BS EN 868-10-2009 Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods《最终灭菌医疗器械的包装 聚烯烃粘性涂覆非织物材料 .pdf

1、BS EN868-10:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging materialsfor terminallysterilized medicaldevicesPart 10: Adhesive coated nonwovenmaterials of polyolefines Requirements and test methodsThis British Standardwas publis

2、hed under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 59169 3Amendments/corrigenda issued since publicationDate CommentsBS EN 868-10:2009National forewordThis British Standard is the UK implementation of EN 868-10:2009. Itsupersedes BS EN 868-10

3、:2000 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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

4、necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 868-10:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-10May 2009ICS 11.080.30 Supersedes EN 868-10:2000 English Versio

5、nPackaging for terminally sterilized medical devices - Part 10:Adhesive coated nonwoven materials of polyolefines -Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 10: Non tisss basede polyolfines, enduits dadhsif, pour la fabrication d

6、esachets, gaines et opercules thermoscellables - Exigenceset mthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 10: KlebemittelbeschichteteFaservliesmaterialien aus Polyolefinen - Anforderungenund PrfverfahrenThis European Standard was approved by CEN on 23 A

7、pril 2009.CEN members are 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 nationalstandards may be obtai

8、ned 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Managemen

9、t Centre has the same 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, Po

10、land, Portugal,Romania, Slovakia, Slovenia, 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

11、means reservedworldwide for CEN national Members.Ref. No. EN 868-10:2009: EBS EN 868-10:2009EN 868-10:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .65 Information to be supplied by the manufacturer 7Annex A (informative)

12、Details of significant technical changes between this European Standard and the previous edition .8Annex B (normative) Method for the determination of mass per unit area of uncoated nonwoven polyolefine materials and adhesive coating .9Annex C (normative) Method for the determination of the seal str

13、ength and visual inspection of the adhesive coating 11Bibliography . 13BS EN 868-10:2009EN 868-10:2009 (E) 3 Foreword This document (EN 868-10:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. This European Standard

14、 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 th

15、is 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 868-10:2000. Annex A provides details of significant technical changes between this European Standard and the previous edition.

16、 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 (

17、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

18、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

19、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

20、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

21、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, Polan

22、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 868-10:2009EN 868-10:2009 (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

23、 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 for

24、ming, 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 re

25、cognized 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

26、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 s

27、tandards. 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 868-10:2009EN 868-10:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for sealable adhesi

28、ve coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 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 protective packaging

29、 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 nor modify the general requirements specified in EN ISO 11607-1. As such, the particula

30、r 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. inner wrap, conta

31、iner 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 materials specified in t

32、his 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 document (includin

33、g 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 ISO 1924-2, Paper an

34、d 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

35、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 interchange formats Informa

36、tion 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 868-10:2009EN 868-10:2009 (E) 6 4 Requireme

37、nts 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 4.2.1 The coated material shall be trans

38、lucent 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. 4.2.2 The coated material shall not react with, contaminate, transfer to,

39、or adversely affect the product packed in it, before, during or after sterilization. 4.3 Performance requirements and test methods 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 65

40、88-2 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 536 shall be within 15 % 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 k

41、N/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 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.

42、 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. 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

43、 the conditioned material shall be not less than 0,3 m/Pa s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636-3. 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 nonwoven wrap

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

45、e revised test method is available. Manufacturers may report test results. 4.3.9 The mass per unit of the seal adhesive coating shall be within 2 g/m of that stated by the manufacturer. Compliance shall be tested in accordance with the method given in Annex B. 4.3.10 The seal strength of the coated

46、material shall be greater than 0,08 kN/m when tested in accordance with Annex C. BS EN 868-10:2009EN 868-10:2009 (E) 7 Report whether the tail was supported or unsupported, see C.5. 4.3.11 The coating shall be continuous and regular with no uncoated areas or discontinuity in the coating pattern whic

47、h could provide gaps or channels in a seal. NOTE The test method for the determination of the continuity of the coating depends on the applied coating system. 4.4 Marking of the protective packaging The protective packaging shall be legibly and durably marked with the following information: a) refer

48、ence, stock or catalogue number; b) quantity; c) the manufacturers or suppliers name or trade name, and address; d) date of manufacture in accordance with ISO 8601; e) lot number1; f) nominal mass in grams per square metre; g) nominal sheet size in millimetres or nominal width of rolls in millimetre

49、s and length in metres; h) the recommended storage conditions. 5 Information to be supplied by the manufacturer The manufacturer shall supply instructions for recommended sealing and/or closure conditions and for the monitoring of critical parameters of seal and/or closure integrity. NOTE 1 For validation of closure and sealing conditions, see EN ISO 11607-2. NOTE 2 For heat seals, these parameters include the range of temperature, pressure and time. NOTE 3 For requirements