Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
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.
The materials specified in this part of EN 868 are intended for single use only.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für siegelfähige Klarsichtbeutel und  schläuche aus porösem Material fest, die entweder EN 868 Teil 2, Teil 3, Teil 6, Teil 7, Teil 9 oder Teil 10 entsprechen und aus Kunst¬stoff Verbundfolie nach Abschnitt 4 hergestellt werden. Diese siegelfähigen Klarsichtbeutel und  schläuche werden als Sterilbarrieresysteme und/oder Verpackungssysteme verwendet, die dafür bestimmt sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
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, die spezifisch für die in diesem Dokument betrachteten Produkte sind.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs relatives aux sachets et gaines scellables fabriqués à partir de matériaux poreux conformes à l’EN 868, Partie 2, 3, 6, 7, 9 ou 10, et en film plastique, conformément à l’Article 4. Ces sachets et gaines scellables servent de systèmes de barrière stérile et/ou de systèmes d’emballage destinés à maintenir l’état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu’au point d’utilisation.
Outre les exigences générales telles que 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 traités dans le présent document.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.

Embalaža za končno sterilizirane medicinske pripomočke - 5. del: Vrečke in zvitki papirja z možnostjo tesnjenja (samolepilni) iz poroznega materiala in s plastičnimi folijami - Zahteve in preskusne metode

Ta del standarda EN 868 podaja preskusne metode in vrednosti za vrečke in zvitke iz poroznega materiala z možnostjo tesnjenja, izdelane v skladu s standardom EN 868, deli 2, 3, 6, 7, 9 ali 10, in plastične folije v skladu s točko 4, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
OPOMBA 1: Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik. Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki veljajo za proizvode, zajete v tem delu standarda EN 868, vendar ne dodaja ali spreminja splošnih zahtev, podanih v standardu EN ISO 11607-1.
Posebne zahteve iz točk od 4.2 do 4.5 je mogoče uporabiti za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.
OPOMBA 2: Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, kazalniki filtrov, embalažni listi, podloge, kompleti organizatorjev za inštrumente, obloge za pladnje ali dodatni ovoj okoli medicinskega pripomočka), se lahko uporabljajo druge zahteve, vključno z ugotavljanjem sprejemljivosti teh materialov med preverjanjem.

General Information

Status
Published
Publication Date
18-Dec-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
19-Dec-2018
Completion Date
19-Dec-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und PrüfverfahrenEmballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essaiPackaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je istoveten z:EN 868-5:2018SIST EN 868-5:2019en,fr,de01-marec-2019SIST EN 868-5:2019SLOVENSKI

STANDARDSIST EN 868-5:20091DGRPHãþD
SIST EN 868-5:2019
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 868-5
December
t r s z ICS
s sä r z rä u r Supersedes EN
z x zæ wã t r r {English Version
Packaging for terminally sterilized medical devices æ Part

wã Sealable pouches and reels of porous materials and plastic film construction æ Requirements and test methodsEmballages des dispositifs médicaux stérilisés au stade terminal æ Partie

wã Sachets et gaines scellables constitués d 5une face matière poreuse et d 5une face film plastique æ Exigences et méthodes d 5essai

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte æ Teil

wã Siegelfähige Klarsichtbeutel und æschläuche aus porösen Materialien und KunststoffæVerbundfolie æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on

t r August
t r s zä

egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels

t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

z x zæ wã t r s z ESIST EN 868-5:2019

EN 868-5:2018 (E) 2 Contents Page European foreword ....................................................................................................................................................... 3 Introduction .................................................................................................................................................................... 5 1 Scope .................................................................................................................................................................... 6 2 Normative references .................................................................................................................................... 6 3 Terms and definitions ................................................................................................................................... 6 4 Requirements ................................................................................................................................................... 7 4.1 General ................................................................................................................................................................ 7 4.2 Materials ............................................................................................................................................................. 7 4.2.1 Porous material ............................................................................................................................................... 7 4.2.2 Plastic film ......................................................................................................................................................... 7 4.3 Construction and design ............................................................................................................................... 8 4.4 Process indicator ............................................................................................................................................. 8 4.5 Performance requirements and test methods ..................................................................................... 8 4.6 Marking ............................................................................................................................................................... 9 4.6.1 Pouches and reels ........................................................................................................................................... 9 4.6.2 Transport and/or storage packaging ................................................................................................... 10 5 Information to be supplied by the manufacturer ............................................................................. 10 Annex A (informative)

