prEN 868-2
(Main)Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
This document specifies test methods and values for sterilization wrap made of
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Sterilisierverpackung - Anforderungen und Prüfverfahren
In diesem Dokument werden Prüfverfahren und werte für Sterilisierverpackungen festgelegt, die aus
- gekrepptem Papier zum einmaligen Gebrauch,
- Vliesstoffe zum einmaligen Gebrauch,
- gewebten textilen Materialien zur Wiederverwendung,
bestehen und als Sterilbarrieresysteme und/oder Verpackungssysteme für in der Endverpackung zu sterilisierende Medizinprodukte verwendet werden.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607-1 und EN ISO 11607-2 festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in diesem Dokument betrachteten Produkte sind.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : Enveloppe de stérilisation - Exigences et méthodes d'essai
Le présent document spécifie des méthodes d’essai et des valeurs applicables aux enveloppes de stérilisation en
- papier crêpé à usage unique ;
- matériaux non tissés à usage unique ;
- matériaux textiles tissés réutilisables
employées comme systèmes de barrière stérile et/ou systèmes d’emballage destinés à des dispositifs médicaux stérilisés au stade terminal.
Mis à part les exigences générales spécifiées dans l’EN ISO 11607-1 et l’EN ISO 11607-2, la présente partie de l’EN 868 spécifie les matériaux, les méthodes d’essai et les valeurs spécifiques aux produits couverts par le présent document.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Sterilizacijski embalažni materiali za zavijanje - Zahteve in preskusne metode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 868-2:2024
01-junij-2024
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Sterilizacijski
embalažni materiali za zavijanje - Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap -
Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Sterilisierverpackung - Anforderungen und Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : Enveloppe
de stérilisation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-2
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.040 Materiali in pripomočki za Packaging materials and
pakiranje accessories
oSIST prEN 868-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 868-2:2024
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oSIST prEN 868-2:2024
DRAFT
EUROPEAN STANDARD
prEN 868-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2024
ICS 11.080.30 Will supersede EN 868-2:2017
English Version
Packaging for terminally sterilized medical devices - Part
2: Sterilization wrap - Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2 : Enveloppe de stérilisation - sterilisierende Medizinprodukte - Teil 2:
Exigences et méthodes d'essai Sterilisierverpackung - Anforderungen und
Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-2:2024 E
worldwide for CEN national Members.
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oSIST prEN 868-2:2024
prEN 868-2:2024 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements . 7
5 Performance requirements and test methods . 7
5.1 General. 7
5.2 Specific requirements for wrap made of creped paper . 8
5.3 Specific requirements for wrap made of nonwoven material .
...
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