EN 868-6:2009
(Main)Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
This part of EN 868 provides test methods and values for paper used in the manufacture of preformed sterile
barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical
devices to the point of use.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.
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 4.2 to 4.3 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of
pouches and form and fill packs and lidding material for packs.
NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems
to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce
coated paper according to EN 868-7.
NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes.
The materials specified in this part of EN 868 are intended for single use only.
NOTE 4 When additional materials are used inside the sterile barrier system in order to ease the organization, drying
or aseptic presentation (e.g. inner wrap, container filters, 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, may apply.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6: Papier für Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prüfverfahren
Dieser Teil der EN 868 enthält Prüfverfahren und Werte für Papier zur Herstellung von vorgefertigten Sterilbarrieresystemen und von Verpackungssystemen, die dazu vorgesehen sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Dieser Teil der EN 868 enthält keine zusätzlichen Anforderungen zu den in EN ISO 11607-1 enthaltenen allgemeinen Anforderungen.
Die besonderen Anforderungen in 4.2 bis 4.3 können verwendet werden, um Übereinstimmung mit einer oder mehreren Anforderungen aber nicht mit allen Anforderungen der EN ISO 11607-1 nachzuweisen.
ANMERKUNG 1 Das in diesem Teil der Reihe EN 868 festgelegte Papier ist zur Herstellung von sterilen Barrieresystemen geeignet, die bei Sterilisationsverfahren mit Ethylenoxid, Strahlen oder Niedertemperatur-Dampf- Formaldehyd eingesetzt werden.
ANMERKUNG 2 Papier nach EN 868-3 kann auch für diese Sterilisationsverfahren verwendet werden.
Das in diesem Teil von EN 86 festgelegte Papier ist zur anteiligen oder vollständigen Herstellung von Beuteln, Form- und Füllpackungen und Abdeckstoffen für Verpackungen bestimmt.
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 6: Papier à destination des procédés de stérilisation à basses températures - Exigences et méthodes d'essai
La présente Partie de l’EN 868 fournit tant méthodes d'essai que valeurs relatives au papier utilisé dans la fabrication de systèmes de barrière stérile préformés et/ou des systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux, stérilisés au stade terminal, jusqu'à leur utilisation.
NOTE 1 La nécessité d’un emballage de protection peut être déterminée par le fabricant et l’utilisateur.
La présente partie de l’EN 868 présente uniquement les exigences de performance et les méthodes d’essai spécifiques des produits couverts par la présente partie de l’EN 868 mais elle n'ajoute pas ou ne modifie pas les exigences générales spécifiées dans l’EN ISO 11607-1.
En conséquence, les exigences particulières dans les paragraphes 4.2 à 4.3 peuvent être utilisées pour démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
Le papier spécifié dans la présente partie de la série EN 868 est destiné à être utilisé dans la fabrication partielle ou complète de pochettes, emballages thermoformés et opercules pour emballages.
NOTE 2 Le papier spécifié dans la présente partie de la série EN 868 est adapté pour la fabrication de systèmes de barrière stérile destinés à être utilisés dans des processus de stérilisation à l’oxyde d’éthylène ou par irradiation ou par formaldéhyde et vapeur à faible température (LTSF) et pour produire des papiers enduits d’adhésifs conformément à l’EN 868-7.
NOTE 3 Un papier conformément à l’EN 868-3 peut également être utilisé pour ces processus de stérilisation.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
NOTE 4 En cas d'utilisation de matériaux supplémentaires à l’intérieur du système de barrière stérile de manière à faciliter le rangement, le séchage ou la présentation aseptique (par exemple, enveloppe interne, filtre de conteneur, indicateurs, listes d’emballage, tapis, dispositifs de rangement des instruments,(...)