Details of significant technical changes between this document and the previous edition .................................................................................................................................... 11 Annex B (normative)

Method for the determination of resistance to the intended sterilization process .................................................................................................................................... 12 Annex C (normative)

Method for the determination of pinholes in plastic laminate ...................... 13 Annex D (normative)

Method for the determination of the strength of the seal for pouches and reel material .......................................................................................................................................... 15 Annex E (normative)

Method for the determination of peel characteristics of paper/plastic laminate products ........................................................................................................................................ 18 Annex F (normative)

Method for the determination of fibre orientation ............................................ 20 Bibliography ................................................................................................................................................................. 21

SIST EN 868-5:2019

EN 868-5:2018 (E) 3 European foreword This document (EN 868-5:2018) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2019, and conflicting national standards shall be withdrawn at the latest by June 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-5:2009. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: — Part 2: Sterilization wrap — Requirements and test methods; — Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods; — Part 4: Paper bags — Requirements and test methods; — Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods; — Part 6: Paper for low temperature sterilization processes — Requirements and test methods; — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods; — Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods; — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods; — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods. In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” has prepared the EN ISO 11607 series “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1) and validation requirements for forming, sealing and assembly processes (Part 2). According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, SIST EN 868-5:2019

EN 868-5:2018 (E) 4 Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 868-5:2019

EN 868-5:2018 (E) 5 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices”. Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards. It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series. SIST EN 868-5:2019

EN 868-5:2018 (E) 6 1 Scope This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. 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. The materials specified in this part of EN 868 are intended for single use only. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 868-2:2017, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods EN 868-3:2017, Packaging for terminally sterilized medical devices — Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods EN 868-6:2017, Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization processes — Requirements and test methods EN 868-7:2017, Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods EN 868-9:2018, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods EN 868-10:2018, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1) EN ISO 11607-1:2017, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ASTM D882:2012, Test Methods for Tensile Properties of the Thin Plastic Sheeting ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2017 apply. SIST EN 868-5:2019

EN 868-5:2018 (E) 7 ISO and IEC maintain terminological databases for use in standardization at the following addresses: — IEC Electropedia: available at http://www.electropedia.org/ — ISO Online browsing platform: available at http://www.iso.org/obp 4 Requirements 4.1 General For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1 shall apply. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 868-5 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-5 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply. 4.2 Materials 4.2.1 Porous material The porous material shall comply with the requirements of Clause 4 of either EN 868-2:2017, EN 868-3:2017, EN 868-6:2017, EN 868-7:2017, EN 868-9:2018 or EN 868-10:2018. If the intended method of sterilization is irradiation only, the requirements for wet strength properties and permeability to air for porous materials are not applicable. 4.2.2 Plastic film 4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance with Annex B the plastics interply bond shall not separate nor become cloudy. 4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C. 4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4.5. NOTE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect. 4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified. SIST EN 868-5:2019

EN 868-5:2018 (E) 8 4.2.2.5 The breaking factor of the plastics film, machine direction and cross direction, shall be not less than 20 N per 15 mm width when tested in accordance with ASTM D882:2012 (Method A). 4.3 Construction and design 4.3.1 Reel material shall be constructed from one web of porous material and one web of plastic film, sealed together along parallel sides. Pouches shall be constructed from one web of porous material and one web of plastic film by sealing three sides and may include an area to effect closure of the pouch. 4.3.2 The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the widths of the ribs shall be not less than 6 mm. 4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable the two webs to be separated and peeled apart. NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided that this does not impair peelability. 4.3.4 One of the materials of a pouch shall b

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