DEUTSCHE NORM May 1997

Packaging materials and systems for medical

devices which are to be sterilized {
Part 1: General requirements and test methods
English version of DIN EN 868-1 EN 868-1
ICS 11.080; 55.040

Descriptors: Packaging material, medical devices, sterilization, testing, requirements.

Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte – Teil 1: Allgemeine Anforderungen und
Prüfverfahren

European Standard EN 868-1 : 1997 has the status of a DIN Standard.

A comma is used as the decimal marker.

National foreword
This standard has been prepared by CEN/TC 102.
The responsible German body involved in its preparation was the Normenausschuß Medizin (Medical Standards
Committee).

EN comprises 21 pages.

© No part of this standard may be reproduced without the prior permission of Ref. No. DIN EN 868-1 : 1997-05
DIN Deutsches Institut für Normung e.V., Berlin. English price group 12 Sales No. 1112
Beuth Verlag GmbH, Berlin, has the exclusive right of sale for German Standards (DIN-Normen). 01.98
 EN 868-1

February 1997

ICS 11.080; 55.040

Descriptors: Packaging material, medical devices, sterilization, testing, requirements.

English version

Packaging materials and systems for medical

devices which are to be sterilized
Part 1: General requirements and test methods

Matériaux et systèmes d’emballages pour Verpackungsmaterialien und -systeme für

les dispositifs médicaux devant être zu sterilisierende Medizinprodukte –
stérilisés – Partie 1: Exigences générales et Teil 1: Allgemeine Anforderungen und
méthodes d’essai Prüfverfahren

This European Standard was approved by CEN on 1997-01-27.

CEN members are bound to comply with the CEN/CENELEC 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 national standards may be
obtained on application to the Central Secretariat or to any CEN member.
The European Standards exist in three official versions (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 of Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland, and the United Kingdom.

ÜÈÉË
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

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

© 1997. CEN – All rights of exploitation in any form and by any means Ref. No. EN 868-1 : 1997 E
reserved worldwide for CEN national members.
Page 2
EN 868-1 : 1997
 Page 3
EN 868-1 : 1997
Page 4
EN 868-1 : 1997
 Page 5
EN 868-1 : 1997
Page 6
EN 868-1 : 1997
 Page 7
EN 868-1 : 1997
Page 8
EN 868-1 : 1997
 Page 9
EN 868-1 : 1997
Page 10
EN 868-1 : 1997
 Page 11
EN 868-1 : 1997
Page 12
EN 868-1 : 1997

Microbial barrier
evaluation

Is the
packaging Yes
material intended
to be permeable
to air?

No

Perform the air

impermeability test;
examples are given in
annex C.

Is it
desirable to Yes Perform the microbial
perform the barrier test; examples
microbial are given in annex D.
barrier
test?

No

Material qualification

Figure B.1: Microbial barrier evaluation scheme (continued)

 Page 13
EN 868-1 : 1997

Closure/seal qualification

Are all
materials Yes
qualified as a
microbial
barrier?
Perform the test for
Does the determination of the
No packaging Yes impermeability and
system use seals continuity of seals;
to provide a examples are given
microbial in annex F.
barrier?

No

Yes Does the

packaging system
use any
closures?

Is the
closure
intended to Yes
No
be air
permeable?

No

Perform the Perform the

mircrobial barrier microbial properties
test for impermeable test for permeable
closures; examples closures; examples
are given in annex G. are given in annex E.

Are all
seals and/or Yes
closures qualified
as a microbial
barrier?

No

Packaging system Packaging system

NOT qualified qualified

Figure B.1: Microbial barrier evaluation scheme (concluded)

Page 14
EN 868-1 : 1997
 Page 15
EN 868-1 : 1997
Page 16
EN 868-1 : 1997
 Page 17
EN 868-1 : 1997
Page 18
EN 868-1 : 1997

1 Stop valve
2 Sealing test cap
3 Vacuum pump
4 Pressure gauge

Figure G.1: Test cap

 Page 19
EN 868-1 : 1997
Page 20
EN 868-1 : 1997
 Page 21
EN 868-1 : 1997