Embalaža za končno sterilizirane medicinske pripomočke - 6. del: Papir za sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode
General Information
- Status
- Withdrawn
- Publication Date
- 19-May-2009
- Withdrawal Date
- 13-Apr-2025
- 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
- 08-Feb-2017
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 15-Feb-2017
Frequently Asked Questions
EN 868-6:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods". This standard covers: This part of EN 868 provides test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. 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 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. NOTE 4 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filters, 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, may apply.
This part of EN 868 provides test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. 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 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. NOTE 4 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filters, 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, may apply.
EN 868-6:2009 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection; 11.080.30 - Sterilized packaging; 55.040 - Packaging materials and accessories. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 868-6:2009 has the following relationships with other standards: It is inter standard links to EN 868-6:1999, EN 868-6:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 868-6:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 868-6:2009 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)
SLOVENSKI STANDARD
01-oktober-2009
1DGRPHãþD
SIST EN 868-6:2000
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO 3DSLU]D
VWHULOL]DFLMVNHSURFHVH]QL]NRWHPSHUDWXUR=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature
sterilization processes - Requirements and test methods
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 6: Papier zur Sterilisation mit Sterilisationsverfahren mit niedriger Temperatur -
Anforderungen und Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 6: Papier pour la fabrication d'emballages à usage médical pour
stérilisation par l'oxyde d'éthylène ou par irradiation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-6:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 868-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-6:1999
English Version
Packaging for terminally sterilized medical devices - Part 6:
Paper for low temperature sterilization processes -
Requirements and test methods
Matériaux d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 6: Papier pour la Medizinprodukte - Teil 6: Papier für Niedertemperatur-
fabrication de systèmes de barrière stérile destinés à la Sterilisationsverfahren - Anforderungen und Prüfverfahren
stérilisation à basse température ou par irradiation -
Exigences et méthodes d'essai
This European Standard was approved by CEN on 23 April 2009.
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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-6:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Requirements .6
5 Information to be supplied by the manufacturer .7
Annex A (informative) Details of significant technical changes between this European Standard
and the previous edition .8
Annex B (normative) Method for the determination of fluorescence .9
Annex C (normative) Method for the determination of water repellency . 10
Annex D (normative) Method for the determination of pore size . 11
Bibliography . 16
Foreword
This document (EN 868-6:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by November 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 868-6:1999.
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 for
medical purposes" 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 organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 the United Kingdom.
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.
Every sterile barrier system shall fulfil the requirements of 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.
During the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003
relating to the implementation of the uncertainty of measurement concept in standards. Following this
Resolution and the corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods
needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the
information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their
next revisions.
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 series EN 868.
1 Scope
This part of EN 868 provides test methods and values for paper used in the manufacture of preformed sterile
barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical
devices to the point of use.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.
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 4.2 to 4.3 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of
pouches and form and fill packs and lidding material for packs.
NOTE 2 The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems
to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce
coated paper according to EN 868-7.
NOTE 3 Paper according to EN 868-3 can also be used for these sterilization processes.
The materials specified in this part of EN 868 are intended for single use only.
NOTE 4 When additional materials are used inside the sterile barrier system in order to ease the organization, drying
or aseptic presentation (e.g. inner wrap, container filters, 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, may apply.
2 Normative references
The following referenced documents are indispensable for the application 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 20187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for
monitoring the atmosphere and conditioning of samples (ISO 187:1990)
EN 20535, Paper and board — Determination of water absorptiveness — Cobb method (ISO 535:1991)
EN 21974, Paper — Determination of tearing resistance (Elmendorf method) (ISO 1974:1990)
EN ISO 536, Paper and board — Determination of grammage (ISO 536:1995)
EN ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation
method (ISO 1924-2:1994)
EN ISO 2758, Paper — Determination of bursting strength (ISO 2758:2001)
EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ISO 3689, Paper and board — Determination of bursting strength after immersion in water
ISO 3781, Paper and board — Determination of tensile strength after immersion in water
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 6588-2:2005, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot
extraction
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 9197, Paper, board and pulps — Determination of water-soluble chlorides
ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply.
