EN 868-5-2009 en Packaging for terminally sterilized medical devices - Part 5 Sealable pouches and reels of porous materials and plastic film construction - Requirements and test m.pdf

1、BS EN 868-5:2009ICS 11.080.30; 55.040; 55.080NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging for terminally sterilized medical devicesPart 5: Sealable pouches and reels of porous materials and plastic film construction Requirements and test methodsThis

2、 British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009. BSI 2009ISBN 978 0 580 55005 8Amendments/corrigenda issued since publicationDate CommentsBS EN 868-5:2009National forewordThis British Standard is the UK implementation of EN 868-5:2009.

3、 Itsupersedes BS EN 868-5:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations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 pu

4、rport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 868-5:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-5May 2009ICS 11.080.30 Supersedes EN 868

5、-5:1999 English VersionPackaging for terminally sterilized medical devices - Part 5:Sealable pouches and reels of porous materials and plastic filmconstruction - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 5: Sachets et gainestherm

6、oscellables constitus dune face matire poreuse etdune face film plastique - Exigences et mthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 5: Siegelfhige Klarsichtbeutel und -schluche aus porsem Material und Kunststoff-Verbundfolie - Anforderungen und Prfver

7、fahrenThis 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical r

8、eferences concerning such nationalstandards 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 translationunder the responsibility of a CEN member

9、 into its own language and notified to the CEN Management 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, Latvi

10、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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 200

11、9 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 868-5:2009: EBS EN 868-5:2009EN 868-5:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Requirements .65 Information to be

12、 supplied by the manufacturer 8Annex A (informative) Details of significant technical 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 determinat

13、ion of pinholes in plastic laminate 12Annex D (normative) Method for the determination 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 th

14、e determination of fibre orientation 17Bibliography . 18BS EN 868-5:2009EN 868-5:2009 (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 th

15、e 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

16、 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 868-5:1999. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consists of

17、 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

18、-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: Ad

19、hesive 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

20、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

21、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 organizat

22、ions 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, Romani

23、a, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 868-5:2009EN 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

24、 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 ass

25、embly 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 C

26、EN/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

27、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 agre

28、ed 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. BS EN 868-5:2009EN 868-5:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for sealable pouches and reels manufacture

29、d from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 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

30、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

31、such, the particular requirements in 4.2 to 4.5 can be used to demonstrate 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 barr

32、ier system in order to ease the organization, drying or aseptic 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 ac

33、ceptability 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

34、 document (including any amendments) applies. EN 868-2, Packaging for terminally 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 8

35、68-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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 me

36、dical devices Part 7: Adhesive coated paper for low temperature sterilization 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 st

37、erilized medical devices Part 10: Adhesive coated nonwoven materials of 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 medica

38、l devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times BS EN 868-5:2009EN 868-5:2009 (E) 6 ASTM D 882:1995, Test Methods for Tensile Prope

39、rties of the Thin Plastic Sheeting 3 Terms and definitions For the 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

40、 Hospital, dentist office, practitioner. 4 Requirements 4.1 General 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).

41、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 868 part 2, 3, 6, 7, 9 or 10. When the porous material is to be used to manufacture preformed st

42、erile barrier systems intended to be irradiation sterilized only, requirements for wet strength properties or permeability to air need not apply. 4.2.2 Plastic film 4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance

43、 with Annex B the plastics interply bond shall not separate nor become cloudy. 4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C. 4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic

44、 film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4.5. NOTE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect. 4.2.2.4 The plastic film shall be sealable

45、 to the porous material under the conditions specified by the manufacturer (see Clause 5, NOTE 1). 4.2.2.5 The breaking factor of the plastics film shall be not less than 20 N per 15 mm width when tested in accordance with ASTM D 882:1995 (Method A). BS EN 868-5:2009EN 868-5:2009 (E) 7 4.3 Construct

46、ion and design 4.3.1 Reel material shall be constructed from one layer of porous material and one layer of plastics film, sealed together along parallel sides. Pouches shall be constructed from one layer of porous material and one layer of plastic film by sealing three sides and may include an area

47、to effect closure of the pouch. 4.3.2 The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the widths of the ribs shall be not less than 6 mm. 4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable

48、 the two webs to be separated and peeled apart. NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided that this does not impair peelability. 4.3.4 One of the materials of a pouch shall: a) be provided with a thumb notch not more than 12 mm deep at either the top

49、or bottom of the pouch or at both ends. The bottom of the notch shall be at least 1 mm from the seal; or b) be lipped such that the length of one web is greater than the length of the other web by not less than 1,0 mm. 4.3.5 The pouch and/or reel shall be closed according to the manufacturers instructions. NOTE 1 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2. NOTE 2 The closure and or sealing system may give the possibility to