o

ptio

n be

with

dra

wn

in a

fu

ture

edi

tion

of t

his

part

of

ISO

152

23.

24

93

5.1.

7

Ser

ial n

umbe

r In

dica

tes

the

man

ufac

ture

r's

seria

l num

ber

so

that

a s

peci

fic

med

ical

dev

ice

can

be id

entif

ied.

Thi

s sy

mb

ol s

hall

be

acco

mpa

nied

by

the

man

ufac

ture

r's s

eria

l nu

mbe

r. T

he s

eria

l num

ber

shal

l be

adja

cent

to th

e sy

mbo

l.

NO

TE

T

he r

elat

ive

size

of

the

sym

bol a

nd t

he s

ize

of

the

seria

l num

ber

are

not

spec

ified

.

In E

urop

eb, t

he

man

ufac

ture

r's s

eria

l nu

mbe

r sh

all b

e pl

aced

afte

r or

bel

ow

the

sym

bol a

nd

adja

cent

to it

. Thi

s sy

mbo

l m

ay

curr

ently

be

show

n w

ithou

t th

e en

clos

ure;

ho

wev

er, i

t is

inte

nded

that

th

is o

ptio

n be

with

dra

wn

in a

fu

ture

edi

tion

of t

his

part

of

ISO

152

23.

24

98

5.2

Ste

rili

ty

5.2.

1

Ste

rile

Indi

cate

s a

med

ical

de

vice

that

has

be

en s

ubje

cted

to a

st

erili

zatio

n pr

oces

s.

N

OT

E

Use

of t

his

sym

bol p

recl

udes

the

use

of

sym

bols

5.2

.2 t

o 5.

2.5.

In E

urop

eb, t

his

sym

bol i

s re

stric

ted

to u

se o

n te

rmin

ally

ste

riliz

ed

me

dic

al

devi

ces

(4.1

of

EN

556

-1:2

001

app

lies,

in

clud

ing

its a

ssoc

iate

d no

te).

24

99

6©

ISO

201

2 –

All

right

s re

serv

ed


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.2.

2

Ste

riliz

ed u

sing

as

eptic

pr

oces

sing

te

chni

ques

Indi

cate

s a

med

ical

de

vice

that

has

be

en m

anuf

actu

red

usin

g ac

cept

ed

asep

tic te

chni

ques

.

N

OT

E 1

A

sept

ic

tech

niqu

es c

an in

clud

e fil

trat

ion.

NO

TE

2

Use

of t

his

sym

bol p

recl

udes

the

use

of

sym

bol 5

.2.1

.

2500

5.2.

3

Ste

riliz

ed u

sing

et

hyl

ene

oxi

de

Indi

cate

s a

med

ical

de

vice

that

has

be

en s

teril

ized

usi

ng

eth

ylen

e o

xide

.

N

OT

E

Use

of t

his

sym

bol p

recl

udes

the

use

of

sym

bol 5

.2.1

.

In E

urop

eb, t

his

sym

bol i

s re

stric

ted

to u

se o

n te

rmin

ally

ste

riliz

ed

me

dic

al

devi

ces

(4.1

of

EN

556

-1:2

001

app

lies,

in

clud

ing

its a

ssoc

iate

d no

te).

25

01

5.2.

4

Ste

riliz

ed u

sing

irr

adia

tion

Indi

cate

s a

med

ical

de

vice

that

has

be

en s

teril

ized

usi

ng

irrad

iatio

n.

N

OT

E 1

T

his

sym

bol c

an

be u

sed

to in

dica

te th

at th

e pr

oduc

t ha

s be

en s

ubje

cted

to

irrad

iatio

n pr

oces

ses.

NO

TE

2

Use

of t

his

sym

bol p

recl

udes

the

use

of

sym

bol 5

.2.1

.

In E

urop

eb, t

his

sym

bol i

s re

stric

ted

to u

se o

n te

rmin

ally

ste

riliz

ed

me

dic

al

devi

ces

(4.1

of

EN

556

-1:2

001

app

lies,

in

clud

ing

its a

ssoc

iate

d no

te).

