DEUTSCHE NORM January 2001

Medical gloves for sinEle use

Part 1: Requirements and testing for freedom fromr holes DIN
(: English version of DIN EN 4SS_1 EN 455-1
lcs 11.140
Supersedes
July 1998 edition.
Medizinische Handschuhe zum einmaligen Gebrauch _
Teil 1: Anforderungen und prtjfung auf bichtheit

European standard EN 45s-i :2000 has the status of a DrN Standard.

National foreword
This standard has been prepared by CEN/TC 205 'Non-active rnedical
devices, (Secretariat: United King-
dom).
o The responsible Germal body involved in its preparation wias the
Norr,nenausschuss Medizin (Medical
Standards Committee), Technical Committee Medizinische Einmalhandschuhe.

Amendments
This standard differs from DIN EN 455-1, July 1998 edition, in that
clause 6 fras been specified in more detail.

Previous edition
DIN EN 455-1: 1998-07.

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EN comprises 5 pages.
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BiS LIBRARY

p tttg nart ol this standard may be reproduced

D/N Deutsches /n stitut fiir Nomung e. V., Bertin Ref. No. DIN EN 455-1 : 2001-01
has the exclusive right of sale for German Stan English price group 07 Sales No. t l0Z
05.01
 EUFIOPEAN STANDAFID EN 455-1
NORME EUFIOPEENNE
EUFIOPASCHE NOFIM October 2000

tcs 13.340 Supersedes EN 455-1 : 1993.

t

English version

Medical gloves for single use

Part 1: Requirements and testing for freedom frclm holes

Gants m6dicaux non r6utilisables - Medizinische Handschuhe zum

Partie 1: D6tection des trous - einmaligen Gebrauch - Teil 1: Anfor-
Prescriptions et essais derungen und Pr0fung auf Dichtheit

This European Standard was approved by CEN on 2000-09-'X6.

CEN members are bound to comply with the CEN/OENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a
national standard without any alteration.
Up-to-date lists and bibliographical references concerning such nationalstand-
ards may be obtained on application to the Oentral Secretariat or to any
CEN member.
The European Standards exist in three officialversions (English, French, German).
A version in any other language made by translation under the responsibility of a
CEN member into its own language and notified to the Central Secretariat has the
same status as the official versions.
CEN members are the national standards bodies clf Austria, Belgium, the Czech
Republic, Denmark, Finland, France, Germany, Greece, lceland, lreland, ltaly,
Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland,
and the United Kingdom.

CEN
European Committee for Stanclardization
Comit6 Euroo6en de Normalisation
Europdisches Komitee ftir Norimung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

I
t.,
I' means
@ 2000. CEN - All rights of exploitation in any form and by any Ref. No. EN 455-1 : 2000 E
reserved worldwide for CEN national members.
 Page 2
EN 455-1 : 2000

Foreword

This European St 'has been prepared

by Technical Committee CEN/TC' 205 "Non-active medical
s
devices", the sec of which is hetd by BSl.

This European Sta supersedes EN 485-1 :1 993

This European Sta shall be given the status of a national standard, either
by. publication of an identical
text or by at the latest by Aprir2001, and confricting nationarstandards
the latest by Aprit 2001 shail be withdrawn at

This European S has been prepared under a mandate given to cEr,,r by

the European commission
and the European Free 'rade ,Association, and supports
essentiat requirements of EU directive(s).

For relationship with Directive(s), see informative Annex ZA, which is an

integrar part of this standard.
This European applies to medicar groves for singre use and has been prepared
parl addresses freedom rom holes; Part 2 addresses physical in three parts. This
properties ancr part 3 addresses requirements
and testing for evaluation.

According to the NELEo Internal Regulations, the national standards

organizations of the following
countries are bound to nplement this European standard:
Austria, Bergium, czecn Repubric, Denmark,
Finland, France, Germa , Greece, lceland, rrerand,
rtary, Luxembourg, r,Jetherrands, r.tor*ay, portugal,
Spain, Sweden, Switzerl d and the United Kingdom.

Scope

This part of this Standard ecifies requirements and gives the test method for medical gloves
for single use in order
to determine lreedom holes.

