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Packaging Materials and Systems For Medical Devices Which Are To Be Sterilized
Packaging Materials and Systems For Medical Devices Which Are To Be Sterilized
Packaging Materials and Systems For Medical Devices Which Are To Be Sterilized
Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte – Teil 1: Allgemeine Anforderungen und
Prüfverfahren
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
English version
ÜÈÉË
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
© 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.
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Microbial barrier
evaluation
Is the
packaging Yes
material intended
to be permeable
to air?
No
Is it
desirable to Yes Perform the microbial
perform the barrier test; examples
microbial are given in annex D.
barrier
test?
No
Material qualification
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
Is the
closure
intended to Yes
No
be air
permeable?
No
Are all
seals and/or Yes
closures qualified
as a microbial
barrier?
No
1 Stop valve
2 Sealing test cap
3 Vacuum pump
4 Pressure gauge