25

02

5.2.

5

Ste

riliz

ed u

sing

st

eam

or

dry

heat

Indi

cate

s a

med

ical

de

vice

that

has

be

en s

teril

ized

usi

ng

stea

m o

r dr

y he

at.

N

OT

E

Use

of t

his

sym

bol p

recl

udes

the

use

of

sym

bol 5

.2.1

.

In E

urop

eb, t

his

sym

bol i

s re

stric

ted

to u

se o

n te

rmin

ally

ste

riliz

ed

me

dic

al

devi

ces

(4.1

of

EN

556

-1:2

001

app

lies,

in

clud

ing

its a

ssoc

iate

d no

te).

25

03

© IS

O 2

012

– A

ll rig

hts

rese

rved

7


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.2.

6

Do

not

rest

eril

ize

Indi

cate

s a

med

ical

de

vice

that

is n

ot to

be

res

teril

ized

.

2608

5.2.

7

Non

-ste

rile

Indi

cate

s a

med

ical

de

vice

that

has

not

be

en s

ubje

cted

to a

st

erili

zatio

n pr

oces

s.

Thi

s sy

mb

ol s

houl

d on

ly b

e us

ed to

dis

tingu

ish

betw

een

iden

tical

or

sim

ilar

med

ical

de

vice

s so

ld in

bot

h st

erile

an

d no

n-st

erile

con

ditio

ns.

26

09

5.2.

8

Do

not u

se if

pa

ckag

e is

da

mag

ed

Indi

cate

s a

med

ical

de

vice

that

sho

uld

not b

e us

ed if

the

pa

ckag

e ha

s be

en

dam

aged

or

open

ed.

N

OT

E

Thi

s sy

mbo

l may

al

so m

ean

"Do

not u

se if

the

pr

oduc

t st

erile

bar

rier

syst

em

or it

s pa

ckag

ing

is

com

prom

ised

”.

In

Eur

opeb

, thi

s sy

mbo

l sha

ll be

exp

lain

ed in

the

in

form

atio

n su

pplie

d b

y th

e m

anuf

actu

rer.

2606

5.2.

9

Ste

rile

fluid

pa

th

Indi

cate

s th

e pr

esen

ce o

f a s

teril

e flu

id p

ath

with

in t

he

med

ica

l dev

ice

in

case

s w

hen

othe

r pa

rts

of th

e m

edic

al

devi

ce, i

nclu

ding

the

exte

rior,

mig

ht n

ot

be s

uppl

ied

ster

ile.

The

met

hod

of s

teril

izat

ion

shal

l be

indi

cate

d in

the

empt

y bo

x, a

s ap

prop

riate

.

The

par

t of t

he m

edic

al

devi

ce t

hat

is s

teril

e sh

all

be id

entif

ied

in th

e in

form

atio

n su

pplie

d b

y th

e m

anuf

actu

rer.

In E

urop

eb, t

his

sym

bol s

hall

be e

xpla

ined

in t

he

info

rmat

ion

supp

lied

by

the

man

ufac

ture

r.

3084

8©

ISO

201

2 –

All

right

s re

serv

ed


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.3

Sto

rag

e

5.3.

1

Fra

gile

, han

dle

with

car

e

Indi

cate

s a

med

ical

de

vice

that

can

be

brok

en o

r da

mag

ed

if no

t han

dled

ca

refu

lly.

0621

5.3.

2

Kee

p a

wa

y fr

om s

unlig

ht

Indi

cate

s a

med

ical

de

vice

that

nee

ds

prot

ectio

n fr

om li

ght

sour

ces.

N

OT

E

Thi

s sy

mbo

l can

al

so m

ean

“Kee

p aw

ay

from

he

at”,

as

refe

renc

ed in

IS

O 7

000:

1989

.

0624

5.3.

