1、September 2009DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.30!$YX“154535
2、6www.din.deDDIN EN 868-5Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic filmconstruction Requirements and test methodsEnglish version of DIN EN 868-5:2009-09Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte
3、Teil 5: Siegelfhige Klarsichtbeutel und -schluche aus porsen Materialien undKunststoff-Verbundfolie Anforderungen und PrfverfahrenEnglische Fassung DIN EN 868-5:2009-09SupersedesDIN EN 868-5:2002-01www.beuth.deDocument comprises pages22DIN EN 868-5:2009-09 National foreword This standard has been pr
4、epared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-04 AA Sterilgutversorgung. The DIN Standard co
5、rresponding to the International Standard referred to in this document is as follows: ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN 868-5:2002-01 as follows: a) Changes in order to align this European Standard with the DIN EN ISO 11607 series, in particular by: amending the main
6、 element of the title, the scope and the terminology; using DIN EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems; deleting requirements that are covered by DIN EN ISO 11607 (such as requirements on leaching of toxic
7、 substances). b) In addition to a) first dash, the scope has been modified to: explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; clarify that the materials covered by this European Standard are intended for single use only; eli
8、minate the restriction to heat and self-sealability; to include also porous materials according to DIN EN 868-2, DIN EN 868-6, DIN EN 868-7, DIN EN 868-9 and DIN EN 868-10. c) A definition of health care facility has been added. d) An explanatory note has been inserted to refer the user of this Euro
9、pean Standard to the general requirements on conditions during production and handling with respect to their impact on the product in DIN EN ISO 11607. e) Requirements on indicators have been amended on the basis of DIN EN ISO 11140-1. f) Requirements on the construction and design have been amended
10、 in particular with regard to the closure of the pouch and/or reel and the protrusion of one web. g) Requirements on the seal, the seal strength and test method have been amended. h) The test method for resistance to the sterilization process has been amended by eliminating the restriction to moist
11、heat and ethylene oxide sterilization processes. i) Requirements on marking have been amended. j) Requirements on information to be provided by the manufacturer have been amended. k) The test reports in the annexes have been amended. l) The informative annex on dimensions and tolerances has been del
12、eted. m) The text has been editorially revised (e.g. by updating normative and informative references). 2 DIN EN 868-5:2009-09 Previous editions DIN 58953-4: 1982-11, 1987-01 DIN EN 868-5: 1999-08, 2002-01 National Annex NA (informative) Bibliography DIN ISO 8601, Data elements and interchange forma
13、ts Information interchange Representation of dates and times 3 DIN EN 868-5:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-5 May 2009 ICS 11.080.30 Supersedes EN 868-5:1999 English Version Packaging for terminally sterilized medical devices Part 5
14、: Sealable pouches and reels of porous materials and plastic film construction Requirements and test methods Matriaux demballage pour les dispositifs mdicaux striliss au stade terminal Partie 5: Sachets et gaines thermoscellables constitus dune face matire poreuse et dune face film plastique Exigenc
15、es et mthodes dessai Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 5: Siegelfhige Klarsichtbeutel und -schluche aus porsen Materialien und Kunststoff-Verbundfolie Anforderungen und Prfverfahren This European Standard was approved by CEN on 23 April 2009. CEN members ar
16、e bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard 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 t
17、he 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
18、 status as theofficial 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,Roman
19、ia, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved w
20、orldwide for CEN national Members. Ref. No. EN 868-5:2009: EEN 868-5:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Requirements .65 Information to be supplied by the manufacturer 8Annex A (informative) Details of significant technical
21、changes between this European Standard and the previous edition 10Annex B (normative) Method for the determination of resistance to the intended sterilization process 11Annex C (normative) Method for the determination of pinholes in plastic laminate 12Annex D (normative) Method for the determination
22、 of the strength of the seal joint for pouches and reel material . 14Annex E (normative) Method for the determination of peel characteristics of paper/plastic laminate products . 16Annex F (normative) Method for the determination of fibre orientation 17Bibliography . 18DIN EN 868-5:2009-09 EN 868-5:
23、2009 (E) 3 Foreword This document (EN 868-5:2009) 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
24、 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 f
25、or identifying any or all such patent rights. This document supersedes EN 868-5:1999. 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
26、 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 metho
27、ds; 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
28、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 meth
29、ods. 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, s
30、terile 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: Au
31、stria, 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. DIN EN
32、868-5:2009-09 EN 868-5:2009 (E) 4 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
33、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
34、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 measureme
35、nt 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 availa
36、ble 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
37、 EN ISO 11607 series that is the basic reference for all parts of the series EN 868. DIN EN 868-5:2009-09 EN 868-5:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9
38、 or 10 and plastic film complying with Clause 4 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. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user
39、. 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 4.5 can be used to demonstr
40、ate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic present
41、ation (e.g. inner wrap, container filter, 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.
42、 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 868-2, Packaging for t
43、erminally sterilized medical devices Part 2: Sterilization wrap Requirements and test methods EN 868-3, 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-
44、5) Requirements and test methods EN 868-6, Packaging for terminally sterilized medical devices Part 6: Paper for low temperature sterilization process Requirements and test methods EN 868-7, Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterili
45、zation processes Requirements and test methods EN 868-9, Packaging for terminally sterilized medical devices Part 9: Uncoated nonwoven materials of polyolefines Requirements and test methods EN 868-10, Packaging for terminally sterilized medical devices Part 10: Adhesive coated nonwoven materials of
46、 polyolefines Requirements and test methods EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General requirements (ISO 11140-1:2005) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems a
47、nd packaging systems (ISO 11607-1:2006) ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN 868-5:2009-09 EN 868-5:2009 (E) 6 ASTM D 882:1995, Test Methods for Tensile Properties of the Thin Plastic Sheeting 3 Terms and definitions For the
48、 purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 and the following apply. 3.1 healthcare facility location where patients are medically treated and/or medical devices are terminally sterilized EXAMPLE Hospital, dentist office, practitioner. 4 Requirements 4.1 Genera
49、l The requirements of EN ISO 11607-1 apply. NOTE 1 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). NOTE 2 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2. 4.2 Materials 4.2.1 Porous material The porous material shall comply with the requirements of either EN