NOTE Attention drawn to EN 374-1 "Protective gloves against chermicals

Terminology and rrf ormance requirements',.
and micro-organisms - part 1:
Normative re

This European Standard Incorporates by dated or undated reference, provisions

from other publications. These
normative relerences are cited at the appropriate places in
the text and the publications are listed hereafter. For
dated references, amendments lo or revisions of any of these publications apply
to this European
Standard only when
publication re{erred to
:d in it by amendment or revision. For undaled references the latest
s (including amendments).
edition of the I
lso 2859-1
Sampling procedures inspection by attributes - part 1: sampling plans indexed
(AQL) for lot-by-tot by acceptabre quality level

3 Term and definition

For the purposes of this stfndard the foilowing term

and definition appry:

3.1
medical gloves for single] use

gloves intended for use in medical field to protect patient and user from cross-contamination.
ihe
 Page 3
EN 455-1 :2000
4 Bequire

Medical gloves single use shall not leak when tested in accordance with clause 5.

5 Wa s test for detection of holes

5.1 Referee lesting d,

Vertically positi a filling tube of dimensions shown in figure 1 or ol dimensions to fit the glove and such that the tube
is capable of any of the 1000 ml of water that may exceed the naturalfiltvotume of the glove.

Attach the glove the filling tube, overlapping the cuff by a maximunr of 40 mm over the end of the tube and secure
it by suitable m to obtain a watertight seal without damaging the glove (see figure 1).

Add 1000 ml r ml of water at a temperature of (15 to 35) oC into the open end of the filling tube, allowing the water
to pass freely the glove.

NOTE of the water may remain in the filling tube depernding on the glove being tested.

lmmediately the glove visually tor water leakage. Allow the gllove to hang and visually inspect the glove for
water leakage atter a period of 2 min to 3 min.

lf, because of of the glove, the water does not rise to within 40 mm of the cuff end, raise the glove after
the second by a suitable means until the water level reaches 40 mm from the cuff end. Inspect visually
the previously portion of the glove after a further period of 2 min to 3 min,

Disregard within 40 mm of the cuff.

5.2 Routine

Routine testing be either by the watertightness test given in 5.1 or by another test which is validated against this
test.

,6 Sam inspection level and AQL

Each lot shall be in accordance with ISO 2859-1 general inspection level 1, but utilising a minimum sample
size and lding acceptance/rejection numbers equivalent to sample size code letter L. When tested by the
method in 5.1 for referee purpose, the compliance level for freedom from holes shall be an AQL of 1,5.

NOTE inspection level meets the requirements of Annex lV point 6.3 of the Medical Devices Directive,
93t42/E and does not entail excessive sample sizes whic;h would impact on manufacturing and testing
costs. A sample size equivalent to sample size code letter L is necessary to ensure that an adEluate
assessm of the quality of the lot is obtained when the lot size is small or unknown.

Test

Any test report ll include at least the following information:

- a reference this part ol EN 455;

- the type of and manufacturing batch code;

- the name address of the manufaclurer or distributor and test laboratory,,if different; iI
I

- the date of e test performed;

- the test ts (batch size, sample size, number ol non-confonming gloves).

ii
ri
'i
Page 4
EN 455-1 :2000

Dimensions in millimeters

Key

a)Gutf end of glove

b)Locking device
c)Fill tube overlapping

1 - Watertlghtnese lcet - Filling

 page 5
EN 455-1 :2000

Annex zn (informative)

clauses of this European standard addressing essential requirements or other provisions of EU

Directives
This European standard has been prepared under a mandate given to CEN/CENELEC by the European
commission and the European Free Trade Association and supports essential r,equirements of EU directive
93/42/EEC. !

WARNING other requirements and other EU Directives may be applicable to the product(s) falling within
the
scope of this standard.

The following clauses of this standard, as detailed in table 2A.1, aret likely to support requirements of Directive
93/42/EEC.

Cornpliance with the clauses of this standard provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.

Tabfe ZA.1 'Correspondence between this European Stanrdard and EU Directives

Clause/sub-clause of this Corresponding essential

European Standard reguirement of Directive
93t42|EEC

1, 2, 3, 7.2, 9.1

1, 2, 3, 7.2