3

Pro

tect

from

he

at a

nd

radi

oact

ive

sou

rces

Indi

cate

s a

med

ical

de

vice

that

nee

ds

prot

ectio

n fr

om h

eat

and

radi

oact

ive

sour

ces.

N

OT

E

Thi

s sy

mbo

l can

al

so m

ean

“Kee

p aw

ay

from

su

nlig

ht a

nd r

adio

activ

e so

urce

s”.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

0615

5.3.

4

Kee

p dr

y In

dica

tes

a m

edic

al

devi

ce th

at n

eeds

to

be p

rote

cted

fro

m

moi

stur

e.

N

OT

E

Thi

s sy

mbo

l can

al

so m

ean

“Kee

p aw

ay

from

ra

in”

as r

efer

ence

d in

IS

O 7

000.

0626

© IS

O 2

012

– A

ll rig

hts

rese

rved

9


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.3.

5

Lo

wer

lim

it o

f te

mpe

ratu

re

Indi

cate

s th

e lo

wer

lim

it of

tem

pera

ture

to

whi

ch th

e m

edic

al

devi

ce c

an b

e sa

fely

ex

pose

d.

Th

e lo

wer

lim

it o

f te

mpe

ratu

re s

hall

be

indi

cate

d ad

jace

nt to

the

low

er

horiz

onta

l lin

e.

05

34

5.3.

6

Upp

er li

mit

of

tem

pera

ture

In

dica

tes

the

uppe

r lim

it of

tem

pera

ture

to

whi

ch th

e m

edic

al

devi

ce c

an b

e sa

fely

ex

pose

d.

The

upp

er

limit

of

tem

pera

ture

sha

ll be

in

dica

ted

adja

cent

to th

e up

per

horiz

onta

l lin

e.

05

33

5.3.

7

Tem

pera

ture

lim

it In

dica

tes

the

tem

pera

ture

lim

its to

w

hich

the

me

dica

l de

vice

can

be

safe

ly

expo

sed.

The

upp

er

and

low

er

limits

of

tem

pera

ture

sha

ll be

in

dica

ted

adja

cent

to th

e up

per

and

low

er h

oriz

onta

l lin

es.

06

32

5.3.

8

Hum

idity

lim

itatio

n In

dica

tes

the

ran

ge

of h

umid

ity to

wh

ich

the

med

ical

dev

ice

can

be s

afel

y ex

pose

d.

The

hum

idity

lim

itatio

n sh

all b

e in

dica

ted

adja

cent

to

the

uppe

r an

d lo

we

r ho

rizon

tal l

ines

.

In E

urop

e b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2620

10

© IS

O 2

012

– A

ll rig

hts

rese

rved


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.3.

9

Atm

osph

eric

pr

essu

re

limita

tion

Indi

cate

s th

e ra

nge

of

atm

osph

eric

pr

essu

re to

whi

ch

the

med

ical

dev

ice

can

be s

afel

y ex

pose

d.

The

atm

osph

eric

pre

ssur

e lim

itatio

ns s

hall

be

indi

cate

d ad

jace

nt to

the

uppe

r an

d lo

wer

hor

izon

tal

line

s.

In E

urop

e b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2621

5.4

Saf

e u

se

5.4.

1

Bio

logi

cal r

isks

In

dica

tes

that

ther

e ar

e po

tent

ial

bio

log

ica

l ris

ks

asso

ciat

ed w

ith t

he

med

ical

dev

ice.

N

OT

E

Thi

s sy

mbo

l is

not t

o be

con

fuse

d w

ith t

he

“Bio

haza

rd”

sign

inte

nded

to

be u

sed

in th

e w

orkp

lace

.

See

ISO

701

0.

0659

5.4.

2

Do

not r

e-u

se

Indi

cate

s a

med

ical

de

vice

that

is

inte

nded

for

one

use,

or

for

use

on

a si

ngle

pat

ient

dur

ing

a si

ngle

pro

cedu

re.

