EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN ISO 11607-1
April 2006
ICS 11.080.30 Supersedes EN 868-1:1997
English Version
Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2006)
Emballages des dispositifs médicaux stérilisés au stade
terminal - Partie 1: Exigences relatives aux matériaux, aux
systèmes de barrière stérile et aux systèmes d'emballage
(ISO 11607-1:2006)
Verpackungen für in der Endverpackung zu sterilisierende
Medizinprodukte - Teil 1: Anforderungen an Materialien,
Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2006)
This European Standard was approved by CEN on 13 April 2006.
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.
This European Standard exists 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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© 2006 CEN All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members.
Ref. No. EN ISO 11607-1:2006: E
Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 22:05:27 BST 2006, Uncontrolled Copy, (c) BSI