4 Requirements
4.1 General
The requirements of EN ISO 11607-1 apply.
NOTE EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and handling with respect to their impact
on the product (e.g. electrostatic conductivity, bioburden if applicable).
4.2 Performance requirements and test methods
4.2.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is
not necessary for it to have wet strength properties or any permeability to air, so 4.2.11, 4.2.12 and 4.2.15
need not apply.
4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot
aqueous extract prepared in accordance with the method given in ISO 6588-2.
4.2.3 The average mass of 1 m² of the conditioned paper when tested in accordance with EN ISO 536 shall
be within ± 5 % of the nominal value stated by the manufacturer.
4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested in
accordance with ISO 6588-2, hot extraction method.
4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when
tested in accordance with ISO 9197 using a hot extract prepared in accordance with ISO 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when
tested in accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.2.7 When tested in accordance with Annex B the paper shall neither exhibit an increase in brightness due
to the optical brightener of more than 1 % nor have more than five fluorescent spots, each having an axis
greater than 1 mm per 0,01 m².
4.2.8 The internal tearing resistance of the conditioned paper shall be not less than 300 mN in both
machine and cross direction when tested in accordance with EN 21974.
4.2.9 The air permeance of the conditioned paper shall be not less than 0,2 µm/Pa ⋅ s at an air pressure of
1,47 kPa when tested in accordance with ISO 5636-3.
4.2.10 The bursting strength of the conditioned paper shall be not less than 200 kPa when tested in
accordance with EN ISO 2758.
4.2.11 The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with
ISO 3689 using an immersion time of 10 min.
4.2.12 The water repellency of the paper shall be such that the penetration time is not less than 20 s when
tested in accordance with Annex C.
4.2.13 When tested in accordance with Annex D, the average of the pore diameters of the ten test pieces
shall be lower or equal to 20 µm. No value shall be greater than 30 µm.
4.2.14 The tensile strength of the conditioned paper shall be not less than 4,0 kN/m in machine direction and
not less than 2,0 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.2.15 The wet tensile strength of the paper shall be not less than 0,80 kN/m in machine direction and not
less than 0,40 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.16 The su
...
SIST EN 868-6:2009は、最終滅菌された医療機器の包装に関する標準であり、特に低温滅菌プロセス向けの紙の要件と試験方法を定めています。この標準の範囲は、滅菌された医療機器の無菌性を使用時まで維持するために、あらかじめ製造されたバリアシステムや包装システムに使用される紙に関するものであり、製造者およびユーザーによって必要とされる保護包装の導入を支援します。 この標準の強みは、その性能要件と試験方法が具体的な製品に特化している点にあります。特に4.2から4.3の特定の要件は、EN ISO 11607-1の一部要件に対する適合性を示すのに有効です。これにより、医療機器の滅菌包装における品質管理が強化され、信頼性の高い包装ソリューションを提供することが可能になります。 さらに、SIST EN 868-6:2009に規定されている紙は、エチレンオキサイド、照射、低温蒸気ホルムアルデヒドなどの撲滅プロセスに適しており、これにより医療機器の滅菌ニーズに対して柔軟性と適応性を持っています。また、この標準に従った材料は、シングルユースであることが求められ、滅菌バリアシステム内での支持的な材料の使用に関しても適切な基準を設けている点が注目されます。 全体として、SIST EN 868-6:2009は、低温滅菌プロセス向けの包装における紙の特性を詳細に定義し、医療機器の安全性と有効性を確保するための重要な標準であると言えます。この標準は、実施可能な試験方法を提供することで、業界における高い品質基準を維持する役割を果たしており、医療機器の包装における重要なガイドラインとなっています。