N

OT

E

Syn

onym

s fo

r “D

o no

t re

-use

” ar

e “s

ingl

e us

e” a

nd “

use

only

onc

e”.

1051

5.4.

3

Con

sult

inst

ruct

ions

for

use

Indi

cate

s th

e ne

ed

for

the

user

to

cons

ult t

he

inst

ruct

ions

for

use.

N

OT

E 1

S

ynon

ym f

or

“Con

sult

inst

ruct

ions

for

use”

is

“Con

sult

oper

atin

g in

stru

ctio

ns”.

NO

TE

2

Con

side

r th

e di

ffere

nce

betw

een

the

desc

riptio

n of

thi

s sy

mbo

l and

th

at o

f sym

bol 5

.4.4

.

1641

© IS

O 2

012

– A

ll rig

hts

rese

rved

11


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.4.

4

Cau

tion

Indi

cate

s th

e ne

ed

for

the

user

to

cons

ult t

he

inst

ruct

ions

for

use

for

impo

rtan

t ca

utio

nary

in

form

atio

n su

ch a

s w

arn

ings

and

pr

ecau

tions

that

ca

nnot

, for

a v

arie

ty

of r

easo

ns, b

e pr

esen

ted

on th

e

med

ical

dev

ice

itsel

f.

The

sym

bol v

aria

nt

ISO

700

0-0

434B

(“

Cau

tion

”) m

ay

be u

sed.

NO

TE

1

Con

side

r th

e di

ffere

nce

betw

een

the

desc

riptio

n of

thi

s sy

mbo

l and

th

at o

f sym

bol 5

.4.3

.

NO

TE

2

Thi

s sy

mbo

l is

esse

ntia

lly a

cau

tiona

ry

sym

bol a

nd s

houl

d be

use

d to

hi

ghlig

ht th

e fa

ct th

at th

ere

are

spec

ific

war

ning

s or

pr

ecau

tions

ass

ocia

ted

with

th

e m

edic

al d

evic

e, w

hich

are

no

t oth

erw

ise

foun

d on

the

labe

l.

Thi

s sy

mb

ol is

not

to b

e co

nfus

ed w

ith th

e “C

autio

n”

sign

inte

nded

to b

e us

ed in

th

e w

orkp

lace

.

04

34A

5.4.

5

Con

tain

s or

pr

esen

ce o

f na

tura

l rub

ber

la

tex

Indi

cate

s th

e pr

esen

ce o

f nat

ura

l ru

bber

or

dry

natu

ral

rubb

er la

tex

as a

m

ater

ial o

f co

nstr

uctio

n w

ithin

th

e m

edic

al d

evic

e or

the

pack

agin

g of

a

med

ical

dev

ice.

N

OT

E

Thi

s sy

mbo

l is

inte

nded

to w

arn

thos

e pe

ople

w

ho m

ay

have

alle

rgic

re

actio

ns to

cer

tain

pro

tein

s in

la

tex.

Thi

s sy

mb

ol s

houl

d no

t be

used

for

med

ical

dev

ices

co

ntai

ning

“sy

nth

etic

ru

bber

”.

In E

urop

eb, t

his

sym

bol s

hall

be e

xpla

ined

in t

he

info

rmat

ion

supp

lied

by

the

man

ufac

ture

r.

N/A

5.5

IVD

-sp

ecif

ic

5.5.

1

In v

itro

diag

nost

ic

me

dic

al d

evi

ce

Indi

cate

s a

med

ical

de

vice

that

is

inte

nded

to b

e us

ed

as a

n in

vitr

o di

agno

stic

med

ical

de

vice

.

Thi

s sy

mb

ol s

houl

d on

ly b

e us

ed to

iden

tify

in v

itro

diag

nost

ic m

edic

al d

evic

es

and

not t

o sp

ecify

that

the

med

ical

dev

ice

is fo

r “in

vitr

o us

e”.

In E

urop

eb, t

his

sym

bol i

s on

ly u

sed

to id

entif

y in

vitr

o di

agno

stic

med

ical

dev

ices

as

def

ined

in E

U

Dire

ctiv

e 98

/79/

EC

.

