EN 868-9-2009 en Packaging for terminally sterilized medical devices - Part 9 Uncoated nonwoven materials of polyolefines - Requirements and test methods《灭菌医疗装置的包装 第9部分 聚烯烃非包覆非织物材料.pdf

1、BS EN 868-9:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging for terminally sterilized medical devicesPart 9: Uncoated nonwoven materials of polyolefines Requirements and test methodsThis British Standardwas published under thea

2、uthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 59168 6Amendments/corrigenda issued since publicationDate CommentsBS EN 868-9:2009National forewordThis British Standard is the UK implementation of EN 868-9:2009. Itsupersedes BS EN 868-9:2000 which is wi

3、thdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisi

4、onsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 868-9:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-9May 2009ICS 11.080.30 Supersedes EN 868-9:2000 English VersionPackaging for termi

5、nally sterilized medical devices - Part 9:Uncoated nonwoven materials of polyolefines - Requirementsand test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 9: Non tisss base depolyolfines, non enduits, pour la fabrication de sachets,gaines et opercules the

6、rmoscellables - Exigences etmthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 9: UnbeschichteteFaservliesmaterialien aus Polyolefinen - Anforderungenund PrfverfahrenThis European Standard was approved by CEN on 23 April 2009.CEN members are bound to comply w

7、ith 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 nationalstandards may be obtained on application to the CEN Management Ce

8、ntre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial

9、 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,

10、 Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Me

11、mbers.Ref. No. EN 868-9:2009: EBS EN 868-9:2009EN 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 .6

12、5 Information to be supplied by the manufacturer 7Annex A (informative) Details of significant technical changes between this European Standard and the previous edition .8Bibliography 9BS EN 868-9:2009EN 868-9:2009 (E) 3 Foreword This document (EN 868-9:2009) has been prepared by Technical Committee

13、 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

14、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 868-9:2000. Anne

15、x 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

16、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 R

17、equirements 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

18、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

19、 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 form

20、ing, 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, Germa

21、ny, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 868-9:2009EN 868-9:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts un

22、der 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 ste

23、rilized 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

24、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/W

25、G 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 a

26、lso 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. BS EN 868-

27、9:2009EN 868-9:2009 (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

28、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

29、 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. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic

30、presentation (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

31、 apply. The materials 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

32、of the referenced 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 (I

33、SO 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: Requirem

34、ents for materials, 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 elem

35、ents and interchange 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. BS EN 868-9:2

36、009EN 868-9:2009 (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 un

37、coated material 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 method

38、s 4.3.1 No colour 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 accordanc

39、e with EN ISO 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

40、 The internal 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

41、D 2724:1987. 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

42、. 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 conditioned material shall be determined using the hydrostatic head test based on EN 20811. This test method is currently under revision and

43、considering other test conditions (use of support screen with an open area greater than 50 % in order to avoid early fabric rupture). Minimum requirements will be set as soon as the revised test method is available. Manufacturers may report test results. 4.4 Marking of the protective packaging The p

44、rotective packaging shall be legibly and durably marked with the following information: a) reference, stock or catalogue number; b) quantity; c) the manufacturers or suppliers name or trade name, and address; BS EN 868-9:2009EN 868-9:2009 (E) 7 d) date of manufacture in accordance with ISO 8601; e)

45、lot number1; f) nominal mass in grams per square metre; g) nominal sheet size in millimetres or nominal width of rolls in millimetres and length in metres; h) the recommended storage conditions. 5 Information to be supplied by the manufacturer For requirements on information to be provided by the ma

46、nufacturer national or regional legislation may apply, see in particular Directive 93/42/EEC, Annex I, Section 13. 1 A reference number in order to trace the manufacturing history of the product. BS EN 868-9:2009EN 868-9:2009 (E) 8 Annex A (informative) Details of significant technical changes betwe

47、en this European Standard and the previous edition Changes between this European Standard and EN 868-9:2000 are the following: a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by 1) amending the main element of the title, the scope and the terminology;

48、2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems; 3) deleting requirements that are covered by EN ISO 11607 (such as requirements on raw materials, conditioning, quality of the material with regard to tears

49、, creases, localised thickening, leaching of toxic substances); b) in addition to a) first dash, the scope has been modified to 1) explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; 2) clarify that the materials covered by this European Standard are 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 pr