The standard SIST EN 868-6:2009 provides essential guidelines regarding packaging materials specifically designed for terminally sterilized medical devices. Its primary focus is on the paper used in creating preformed sterile barrier systems and packaging systems that are crucial for maintaining the sterility of these medical devices until their point of use. One of the significant strengths of this standard lies in its comprehensive scope, highlighting specific test methods and performance requirements tailored to the unique needs of low-temperature sterilization processes. It effectively delineates the parameters of compliance with EN ISO 11607-1, ensuring that users can easily demonstrate adherence to international standards without needing to re-evaluate general requirements already established. Additionally, the paper specified in EN 868-6 is versatile; it can be utilized in various sterilization methods, including ethylene oxide, irradiation, and low-temperature steam formaldehyde processes, which enhances its relevance in the medical packaging sector. This adaptability is further supported by references to the suitability of related standards, such as EN 868-3, ensuring a well-rounded approach to sterile barrier system design. Another noteworthy aspect is the emphasis on single-use materials, which underscores the importance of sterility and safety in medical environments. The clarity regarding the incorporation of additional materials within the sterile barrier system is also a valuable inclusion, as it guides manufacturers and users in understanding the implications of added components during validation processes. Overall, SIST EN 868-6:2009 stands out not only for its detailed performance requirements and test methods but also for its alignment with broader international guidelines, solidifying its role as a crucial resource for manufacturers and users involved in packaging for terminally sterilized medical devices.
La norme EN 868-6:2009 constitue un référentiel essentiel pour l'emballage des dispositifs médicaux stérilisés de manière terminale, en mettant particulièrement l'accent sur l'utilisation de papier adapté aux processus de stérilisation à basse température. Son champ d'application est clairement défini, englobant les méthodes d'essai et les valeurs requises pour le papier utilisé dans la fabrication de systèmes de barrière stériles préformés, ainsi que des systèmes d'emballage destinés à maintenir la stérilité des dispositifs médicaux jusqu'au point d'utilisation. Les points forts de cette norme résident dans ses exigences de performance claires et ses méthodes d'essai spécifiques, qui sont adaptées aux produits couverts. Bien que cette partie de la norme ne modifie pas les exigences générales stipulées dans la norme EN ISO 11607-1, elle permet cependant de démontrer la conformité à certaines exigences de cette dernière. Cela souligne la pertinence et l'importance de la norme EN 868-6:2009 dans le cadre global de la stérilisation des dispositifs médicaux. Le papier spécifié dans cette norme est conçu pour être utilisé dans la fabrication, en partie ou en totalité, de sachets et d’emballages de remplissage, ainsi que de matériaux de recouvrement pour les paquets. Cela montre la polyvalence du papier défini dans la norme, qui est adapté pour les processus de stérilisation par oxyde d'éthylène, irradiation, ou vapeur formaldéhyde à basse température. Il est également important de noter que le matériau est destiné à un usage unique, ce qui est crucial pour garantir la stérilité des dispositifs médicaux. En outre, la norme inclut des précautions concernant l'utilisation de matériaux supplémentaires à l'intérieur du système de barrière stérile, ce qui démontre une prise en charge complète des conditions de validation nécessaires. Les éléments comme les filtres, les listes de conditionnement, et les sets d'organisation d'instruments sont tous couverts, ce qui renforce la fiabilité des systèmes de stérilisation. En résumé, la norme EN 868-6:2009 est un document fondamental pour les fabricants et les utilisateurs de dispositifs médicaux, offrant des exigences et des méthodes d’essai précises qui contribuent à assurer la sécurité et l’efficacité des processus de stérilisation.