12

© IS

O 2

012

– A

ll rig

hts

rese

rved


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.5.

2

Con

trol

In

dica

tes

a co

ntro

l m

ater

ial t

hat i

s in

tend

ed to

ver

ify

the

perf

orm

ance

ch

arac

teris

tics

of

anot

her

med

ical

de

vice

.

N

OT

E

For

neg

ativ

e co

ntro

ls,

use

sym

bol 5

.5.3

and

fo

r po

sitiv

e co

ntro

ls,

use

sym

bol 5

.5.4

.

2494

5.5.

3

Neg

ativ

e co

ntro

l In

dica

tes

a co

ntro

l m

ater

ial t

hat i

s in

tend

ed to

ver

ify

the

resu

lts in

the

expe

cted

neg

ativ

e ra

nge.

2495

5.5.

4

Pos

itive

con

trol

In

dica

tes

a co

ntro

l m

ater

ial t

hat i

s in

tend

ed to

ver

ify

the

resu

lts in

the

expe

cted

pos

itive

ra

nge.

2496

5.5.

5

Con

tain

s su

ffici

ent f

or

n

test

s

Indi

cate

s th

e to

tal

num

ber

of IV

D te

sts

that

can

be

perf

orm

ed

with

the

IV

D k

it re

agen

ts.

The

num

ber

of te

sts

that

ca

n be

per

form

ed

with

the

ki

t rea

gent

s sh

all a

ppea

r ad

jace

nt to

the

sym

bol.

NO

TE

T

he r

elat

ive

size

of

the

sym

bol a

nd t

he n

umbe

r of

test

s pe

rfor

med

can

var

y.

0518

© IS

O 2

012

– A

ll rig

hts

rese

rved

13


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.5.

6

For

IVD

pe

rfor

ma

nce

eval

uatio

n on

ly

Indi

cate

s an

IVD

de

vice

that

is

inte

nded

to b

e us

ed

only

for

eval

uatin

g its

per

form

ance

ch

ara

cter

istic

s be

fore

it is

pla

ced

on th

e m

arke

t fo

r m

edic

al d

iagn

ostic

us

e.

N

OT

E 1

A

syn

onym

is

“IV

D fo

r in

vest

igat

iona

l use

on

ly”.

NO

TE

2

A m

edic

al d

evic

e th

at is

for

IVD

per

form

ance

ev

alua

tion

only

is n

ot in

tend

ed

to b

e us

ed f

or a

n in

vitr

o di

agno

stic

exa

min

atio

n fo

r m

edic

al p

urpo

ses

(i.e.

to

yiel

d di

agno

stic

res

ults

).

Thi

s sy

mb

ol s

hall

not a

ppea

r jo

intly

on

the

labe

l or

in th

e la

belli

ng o

f an

IVD

dev

ice

bear

ing

the

sym

bol

w

hich

mea

ns th

at t

he

med

ical

dev

ice

is a

n in

vitr

o di

agno

stic

med

ical

dev

ice

inte

nded

by

the

man

ufac

ture

r to

be

used

for

an in

vitr

o di

agno

stic

ex

amin

atio

n.

A

pplic

atio

n of

IS

O 7

000

-30

83

5.6

Tra

nsf

usi

on

/infu

sio

n

5.6.

1

Sam

plin

g si

te

Indi

cate

s a

med

ical

de

vice

or

bloo

d pr

oces

sing

ap

plic

atio

n th

at

incl

udes

a s

yste

m

dedi

cate

d to

the

colle

ctio

n of

sa

mpl

es o

f a g

iven

su

bsta

nce

stor

ed in

th

e m

edic

al d

evic

e or

blo

od c

onta

ine

r.

N

OT

E

Thi

s is

not

to b

e a

ssoc

iate

d w

ith a

site

on

a pa

tient

whe

re s

ampl

es a

re

take

n.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2715

5.6.

