EN 868-7:1999
(Main)Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
This Part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with prEN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.
Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier für die Herstellung von heißsiegelfähigen Verpackungen für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen - Anforderungen und Prüfverfahren
Dieser Teil der Reihe EN 868 enthält Beispiele von besonderen Anforderungen und Prüfverfahren für heißsiegelfähiges, klebemittelbeschichtetes Papier, hergestellt aus Papier nach prEN 868-6, das für die Herstellung von Verpackungen für Medizinprodukte verwendet werden wird, die in der Endpackung mit Ethylenoxid oder Strahlen sterilisiert werden. In diesem Teil wurden keine zusätzlichen Anforderungen zu den im Teil 1 enthaltenen allgemeinen Anforderungen aufgenommen. Er stellt einen Leitfaden dar, der auf verschiedenen Bestandteilen entsprechender früher nationaler Normen basiert.
Matériaux et systèmes d'emballages pour les dispositifs médicaux devant être stérilisés - Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages thermoscellables à usage médical pour stérilisation à l'oxyde d'éthylène ou par irradiation - Exigences et méthodes d'essai
Cette partie de la série de normes EN 868 donne des exemples d'exigences particulières et de méthodes d'essai pour le papier enduit adhésif thermoscellable, fabriqué à partir de papier conforme au prEN 868-6, pour utilisation comme emballage des dispositifs médicaux devant être stérilisés au stade terminal par l'oxyde d'éthylène ou par irradiation. Cette partie n'ajoute pas de nouvelles exigences aux exigences générales de la partie 1 mais propose un guide basé sur divers éléments des anciennes normes nationales applicables.
Embalažni materiali in sistemi za medicinske pripomočke, ki jih je treba sterilizirati - 7. del. Papir, oplemeniten z lepilom, za izdelavo embalažnih enot pri toplotnem lepljenju za uporabo v medicini pri sterilizaciji z etilenoksidom ali obsevanjem - Zahteve in preskusne metode
General Information
- Status
- Withdrawn
- Publication Date
- 22-Jun-1999
- Withdrawal Date
- 19-May-2009
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 4 - Packaging materials
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 20-May-2009
- Completion Date
- 20-May-2009
Relations
- Effective Date
- 30-May-2009
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 868-7:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods". This standard covers: This Part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with prEN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.
This Part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with prEN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.
EN 868-7:1999 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection; 55.040 - Packaging materials and accessories. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 868-7:1999 has the following relationships with other standards: It is inter standard links to EN 868-7:2009; is excused to EN 868-1:1997. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 868-7:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2000
(PEDODåQLPDWHULDOLLQVLVWHPL]DPHGLFLQVNHSULSRPRþNHNLMLKMHWUHEDVWHULOL]LUDWL
GHO3DSLURSOHPHQLWHQ]OHSLORP]DL]GHODYRHPEDODåQLKHQRWSULWRSORWQHP
OHSOMHQMX]DXSRUDERYPHGLFLQLSULVWHULOL]DFLML]HWLOHQRNVLGRPDOLREVHYDQMHP
=DKWHYHLQSUHVNXVQHPHWRGH
Packaging materials and systems for medical devices which are to be sterilized - Part 7:
Adhesive coated paper for the manufacture of heat sealable packs for medical use for
sterilization by ethylene oxide or irradiation - Requirements and test methods
Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 7:
Klebemittelbeschichtetes Papier für die Herstellung von heißsiegelfähigen Verpackungen
für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen - Anforderungen
und Prüfverfahren
Matériaux et systemes d'emballages pour les dispositifs médicaux devant etre stérilisés -
Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages thermoscellables a
usage médical pour stérilisation a l'oxyde d'éthylene ou par irradiation - Exigences et
méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-7:1999
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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