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1、BRITISH STANDARDPackaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methodsThe European Standard EN 868-6:1999 has the status of aBritish Sta
2、ndardICS 11.080.30; 55.040;| BS EN868-6:1999|Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-6:1999National forewordThis British Standar
3、d is the English language version of EN 868-6:1999.The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/9, Sterilization packaging materials, which has the responsibility to: aid enquirers to understand
4、the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK.A list of organizations represented on this subcommittee can
5、 be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using theFind
6、facility of the BSI Standards Electronic Catalogue.Sterilization packaging materials falling within the scope of EN 868-1 are considered to be medical devices under Directive 93/42/EEC and compliance with the requirements of EN 868-1 is a means of ensuring that particular essential requirements of t
7、he Directive are met (see Annex ZA of EN 868-1). This Part ofEN 868 may be used to demonstrate compliance with some of the requirements of Part 1. However, compliance with this Part of EN 868 alone may not necessarily be considered to ensure that the essential requirements of the Directive have been
8、 met.A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprise
9、s a front cover, an inside front cover, the EN title page, pages 2 to 7 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontroll
10、ed Copy, (c) BSIAmd. No.DateCommentsThis British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the StandardsCommittee and comes into effect on 15 November 1999BSI 11-1999ISBN 0 580 35313 3Amendments issued
11、 since publicationEUROPEAN STANDARDEN 868-6NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.080; 55.040English versionPackaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irra
12、diation Requirements and test methodsMate riaux et syste mes demballages pour les dispositifs me dicaux devant e tre ste rilise s Partie 6: Papier pour la fabrication demballages a usage me dical pour ste rilisation par loxyde dethyle ne ou par irradiation Exigences etme thodes dessaiVerpackungsmate
13、rialien und -systeme fu r zu sterilisierende Medizinprodukte Teil 6: Papier fu r die Herstellung von Verpackungen fu r medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen Anforderungen und Pru fverfahrenLicensed Copy: London South Bank University, London South Bank University, Wed Ju
14、l 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSIThis European Standard was approved by CEN on 13 May 1999.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterat
15、ion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translati
16、on under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy
17、, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1999 CEN All rights of exploitation in any
18、form and by any means reserved worldwide for CEN nationalMembers.Ref. No. EN 868-6:1999 EPage 7EN 868-6:1999BSI 11-1999ForewordThis European Standard has been prepared byTechnical Committee CEN/TC 102, Sterilizers forContentsPageLicensed Copy: London South Bank University, London South Bank Universi
19、ty, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSImedical purposes, the Secretariat of which is held byDIN.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 byDecember 1999, and conflicting n
20、ational standards shall be withdrawn at the latest by December 1999.This standard is one of a series of European Standards concerned with packaging materials and systems for medical devices which are to be sterilized. This series consists of the following parts:EN 868-1, Packaging materials and syst
21、ems for medical devices which are to be sterilized Part 1: General requirements and test methods. EN 868-2, Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methods.EN 868-3, Packaging materials and systems for medical de
22、vices which are to be sterilized 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 inEN 868-5) Requirements and test methods.EN 868-4, Packaging materials and systems for medical devices which are to be sterilized Pa
23、rt 4: Paper bags Requirements and test methods.EN 868-5, Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self sealable pouches and reels of paper and plastic film construction Requirements and test methods.EN 868-6, Packaging materials and systems for
24、medical devices which are to be sterilized Part 6: Paper for the manufacture of packs formedical use for sterilization by ethylene oxide or irradiation Requirements and test methods.EN 868-7, Packaging materials and systems for medical devices which are to be sterilized Part 7: Adhesive coated paper
25、 for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methods.EN 868-8, Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers confo
26、rming to EN 285 Requirements and test methods.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irelan
27、d, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.Foreword 2Introduction 31Scope 32Normative references 33Definitions 34Requirements 3Annex A (normative) Method for thedetermination of water repellency 5Annex B (normative) Method for thedeterminat
28、ion of pore size 5Annex C (informative) Dimensions andtolerances 7Annex D (informative) Bibliography 7Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSIIntroductionPart 1 of this series of European Standards specifies g
29、eneral requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging.1 ScopeThis part of the series of EN 868 provides examples of particular requirements and test methods for paper use
30、d in the manufacture of packs for medical use.It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate complian
31、ce with one or more but not all of the requirements of Part 1.The paper specified in this part of the series EN 868 is suitable for the manufacture of packages to be used in ethylene oxide or irradiation sterilization processes.Paper specified in this part of the series EN 868 is intended for use in
32、 part or complete manufacture of pouches and form and fill packs and lidding material for packs.2 Normative referencesThis European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and
33、 the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard onlywhen incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies.EN
34、868-1, Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods.EN 20187, Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples(ISO 187:1990).
35、EN 20535, Paper and board Determination of water absorptiveness Cobb method(ISO 535:1991).EN 21974, Paper Determination of tearing resistance (Elmendorf method)(ISO 1974:1990).EN 28601, Data elements and interchange formats Information interchange Representation of dates and times(ISO 8601:1988 and
36、technical corrigendum 1:1991).EN ISO 1924-2, Paper and board Determination of tensile properties Part 2: Constant rate of elongation method(ISO 1924-2:1994).ISO 536, Paper and board Determination of grammage.ISO 2758, Paper Determination of bursting strength. ISO 3689, Paper and board Determination
37、ofbursting strength after immersion in water(Revision of ISO 3689:1976).ISO 3781, Paper and board Determination of tensile strength after immersion in water.ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method.ISO 6588, Paper, board and pulps Determinatio
38、n of pH of aqueous extracts.ISO 9197-1, Paper, board and pulps Determination of water-soluble chlorides Part 1: General method.ISO 9198, Paper, board and pulps Determination of water-soluble sulfates Titrimetric method.DIN 58953-6:1987, Sterilization Sterile supply Sterilization paper for bags and t
39、ube packaging Test.3 DefinitionsFor the purposes of this European Standard, the definitions of EN 868-1 apply.4 Requirements4.1 GeneralThe requirements of EN 868-1 apply.NOTE The following particular requirements and test methods can be used to demonstrate compliance with one or more but not all of
40、the requirements of EN 868-1.4.2 Materials4.2.1 Raw materials used for the manufacture of packaging materials may be virgin or reclaimed materials provided that the source, history and traceability of all raw materials, especially recycled materials, are known and controlled to ensure that the finis
41、hed product will consistently meet the requirements of this standard.NOTE With current commercial technologies it is unlikely that reclaimed material other than manufacturing waste will be sufficiently controlled to allow its safe use for medical device packaging.4.2.2 The pulp shall be free from gr
42、it and untreated fragments of the original materials from which the pulp was prepared.4.3 ConditioningWhere reference is made in the following performance requirements to conditioned paper or to the need for conditioning prior to carrying out a test the paper shall be conditioned in accordance with
43、the method given in EN 20187.4.4 Performance requirements and test methodsNOTE When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is not necessary for it to have wet strength properties or any permeability to air,so 4.4.12, 4.4.13 and 4.4.16 need not
44、 apply.4.4.1 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the paper shall be free from pinholes, tears, creases or localized thickening sufficient to impair its functioning.4.4.2 No colour shall leach out of the paper. Compliance shall
45、be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588.4.4.3 NOTE The paper can be printed.Whether printed or not, no substance known to be toxic shall leach out of the paper in sufficient quantity to cause a health hazard.Until relevant European or International Standards are publis