2

Flu

id p

ath

Indi

cate

s th

e pr

esen

ce o

f a fl

uid

path

.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2722

14

© IS

O 2

012

– A

ll rig

hts

rese

rved


ISO

152

23-1

:201

2(E

)

Tab

le 1

(co

ntin

ued)

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.6.

3

Non

-pyr

oge

nic

Indi

cate

s a

med

ical

de

vice

that

is

non-

pyr

ogen

ic.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2724

5.6.

4

Dro

ps p

er

mill

ilitr

e In

dica

tes

the

num

ber

of d

rops

per

m

illili

tre.

N

OT

E

The

num

ber

of

drop

s pe

r m

illili

tre

is s

peci

fied;

20

is s

how

n as

an

exam

ple

and

shou

ld b

e re

plac

ed b

y th

e ap

prop

riate

num

ber

of d

rops

pe

r m

illili

tre.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2726

5.6.

5

Liqu

id fi

lter

with

po

re s

ize

Indi

cate

s an

infu

sion

or

tran

sfus

ion

syst

em o

f the

m

edic

al d

evic

e th

at

cont

ains

a fi

lter

of a

pa

rtic

ular

nom

inal

po

re s

ize.

N

OT

E

The

nom

inal

po

re s

ize

of t

he fi

lter

is

spec

ified

; 15

is s

how

n as

an

exam

ple

and

shou

ld b

e re

plac

ed b

y th

e ap

prop

riate

po

re s

ize.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2727

5.6.

6

One

-wa

y va

lve

Indi

cate

s a

med

ical

de

vice

with

a v

alve

th

at a

llow

s flo

w in

on

ly o

ne d

irect

ion.

N

OT

E

It is

impo

rtan

t for

th

e us

er to

kno

w t

hat t

he f

low

is

onl

y po

ssib

le in

one

di

rect

ion

and

cann

ot b

e re

vers

ed.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2728

© IS

O 2

012

– A

ll rig

hts

rese

rved

15


ISO

152

23-1

:201

2(E

) 16

© IS

O 2

012

– A

ll rig

hts

rese

rved

Ref

eren

ce n

um

ber

o

f s

ymb

ol

Tit

le o

f s

ymb

ol

Des

crip

tio

n o

f

sym

bo

la

Req

uir

em

ents

In

form

ativ

e n

ote

s R

estr

icti

on

s o

f u

se

Ad

dit

ion

al r

equ

irem

ents

IS

O 7

000

Reg

. no

.

5.7

Oth

er

5.7.

1

Tab

le 1

(co

ntin

ued)

Pat

ient

num

ber

Indi

cate

s a

uniq

ue

num

ber

asso

ciat

ed

with

an

indi

vidu

al

patie

nt.

In

Eur

ope

b,

this

sym

bol s

hall

be

expl

aine

d

in

the

info

rmat

ion

supp

lied

by t

he

m

anuf

actu

rer.

2610

a T

his

colu

mn

is a

ne

w a

dditi

on, n

ot p

revi

ousl

y e

xist

ing

in e

ither

ISO

152

23-1

or

EN

980

.

b A

t the

mom

ent,

onl

y co

unt

ries

app

lyin

g th

e pr

inci

ples

laid

dow

n in

the

EU

Dire

ctiv

es h

ave

this

req

uire

men

t or

rest

rictio

n.


ISO 15223-1:2012(E)


Annex A (informative)

Examples

A.1 Example of use of symbol 5.1.1, “Manufacturer”

Name Address

A.2 Example of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of manufacture”

Name Address 2005-06

A.3 Example of use of symbol 5.1.2, “Authorized representative in the European Community”

Name Address

A.4 Examples of use of symbol 5.1.3, “Date of manufacture”

2004-06

2004


ISO 15223-1:2012(E)


A.5 Examples of use of symbol 5.1.4, “Use-by date”

2005-09-15

2005-09

A.6 Example of use of symbol 5.1.5, “Batch code”

ABC123

A.7 Example of use of symbol 5.1.6, “Catalogue number”

ABC123

A.8 Example of use of symbol 5.1.7, “Serial number”

ABC123

A.9 Examples of use of symbols for “Sterile fluid path”

NOTE 1 Medical device contains a sterile fluid path that has been sterilized using ethylene oxide.


