1、BS EN 868-4:2009ICS 11.080.30; 55.040; 55.080NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging materialsfor terminallysterilized medicaldevicesPart 4: Paper bags Requirements andtest methodsCopyright European Committee for Standardization Provided by IHS
2、 under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 54956 4Amendments/corrigenda issued since publicationD
3、ate CommentsBS EN 868-4:2009National forewordThis British Standard is the UK implementation of EN 868-4:2009. Itsupersedes BS EN 868-4:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organi
4、zations represented on this committee can be obtained onrequest to its secretary.This publication does not purport 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.C
5、opyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-4:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-4May 2009ICS 11.080.30 Supersedes EN 868-4:1999 English Versi
6、onPackaging for terminally sterilized medical devices - Part 4:Paper bags - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 4: Sacs en papier -Exigences et mthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinpro
7、dukte - Teil 4: Papierbeutel - Anforderungen undPrfverfahrenThis 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
8、any alteration. Up-to-date lists and bibliographical references 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
9、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 versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Ge
10、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, 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 NORMUNGMa
11、nagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 868-4:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction
12、 or networking permitted without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (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 8Annex A (informative) Details of significant
13、technical changes between this European Standard and the previous edition .9Annex B (normative) Method for the determination of ph value, chloride and sulphate in paper bags 10Annex C (normative) Method for the determination of the tensile strength of the back seam joint in paper bags (see 4.5.4) 11
14、Bibliography . 12Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (E) 3 Foreword This document (EN 868-4:2009) has been prepared by Technical Committ
15、ee 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 b
16、e 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 868-4:1999. An
17、nex 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: Pape
18、r 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
19、 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 test methods; Part 8: Re-usable sterilization containers for steam sterilizers conformin
20、g 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 wi
21、th 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 fo
22、rming, 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, Ger
23、many, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for
24、ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (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 requirement
25、s 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 as
26、sembly 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
27、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 EN 868 parts 2 to 10
28、 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 agr
29、eed 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. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitt
30、ed without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of EN 868, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of t
31、erminally 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. 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
32、does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.6 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 si
33、ngle use only. 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, container filter indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the
34、 medical device) then other requirements, including the determination of the acceptability 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 edit
35、ion cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 8683, Packaging for terminally sterilized medical devices Part 3: Paper for use in the manufacture of paper bags (specified in EN 8684) and in the manufacture of pouches an
36、d reels (specified in EN 8685) Requirements and test methods EN ISO 1924-2, Paper and board Determination of tensile properties Part 2: Constant rate of elongation method (ISO 1924-2:1994) EN ISO 111401, Sterilization of health care products Chemical indicators Part 1: General requirements (ISO 1114
37、0-1:2005) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 6588-2:2005, Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction ISO 8601, Dat
38、a elements and interchange formats Information interchange Representation of dates and times ISO 9197, Paper, board and pulps Determination of water-soluble chlorides ISO 9198, Paper, board and pulp Determination of water-soluble sulfates 3 Terms and definitions For the purposes of this document, th
39、e terms and definitions given in EN ISO 11607-1:2006 apply. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (E) 6 4 Requirements 4.1 General The req
40、uirements 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 proces
41、ses, see EN ISO 11607-2. 4.2 Construction and design 4.2.1 General 4.2.1.1 The bags shall be manufactured from single web paper specified in EN 868-3. 4.2.1.2 The following terms shall be used to describe the design of the bag: a) back the surface of the bag with a longitudinal seam; b) front the su
42、rface of the bag with no longitudinal seam; c) unlipped where the length of both the front and back surfaces are the same and the front surface has a thumb cut (9 3) mm deep and not less than 15 mm wide; d) lipped where the length of the back surface is greater than the length of the front surface b
43、y not less than 10 mm and not more than 25 mm; e) gusseted where the construction of the bag includes side panels; f) ungusseted where the longitudinal edges of the front and back surfaces are contiguous; g) seal top where there is a continuous strip of seal adhesive on the inner surface of the fron
44、t, back and gussets (if gusseted) of the top of the bag; h) plain top where there is no seal adhesive. 4.2.1.3 The adhesive(s) used in the construction of the bag shall be water resistant and non-corrosive, subsequently referred to as “construction adhesive(s)“. 4.2.2 Bottom seal formation The botto
45、m seal shall be formed by using one of the following methods: a) the bottom shall be double folded with each fold bonded with “construction adhesive“, or b) the bottom shall be sealed across the entire width with a “construction adhesive“ or with a seal not less than 6,5 mm in depth, or c) the botto
46、m shall be sealed across the entire width as described in b) and then folded once, or more, each fold being bonded with (a) construction adhesive(s) or with a heat seal. 4.2.3 Back seam construction 4.2.3.1 The longitudinal seam shall be made at the back of the bag with a continuous double line of “
47、construction adhesive(s)“. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-4:2009EN 868-4:2009 (E) 7 4.2.3.2 A coloured adhesive shall be used to enable a simple visual
48、 check on the continuity of both glue lines. 4.2.3.3 The dye shall not impair the adhesive. 4.3 Process indicator If one or more Class I indicator(s) (process indicator(s) are printed on the pouches and tubes, the indicators performance shall comply with the requirements of EN ISO 11140-1. Each individual indicator shall be not less than 100 mm in area. Indicators shall not be affected by the sealing procedure. 4.4 Seal strip 4.4.1 For bags with a seal closure the seal adhesive shall be applied as a continuous strip to the inner surface
