EN 868-5:2018
(Main)Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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
- Withdrawal Date
- 29-Jun-2019
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 4 - Packaging materials
- Current Stage
- 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
- Start Date
- 11-Nov-2024
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 26-Dec-2018
Overview
EN 868-5:2018 is a CEN European standard that defines requirements and test methods for sealable pouches and reels used as sterile barrier systems for terminally sterilized medical devices. It covers products made from a porous material face combined with a plastic film face (plastic/porous laminates) intended to maintain sterility to the point of use. The standard complements general packaging requirements in EN ISO 11607‑1 and validation requirements in EN ISO 11607‑2 by specifying materials, test methods and numeric values particular to pouches and reels. Materials covered are intended for single use only.
Key topics and technical requirements
- Material construction
- Porous material must comply with EN 868 parts 2, 3, 6, 7, 9 or 10.
- Plastic film must be a composite of two or more layers and be free from pinholes and foreign matter after visual inspection.
- Interply bond of plastic layers shall not separate or become cloudy after the intended sterilization (see Annex B).
- Mechanical performance
- Plastic film breaking factor: ≥ 20 N per 15 mm width (machine and cross direction) when tested to ASTM D882.
- Seal(s) overall width: ≥ 6 mm (sum of ribs for ribbed seals).
- Seal and closure
- Pouches: sealed on three sides; reels: sealed along parallel sides.
- Pouches must allow peelability (thumb notch ≤ 12 mm or a lip ≥ 1.0 mm) to enable aseptic opening.
- Seal strength requirements (Annex D): minimum 1.5 N/15 mm for steam and 1.2 N/15 mm for other processes for healthcare facility use (industry may set different values based on validation).
- Seals must be continuous and not cause disruption of adjacent porous material upon opening.
- Process indicators
- Type I (process) indicators printed on pouches/reels must comply with EN ISO 11140‑1 and be ≥ 100 mm² each.
- Test methods and annexes
- Annex B: resistance to sterilization
- Annex C: pinhole detection in laminate
- Annex D: seal strength
- Annex E: peel characteristics
- Annex F: fibre orientation
Applications
- Design, manufacture and qualification of sealable pouches and reels for steam, ethylene oxide, irradiation and other sterilization processes.
- Packaging validation and quality control for medical device manufacturers, contract packagers and test laboratories.
- Selection of sterile barrier systems by hospital sterilization departments and sterile services units to ensure reliable aseptic presentation.
Who should use this standard
- Packaging engineers and product developers for medical devices
- Regulatory and quality assurance teams (medical device industry)
- Sterile processing departments in healthcare facilities
- Test laboratories performing material and seal validation
- Contract packagers and suppliers of sterile packaging materials
Related standards
- EN ISO 11607‑1 / EN ISO 11607‑2 (general packaging and process validation)
- EN 868 parts 2, 3, 6, 7, 9, 10 (material-specific requirements)
- EN ISO 11140‑1 (chemical indicators)
- ASTM D882, ASTM F88 (tensile and seal tests referenced)
Keywords: EN 868-5, sealable pouches, reels, porous materials, plastic film, sterile barrier systems, seal strength, sterilization packaging, test methods.
Frequently Asked Questions
EN 868-5:2018 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods". This standard covers: 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.
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.
EN 868-5:2018 is classified under the following ICS (International Classification for Standards) categories: 11.080.30 - Sterilized packaging. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 868-5:2018 has the following relationships with other standards: It is inter standard links to EN 868-5:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN 868-5:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
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
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
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
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