ISO 15223-1:2012(E)


NOTE 2 Medical device contains a sterile fluid path that has been sterilized using irradiation.

NOTE 3 Medical device contains a sterile fluid path that has been sterilized using steam or dry heat.

A.10 Examples of use of symbols for temperature limits

Upper limit of temperature

Lower limit of temperature

Temperature limit

A.11 Examples of use of symbol 5.3.8, “Humidity limitation”

A.12 Example of use of symbol 5.3.9, “Atmospheric pressure limitation”


ISO 15223-1:2012(E)


A.13 Examples of use of symbol 5.5.5, “Contains sufficient for n tests”

A.14 Example of use of symbol 5.7.1, “Patient number”

ABC123


ISO 15223-1:2012(E)


Annex B (informative)

Use of general prohibition symbol and negation symbol

B.1 General prohibition symbol

The general prohibition symbol (as used in ISO 3864-1) is intended to indicate a prohibited action. For medical device labelling, the prohibition circle with a diagonal bar should be used to mean “do not”, e.g. symbol 5.4.2 “Do not re-use”. It is sometimes used out of context in medical device labelling, e.g. to mean “does not contain”. It is important that usage be consistent with the intended meaning so that hazards do not arise from misunderstanding.

B.2 Negation symbol

Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing this meaning does not exist, should follow the method set out in Clause 7 of IEC 80416-3:2002 (a large “X” placed over the symbol). Although it is not generally recommended that this symbology be used with any of the symbols given in this part of ISO 152231, the use of the negation symbol is permitted.


ISO 15223-1:2012(E)


Bibliography

[1] ISO 3864-1, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings

[2] ISO 7000:1989, Graphical symbols for use on equipment — Index and synopsis1)

[3] ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs

[4] ISO/TR 7239, Development and principles for application of public information symbols2)

[5] ISO 15225, Medical devices — Quality management — Medical device nomenclature data structure

[6] ISO 18113-2, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use3)

[7] ISO 18113-3, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use4)

[8] ISO 18113-4, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing5)

[9] ISO 18113-5, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing6)

[10] ISO 80416-2, Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows

[11] ISO/IEC 13251, Collection of graphical symbols for office equipment

[12] IEC 60417 ISO 7000-DB, Graphical symbols for use on equipment

[13] IEC/TR 60878, Graphical symbols for electrical equipment in medical practice

[14] IEC 62366, Medical devices — Application of usability engineering to medical devices

[15] IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of graphical symbols for registration

[16] IEC 80416-3:2002, Basic principles for graphical symbols for use on equipment — Part 3: Guidelines for the application of graphical symbols

[17] EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices

1) Withdrawn. The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available online in the ISO webstore. For more information, go to http://www.iso.org/iso/publications_and_e-products/databases.htm.

2) Withdrawn.

3) Cancels and replaces EN 375:2001.





http://www.iso.org/iso/publications_and_e-products/databases.htm

ISO 15223-1:2012(E)


[18] EN 980:2008, Symbols for use in the labelling of medical devices

[19] EN 1041, Information supplied by the manufacturer of medical devices

[20] GHTF/SG1/N43:2005, Labelling for Medical Devices Available at: http://www.ghtf.org/documents/sg1/sg1final-n43.pdf


http://www.ghtf.org/documents/sg1/sg1final-n43.pdf

ISO 15223-1:2012(E)

ICS 01.080.20; 11.040.01 Price based on 23 pages

© ISO 2012 – All rights reserved


Documents

Medical devices — Symbols to be used with medical device labels, … · 2018. 12. 1. · 15223-1. Second edition. 2012-07-01. Medical devices — Symbols to be used with medical