1、September 2009DEUTSCHE NORM English price group 9No 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!$YVf“154516
2、7www.din.deDDIN EN 868-9Packaging for terminally sterilized medical devices Part 9: Uncoated nonwoven materials of polyolefines Requirements and test methodsEnglish version of DIN EN 868-9:2009-09Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 9: Unbeschichtete Faservlie
3、smaterialien aus Polyolefinen Anforderungen und PrfverfahrenEnglische Fassung DIN EN 868-9:2009-09SupersedesDIN EN 868-9:2000-03www.beuth.deDocument comprises pages13DIN EN 868-9:2009-09 National foreword This standard has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purp
4、oses” (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 corresponding to the International Standard referred to in this document
5、 is as follows: ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN 868-9:2000-03 as follows: a) Changes in order to align this European Standard with the DIN EN ISO 11607 series, in particular by amending the main element of the title, the scope and the terminology; using DIN EN ISO
6、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 raw materials, conditioning, quality of the material with regard to tears, creases, loca
7、lised thickening, leaching of toxic 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 ar
8、e intended for single use only. c) An explanatory note has been inserted to refer the user of this European Standard to the general requirements on conditions during production and handling with respect to their impact on the product in DIN EN ISO 11607. d) Requirements on tensile strength in machin
9、e direction and on bursting strength have been amended. e) The requirement on the tolerance of the thickness of the material has been deleted. f) The requirement on resistance to water penetration has been formulated by taking into consideration that the applicable test method in DIN EN 20811 is cur
10、rently under revision and that a value on resistance to water penetration can only be set on the basis of data received with this revised test method. g) Requirements on marking have been amended. h) Requirements on information to be provided by the manufacturer have been added. i) The informative a
11、nnex on dimensions and tolerances has been deleted. j) The text has been editorially revised (e. g. by updating normative and informative references). Previous editions DIN EN 868-9: 2000-03 2 DIN EN 868-9:2009-09 National Annex NA (informative) Bibliography DIN ISO 8601, Data elements and interchan
12、ge formats Information interchange Representation of dates and times 3 DIN EN 868-9:2009-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-9 May 2009 ICS 11.080.30 Supersedes EN 868-9:2000English Version Packaging for terminally sterilized medical devices
13、 Part 9: Uncoated nonwoven materials of polyolefines Requirements and test methods Matriaux demballage pour les dispositifs mdicaux striliss au stade terminal Partie 9: Non tisss base de polyolfines, non enduits, pour la fabrication de sachets, gaines et opercules thermoscellables Exigences et mthod
14、es dessai Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 9: Unbeschichtete Faservliesmaterialien aus Polyolefinen Anforderungen und Prfverfahren This European Standard was approved by CEN on 23 April 2009. CEN members are bound to comply with the CEN/CENELEC Internal Re
15、gulations 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. Th
16、is 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
17、 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, Switzer
18、land 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 worldwide for CEN national Members. Ref. No. EN
19、 868-9:2009: EEN 868-9:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .64.1 General 64.2 Materials .64.3 Performance requirements and test methods 64.4 Marking of the protective packaging .65 Information to be supplied by t
20、he manufacturer 7Annex A (informative) Details of significant technical changes between this European Standard and the previous edition .8Bibliography 9DIN EN 868-9:2009-09 EN 868-9:2009 (E) 3 Foreword This document (EN 868-9:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
21、 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 N
22、ovember 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 868-9:2000. Annex A provides details of sign
23、ificant 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 o
24、f 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
25、; 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 t
26、est 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
27、 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 pr
28、ocesses (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
29、, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 868-9:2009-09 EN 868-9:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “
30、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
31、 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 specif
32、ied 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 rev
33、iew 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 ini
34、tiatives 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. DIN EN 868-9:2009-09 EN 868-9:200
35、9 (E) 5 1 Scope This part of EN 868 provides test methods and values for uncoated nonwoven materials of polyolefines used for 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 p
36、rotective 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 s
37、uch, 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. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g.
38、 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. The materi
39、als specified in this part of EN 868 are intended for single use only. 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
40、document (including any amendments) applies. EN 20811, Textiles Determination of resistance to water penetration Hydrostatic pressure test 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 IS
41、O 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
42、, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 6588-2, Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction ISO 8601, Data elements and interchan
43、ge formats Information interchange Representation of dates and times ASTM D 2724:1987, Test Methods for Bonded, Fused and Laminated Apparal Fabrics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply. DIN EN 868-9:2009-09 EN 868-9:2
44、009 (E) 6 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 Materials The uncoated materi
45、al shall be translucent or opaque and made of continuous filaments of polyolefines of a high level of purity and shall not release any substances in such quantities as could constitute a health risk. NOTE Attention is drawn to EN ISO 10993-1. 4.3 Performance requirements and test methods 4.3.1 No co
46、lour shall leach out of the material. Compliance shall be tested by visual examination of a hot extract prepared in accordance with the method given in ISO 6588-2 modified to test temperature of (60 5) C. 4.3.2 The average mass of 1 m of the conditioned material when tested in accordance with EN ISO
47、 536 shall be within 7 % of the nominal value stated by the manufacturer. 4.3.3 The tensile strength of the conditioned material shall be not less than 4,8 kN/m in the machine direction and not less than 5,0 kN/m in the cross direction when tested in accordance with EN ISO 1924-2. 4.3.4 The internal
48、 tearing resistance of the conditioned material shall be not less than 1 000 mN in both machine and cross directions when tested in accordance with EN 21974. 4.3.5 The delamination factor of the conditioned material shall be not less than 1 N/25,4 mm when tested in accordance with ASTM D 2724:1987.
49、4.3.6 The bursting strength of the conditioned material shall be not less than 575 kPa when tested in accordance with EN ISO 2758. 4.3.7 The air permeance of the conditioned material shall be not less than 1 m/Pa s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636-3. NOTE This requirement need not to apply to materials solely for use in irradiation sterilization packaging. 4.3.8 The resistance to water penetration of the conditione