SIST EN 868-6:2009는 최종 멸균된 의료 기기를 위한 포장을 위해 설계된 종이에 대한 요구 사항과 시험 방법을 명시하는 표준으로, 의료 기기의 멸균 상태를 사용 지점까지 유지하기 위한 선천적 장벽 시스템 또는 포장 시스템의 재료로서의 종이의 성능을 규명합니다. 본 표준은 EN 868의 6부로, 의료 분야의 포장 재료의 안전성과 안정성을 증진시키는 데 중요한 역할을 합니다. 이 표준의 강점 중 하나는 저온 멸균 과정에 따라 사용될 종이에 대한 명확하고 구체적인 요구 사항을 제공한다는 점입니다. EN ISO 11607-1의 일반 요구 사항을 추가하거나 수정하지 않으면서도, 4.2에서 4.3까지의 특정 요구 사항을 통해 의료 기기의 포장에 적용될 수 있는 성능 기준을 제시합니다. 이를 통해 제조업체와 사용자 모두 멸균 요구 사항을 명확하게 충족할 수 있게 됩니다. 또한, SIST EN 868-6:2009는 주머니, 포장 필름 및 포장재의 제조에 적합한 종이를 지정하며, 이는 에틸렌 옥사이드, 방사선 또는 저온 증기 포름알데히드 멸균 프로세스에서 사용되는 멸균 장벽 시스템의 제작에도 유용합니다. 이러한 다양한 적용 가능성 덕분에 이 표준은 의료 기기 포장 업계에서 널리 활용될 수 있습니다. 결론적으로, SIST EN 868-6:2009는 의료 기기의 멸균 포장 분야에서 필수적이고 신뢰할 수 있는 지침을 제공하는 표준입니다. 이 표준은 종이의 성능을 평가하고, 품질 및 안전성을 보장하기 위한 기술적 기초를 제공함으로써, 의료 기기 사용자와 제조업체 간의 신뢰를 구축하는 데 기여합니다.
Die Norm EN 868-6:2009 bietet umfassende Anforderungen und Prüfmethoden für Papier, das in der Herstellung von vorgeformten sterilen Barrièresystemen und Verpackungssystemen eingesetzt wird. Diese Systeme sind darauf ausgelegt, die Sterilität von terminal sterilisierten Medizinprodukten bis zum Einsatzpunkt aufrechtzuerhalten. Ein hervorzuhebender Aspekt dieser Norm ist die klare Abgrenzung der speziellen Anforderungen an das verwendete Papier, die nicht die allgemeinen Anforderungen der EN ISO 11607-1 modifizieren, sondern ergänzen. Ein wesentlicher Stärke der EN 868-6:2009 ist die detaillierte Beschreibung der Prüfmethoden und Werte, die notwendig sind, um die Leistung des Papiers zu überprüfen. Das Papier ist für verschiedene Niedertemperatur-Sterilisationsprozesse konzipiert, einschließlich Ethylenoxid, Bestrahlung und Niedertemperaturdampf-Formaldehyd-Sterilisation. Diese Flexibilität in den Anwendungsbereichen erweitert die Relevanz der Norm in der medizinischen Verpackungsindustrie, da sie eine breite Palette von Sterilisationsmethoden abdeckt. Die Norm beschreibt spezifische Materialien, die ausschließlich für den Einmalgebrauch bestimmt sind, was die Sicherheit und Effektivität der Verpackungen erhöht. Außerdem berücksichtigt sie die Möglichkeit, zusätzliche Materialien innerhalb des sterilen Barrièresystems zu verwenden, um eine bessere Organisation oder aseptische Präsentation der Medizinprodukte zu gewährleisten. Dies zeigt, dass die Norm auch mit den praktischen Anforderungen der Anwender an die Sterilität und Handhabung der Produkte korreliert. Insgesamt ist die EN 868-6:2009 ein unverzichtbares Dokument für Hersteller und Anwender von medizinischen Geräten, da sie sicherstellt, dass die Verpackungen den hohen Anforderungen an die Sterilität entsprechen und somit einen entscheidenden Beitrag zur Patientensicherheit leisten. Durch die Fokussierung auf spezifische Testmethoden und Anforderungen hebt sich die Norm als eine zuverlässige Grundlage für Qualitätssicherung in der Herstellung von sterilen Verpackungen hervor.
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